Effect of Secretin in Functional Dyspepsia and Healthy Subjects

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT03617861
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
• Enrollment: 20
• Location: 1
• Arms: 4
• Actual Duration (Months): 8.8
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

Insights into the pathophysiology of functional dyspepsia, with recent demonstration of inflammation with eosinophilia and mastocytosis in the duodenum (3, 6, 7), providing a possible lead toward reduced secretion of a potential mediator of post-prandial gastric accommodation, the gastrointestinal peptide hormone secretin. The dominant site of synthesis and secretion of this hormone are enteroendocrine S cells in the duodenum. Inflammation-induced damage to these cells could produce a deficiency. Since intraluminal acid is a prominent stimulant of S cell secretion, the attempts to treat functional dyspepsia with anti-secretory medications could actually exacerbate a secretin deficiency syndrome. This raises the possibility of the therapeutic use of a secretin agonist or a positive allosteric modulator of the secretin receptor for patients with functional dyspepsia.

Condition or Disease	Intervention/Treatment	Phase
Dyspepsia; Healthy	Drug: Human Secretin; Drug: Placebo	Phase 1/Phase 2

Detailed Description

The investigators will utilize single photon emission computed tomography (SPECT) methodology and gamma scintigraphy present in the GI laboratory of the outpatient Clinical Research Unit to study fasting gastric volumes and postprandial gastric accommodation responses and gastric emptying rates of a standardized meal in patients with functional dyspepsia and healthy subjects. Both groups will be studied twice, using crossover design, once with administration of secretin and once with placebo.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Masking Description: Blinded
• Primary Purpose: Treatment
• Official Title: Effect of Secretin on Gastric Accommodation, Emptying and Post-nutrient Challenge Symptoms in Functional Dyspepsia and Healthy Subjects
• Actual Study Start Date: Nov 7, 2018
• Actual Primary Completion Date: Jul 1, 2019
• Actual Study Completion Date: Aug 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Healthy Controls: Secretin Then Placebo Healthy subjects first receive human Secretin 0.2 mcg/kg via IV over 1 min on Visit Day 1. After a 1 to 4 week washout period, they received the placebo treatment (normal saline, matching Secretin dose) via IV over 1 min on Visit Day 2.	Drug: Human Secretin; Injected once over one minute; Other Names: ChiRhoStim ; Drug: Placebo; Injected once over one minute; Other Names: Normal Saline
Experimental: Healthy Controls: Placebo Then Secretin Healthy subjects first receive placebo treatment (normal saline, matching Secretin dose) via IV over 1 min on Visit Day 1. After a 1 to 4 week washout period, they received the human Secretin 0.2 mcg/kg via IV over 1 min on Visit Day 2.	Drug: Human Secretin; Injected once over one minute; Other Names: ChiRhoStim ; Drug: Placebo; Injected once over one minute; Other Names: Normal Saline
Experimental: Functional Dyspepsia: Secretin Then Placebo Functional Dyspepsia subjects first receive human Secretin 0.2 mcg/kg via IV over 1 min on Visit Day 1. After a 1 to 4 week washout period, they received the placebo treatment (normal saline, matching Secretin dose) via IV over 1 min on Visit Day 2.	Drug: Human Secretin; Injected once over one minute; Other Names: ChiRhoStim ; Drug: Placebo; Injected once over one minute; Other Names: Normal Saline
Experimental: Functional Dyspepsia: Placebo Then Secretin Functional Dyspepsia subjects first receive placebo treatment (normal saline, matching Secretin dose) via IV over 1 min on Visit Day 1. After a 1 to 4 week washout period, they received the human Secretin 0.2 mcg/kg via IV over 1 min on Visit Day 2.	Drug: Human Secretin; Injected once over one minute; Other Names: ChiRhoStim ; Drug: Placebo; Injected once over one minute; Other Names: Normal Saline

Outcome Measures

Primary Outcome Measures

1. Maximum Satiation [60 minutes]

   Thirty (30) minutes after ingesting the meal of 300 mL radio-labeled Ensure drink, an additional Ensure drink was ingested at a constant rate of 30 mL/min until maximum tolerated volume was reached.

2. Fasting Gastric Volume [Baseline]

   Gastric fasting volume was measured prior to a meal of 300 mL standardized radio-labeled Ensure drink using an intravenous injection of Technetium Tc-99m pertechnetate and noninvasive single photon emission-computed tomography (SPECT).

3. Postprandial Volume [15 minutes]

   Postprandial volume was measured 15 minutes after ingestion of 300 mL standardized radio-labeled Ensure drink using an intravenous injection of Technetium Tc-99m pertechnetate and noninvasive single photon emission-computed tomography (SPECT).

4. Change in Gastric Accommodation [Baseline, 30 minutes]

   The change in gastric accommodation was measured in mL using the difference between the fasting gastric volume and the postprandial volume.

5. Gastric Emptying [30 minutes]

   Gastric emptying was measured via scintigraphy 30 minutes after ingestion of 300 mL of radio-labeled Ensure drink and was reported as the percentage of the radio-labeled liquid meal emptied from the stomach.

6. Change in Postprandial Symptoms [Baseline, 30 minutes]

   30 minutes after ingesting a meal of 300 mL of Ensure drink postprandial symptoms of fullness, nausea, bloating and pain were measured using a horizontal visual analog scales from 0 to 100, where 0 was 'none' and 100 was 'worst ever'.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Patients with FD and prior documentation of normal or accelerated gastric emptying and/or reduced gastric accommodation.

Inclusion criteria:

• Able to provide written informed consent prior to any study procedures and be willing and able to comply with study procedures

• No medical problems or chronic diseases, other than functional dyspepsia, for that group

• Body mass index of 18-35 kg/m2

• Female subjects must have negative urine pregnancy tests and must not be lactating prior to receiving study medication and radiation exposure. For females able to bear children, a hormonal (i.e., oral, implantable, or injectable) and single-barrier method, or a double-barrier method of birth control must be used throughout the study. Female subjects unable to bear children must have this documented in the medical record [i.e., tubal ligation, hysterectomy, or post-menopausal (defined as a minimum of one year since the last menstrual period)].

Exclusion criteria:

• Unable or unwilling to provide informed consent or to comply with study procedures

• Diagnosis of other gastrointestinal diseases besides functional dyspepsia

• Structural or metabolic diseases that affect the GI system

• Unable to avoid the following over-the-counter medications 48 hours prior to the baseline period and throughout the study:

• Medications that alter GI transit or motor function including laxatives, magnesium and aluminum containing antacids, prokinetics, erythromycin, buspirone, clonidine, tricyclic antidepressants, and secretin-norepinephrine reuptake inhibitors

• Analgesic drugs including NSAIDs and COX-2 inhibitors

• NOTE: Stable doses of thyroid replacement, estrogen replacement, low-dose aspirin for cardio-protection, low stable dose antidepressants of the SSRI class, and birth control (but with adequate backup contraception, as drug interactions with birth control have not been conducted) are permissible.

• History of recent surgery (within 60 days of screening)

• Acute or chronic illness or history of illness which in the opinion of the investigator could pose a threat or harm to the subject or obscure interpretation of laboratory test results or interpretation of study data, such as frequent angina, Class III or IV congestive heart failure, moderate impairment of renal or hepatic function, poorly controlled diabetes, etc.

• Any clinically significant abnormalities on physical examination or laboratory abnormalities identified in the medical record, as determined by the investigator

• Acute GI illness within 48 hours of initiation of the baseline period

• Females who are pregnant or breastfeeding

• History of excessive alcohol use or substance abuse

• Participation in an investigational study within the 30 days prior to dosing in the present study

• Any other reason, which in the opinion of the investigator, would confound proper interpretation of the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

• Principal Investigator: Michael Camilleri, Mayo Clinic

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 19, 2019

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Michael Camilleri, MD, Professor and Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT03617861
• Other Study ID Numbers: 18-003744; R01DK115950; R01DK122280; UL1TR002377
• First Posted: Aug 7, 2018
• Last Update Posted: Jun 11, 2020
• Last Verified: Jun 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dyspepsia; Secretin

Study Results

Participant Flow

Arm/Group Title	Healthy Controls: Secretin Then Placebo	Healthy Controls: Placebo Then Secretin	Functional Dyspepsia: Secretin Then Placebo	Functional Dyspepsia: Placebo Then Secretin
Arm/Group Description	Healthy subjects first receive human Secretin 0.2 mcg/kg via IV over 1 min on Visit Day 1. After a 1 to 4 week washout period, they received the placebo treatment (normal saline matching Secretin dose) via IV over 1 min on Visit Day 2.	Healthy subjects first receive placebo treatment (normal saline matching Secretin dose) via IV over 1 min on Visit Day 1. After a 1 to 4 week washout period, they received the human Secretin 0.2 mcg/kg via IV over 1 min on Visit Day 2.	Functional Dyspepsia subjects first receive human Secretin 0.2 mcg/kg via IV over 1 min on Visit Day 1. After a 1 to 4 week washout period, they received the placebo treatment (normal saline matching Secretin dose) via IV over 1 min on Visit Day 2.	Functional Dyspepsia subjects first receive placebo treatment (normal saline matching Secretin dose) via IV over 1 min on Visit Day 1. After a 1 to 4 week washout period, they received the human Secretin 0.2 mcg/kg via IV over 1 min on Visit Day 2.
Period Title: First Intervention (1 Day)
STARTED	5	5	5	5
COMPLETED	5	5	5	5
NOT COMPLETED	0	0	0	0
Period Title: First Intervention (1 Day)
STARTED	5	5	5	5
COMPLETED	5	5	5	5
NOT COMPLETED	0	0	0	0
Period Title: First Intervention (1 Day)
STARTED	5	5	5	5
COMPLETED	5	5	4	5
NOT COMPLETED	0	0	1	0

Baseline Characteristics

Arm/Group Title	Healthy Controls	Functional Dyspepsia	Total
Arm/Group Description	Healthy controls were randomly assigned to secretin or placebo allocation before treatment. After a 1 to 4 week washout period, they received the alternate treatment from that administered on Day 1.	Functional Dyspepsia subjects were randomly assigned to secretin or placebo allocation before treatment. After a 1 to 4 week washout period, they received the alternate treatment from that administered on Day 1.	Total of all reporting groups
Overall Participants	10	10	20
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	45.0	50.5	47.0
Sex: Female, Male (Count of Participants)
Female	8 80%	7 70%	15 75%
Male	2 20%	3 30%	5 25%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	10 100%	8 80%	18 90%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	2 20%	2 10%
Region of Enrollment (participants) [Number]
United States	10 100%	10 100%	20 100%

Outcome Measures

1. Primary Outcome

Title	Maximum Satiation
Description	Thirty (30) minutes after ingesting the meal of 300 mL radio-labeled Ensure drink, an additional Ensure drink was ingested at a constant rate of 30 mL/min until maximum tolerated volume was reached.
Time Frame	60 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Healthy Controls: Secretin	Healthy Controls: Placebo	Functional Dyspepsia: Secretin	Functional Dyspepsia: Placebo
Arm/Group Description	Healthy controls who received human Secretin 0.2 mcg/kg via IV over 1 min on either the first or second study visit day.	Healthy controls who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min on either the first or second study visit day.	Functional Dyspepsia subjects who received human Secretin 0.2 mcg/kg via IV over 1 min on either the first or second study visit day.	Functional Dyspepsia subjects who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min on either the first or second study visit day.
Measure Participants	10	10	10	10
Median (Inter-Quartile Range) [mL]	892.5	951.75	655.5	892.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Healthy Controls: Secretin, Healthy Controls: Placebo
	Comments	Healthy Controls Secretin vs Healthy Controls Placebo
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.12
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Functional Dyspepsia: Secretin, Functional Dyspepsia: Placebo
	Comments	Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.65
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Healthy Controls: Secretin, Healthy Controls: Placebo, Functional Dyspepsia: Secretin, Functional Dyspepsia: Placebo
	Comments	Healthy Controls vs Functional Dyspepsia
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0574
	Comments
	Method	ANCOVA
	Comments

2. Primary Outcome

Title	Fasting Gastric Volume
Description	Gastric fasting volume was measured prior to a meal of 300 mL standardized radio-labeled Ensure drink using an intravenous injection of Technetium Tc-99m pertechnetate and noninvasive single photon emission-computed tomography (SPECT).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Healthy Controls: Secretin	Healthy Controls: Placebo	Functional Dyspepsia: Secretin	Functional Dyspepsia: Placebo
Arm/Group Description	Healthy controls who received human Secretin 0.2 mcg/kg via IV over 1 min on either the first or second study visit day.	Healthy controls who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min on either the first or second study visit day.	Functional Dyspepsia subjects who received human Secretin 0.2 mcg/kg via IV over 1 min on either the first or second study visit day.	Functional Dyspepsia subjects who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min on either the first or second study visit day.
Measure Participants	10	10	10	10
Median (Inter-Quartile Range) [mL]	171.28	152.96	227	210.2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Healthy Controls: Secretin, Healthy Controls: Placebo
	Comments	Healthy Controls Secretin vs Healthy Controls Placebo
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.85
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Functional Dyspepsia: Secretin, Functional Dyspepsia: Placebo
	Comments	Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.82
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Healthy Controls: Secretin, Healthy Controls: Placebo, Functional Dyspepsia: Secretin, Functional Dyspepsia: Placebo
	Comments	Healthy Controls vs Functional Dyspepsia
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.1451
	Comments
	Method	ANCOVA
	Comments

3. Primary Outcome

Title	Postprandial Volume
Description	Postprandial volume was measured 15 minutes after ingestion of 300 mL standardized radio-labeled Ensure drink using an intravenous injection of Technetium Tc-99m pertechnetate and noninvasive single photon emission-computed tomography (SPECT).
Time Frame	15 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Healthy Controls: Secretin	Healthy Controls: Placebo	Functional Dyspepsia: Secretin	Functional Dyspepsia: Placebo
Arm/Group Description	Healthy controls who received human Secretin 0.2 mcg/kg via IV over 1 min on either the first or second study visit day.	Healthy controls who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min on either the first or second study visit day.	Functional Dyspepsia subjects who received human Secretin 0.2 mcg/kg via IV over 1 min on either the first or second study visit day.	Functional Dyspepsia subjects who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min on either the first or second study visit day.
Measure Participants	10	10	10	10
Median (Inter-Quartile Range) [mL]	435.85	457.43	593.80	582.36

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Healthy Controls: Secretin, Healthy Controls: Placebo
	Comments	Healthy Controls Secretin vs Healthy Controls Placebo
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.85
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Functional Dyspepsia: Secretin, Functional Dyspepsia: Placebo
	Comments	Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	1.0
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Healthy Controls: Secretin, Healthy Controls: Placebo, Functional Dyspepsia: Secretin, Functional Dyspepsia: Placebo
	Comments	Healthy Controls vs Functional Dyspepsia
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.4233
	Comments
	Method	ANCOVA
	Comments

4. Primary Outcome

Title	Change in Gastric Accommodation
Description	The change in gastric accommodation was measured in mL using the difference between the fasting gastric volume and the postprandial volume.
Time Frame	Baseline, 30 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Healthy Controls: Secretin	Healthy Controls: Placebo	Functional Dyspepsia: Secretin	Functional Dyspepsia: Placebo
Arm/Group Description	Healthy controls who received human Secretin 0.2 mcg/kg via IV over 1 min on either the first or second study visit day.	Healthy controls who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min on either the first or second study visit day.	Functional Dyspepsia subjects who received human Secretin 0.2 mcg/kg via IV over 1 min on either the first or second study visit day.	Functional Dyspepsia subjects who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min on either the first or second study visit day.
Measure Participants	10	10	10	10
Median (Inter-Quartile Range) [mL]	270.44	271.01	378.6	370.2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Healthy Controls: Secretin, Healthy Controls: Placebo
	Comments	Healthy Controls Secretin vs Healthy Controls Placebo
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.92
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Functional Dyspepsia: Secretin, Functional Dyspepsia: Placebo
	Comments	Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	1.0
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Healthy Controls: Secretin, Healthy Controls: Placebo, Functional Dyspepsia: Secretin, Functional Dyspepsia: Placebo
	Comments	Healthy Controls vs Functional Dyspepsia
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.3891
	Comments
	Method	ANCOVA
	Comments

5. Primary Outcome

Title	Gastric Emptying
Description	Gastric emptying was measured via scintigraphy 30 minutes after ingestion of 300 mL of radio-labeled Ensure drink and was reported as the percentage of the radio-labeled liquid meal emptied from the stomach.
Time Frame	30 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Healthy Controls: Secretin	Healthy Controls: Placebo	Functional Dyspepsia: Secretin	Functional Dyspepsia: Placebo
Arm/Group Description	Healthy controls who received human Secretin 0.2 mcg/kg via IV over 1 min on either the first or second study visit day.	Healthy controls who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min on either the first or second study visit day.	Functional Dyspepsia subjects who received human Secretin 0.2 mcg/kg via IV over 1 min on either the first or second study visit day.	Functional Dyspepsia subjects who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min on either the first or second study visit day.
Measure Participants	10	10	10	10
Median (Inter-Quartile Range) [percentage of gastric emptying]	7.0	19.0	0	8.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Healthy Controls: Secretin, Healthy Controls: Placebo
	Comments	Healthy Secretin vs Healthy Placebo
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.004
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Functional Dyspepsia: Secretin, Functional Dyspepsia: Placebo
	Comments	Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.03
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Healthy Controls: Secretin, Healthy Controls: Placebo, Functional Dyspepsia: Secretin, Functional Dyspepsia: Placebo
	Comments	Healthy vs Functional Dyspepsia
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0355
	Comments
	Method	ANCOVA
	Comments

6. Primary Outcome

Title	Change in Postprandial Symptoms
Description	30 minutes after ingesting a meal of 300 mL of Ensure drink postprandial symptoms of fullness, nausea, bloating and pain were measured using a horizontal visual analog scales from 0 to 100, where 0 was 'none' and 100 was 'worst ever'.
Time Frame	Baseline, 30 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Healthy Controls: Secretin	Healthy Controls: Placebo	Functional Dyspepsia: Secretin	Functional Dyspepsia: Placebo
Arm/Group Description	Healthy controls who received human Secretin 0.2 mcg/kg via IV over 1 min on either the first or second study visit day.	Healthy controls who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min on either the first or second study visit day.	Functional Dyspepsia subjects who received human Secretin 0.2 mcg/kg via IV over 1 min on either the first or second study visit day.	Functional Dyspepsia subjects who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min on either the first or second study visit day.
Measure Participants	10	10	10	10
Nausea	1.5	1.5	10	4
Fullness	7	4.5	31	11
Bloating	1.5	1.5	24	26
Abdominal pain	1	2	5	10

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Healthy Controls: Secretin, Healthy Controls: Placebo
	Comments	Nausea: Healthy Controls Secretin vs Healthy Controls Placebo
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.5
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Functional Dyspepsia: Secretin, Functional Dyspepsia: Placebo
	Comments	Nausea: Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.16
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Healthy Controls: Secretin, Healthy Controls: Placebo, Functional Dyspepsia: Secretin, Functional Dyspepsia: Placebo
	Comments	Nausea: Healthy Controls vs Functional Dyspepsia
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0016
	Comments
	Method	ANCOVA
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Healthy Controls: Secretin, Healthy Controls: Placebo
	Comments	Fullness: Healthy Controls Secretin vs Healthy Controls Placebo
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.10
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Functional Dyspepsia: Secretin, Functional Dyspepsia: Placebo
	Comments	Fullness: Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.30
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Healthy Controls: Secretin, Healthy Controls: Placebo, Functional Dyspepsia: Secretin, Functional Dyspepsia: Placebo
	Comments	Fullness: Healthy Controls vs Functional Dyspepsia
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0002
	Comments
	Method	ANCOVA
	Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Healthy Controls: Secretin, Healthy Controls: Placebo
	Comments	Bloating: Healthy Controls Secretin vs Healthy Controls Placebo
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.41
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Functional Dyspepsia: Secretin, Functional Dyspepsia: Placebo
	Comments	Bloating Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.67
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Healthy Controls: Secretin, Healthy Controls: Placebo, Functional Dyspepsia: Secretin, Functional Dyspepsia: Placebo
	Comments	Bloating: Healthy Controls vs Functional Dyspepsia
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0330
	Comments
	Method	ANCOVA
	Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Healthy Controls: Secretin, Healthy Controls: Placebo
	Comments	Abdominal Pain: Healthy Controls Secretin vs Healthy Controls Placebo
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.25
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Functional Dyspepsia: Secretin, Functional Dyspepsia: Placebo
	Comments	Abdominal Pain: Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.57
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Healthy Controls: Secretin, Healthy Controls: Placebo, Functional Dyspepsia: Secretin, Functional Dyspepsia: Placebo
	Comments	Abdominal Pain: Healthy Controls vs Functional Dyspepsia
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.2375
	Comments
	Method	ANCOVA
	Comments

Adverse Events

Time Frame	Adverse events will be collected on each patient for each of the two individual study days, over a total duration of approximately one year.
Arm/Group Title	Healthy Controls: Secretin		Healthy Controls: Placebo		Functional Dyspepsia: Secretin		Functional Dyspepsia: Placebo
Arm/Group Description	Healthy controls who received human Secretin 0.2 mcg/kg via IV over 1 min.		Healthy controls who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min.		Functional Dyspepsia subjects who received human Secretin 0.2 mcg/kg via IV over 1 min.		Functional Dyspepsia subjects who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min.
All Cause Mortality
	Healthy Controls: Secretin		Healthy Controls: Placebo		Functional Dyspepsia: Secretin		Functional Dyspepsia: Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)		0/10 (0%)		0/10 (0%)
Serious Adverse Events
	Healthy Controls: Secretin		Healthy Controls: Placebo		Functional Dyspepsia: Secretin		Functional Dyspepsia: Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)		0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Healthy Controls: Secretin		Healthy Controls: Placebo		Functional Dyspepsia: Secretin		Functional Dyspepsia: Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		1/10 (10%)		10/10 (100%)		10/10 (100%)
Gastrointestinal disorders
Vomiting	0/10 (0%)	0	1/10 (10%)	1	1/10 (10%)	1	1/10 (10%)	1
Nausea	0/10 (0%)	0	0/10 (0%)	0	5/10 (50%)	5	4/10 (40%)	4
Diarrhea	0/10 (0%)	0	0/10 (0%)	0	2/10 (20%)	2	3/10 (30%)	3
Postprandial fullness	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	1/10 (10%)	1
General disorders
Abdominal pain	0/10 (0%)	0	0/10 (0%)	0	2/10 (20%)	2	1/10 (10%)	1
Headache	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	3/10 (30%)	3
Dizziness	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.