AT005291: Glutamine for the Treatment of Patients With Irritable Bowel Syndrome

• Sponsor: Tulane University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01414244
• Collaborator: (none)
• Enrollment: 106
• Location: 1
• Arms: 2
• Duration (Months): 61.9
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

New and effective treatments are needed for patients with post-infectious irritable bowel syndrome (PI-IBS). We conducted a randomized, placebo-controlled trial to assess the efficacy and safety of glutamine, an abundant amino acid in the body and the principal fuel for enterocytes, in patients who developed diarrhea-predominant irritable bowel syndrome with increased intestinal permeability following an enteric infection.

Condition or Disease	Intervention/Treatment	Phase
Diarrhea-Predominant Irritable Bowel Syndrome	Drug: Glutamine	Phase 2

Detailed Description

In a double-blind trial, eligible adults with post-infectious IBS with increased intestinal permeability were randomly assigned to receive either glutamine (5 g three times daily) or placebo for eight weeks. The primary end point was the proportion of patients who had a reduction of ≥50 on the Irritable Bowel Severity Scoring System (IBS-SS).

Study Design

• Study Type: Interventional
• Actual Enrollment: 106 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Randomized, Placebo-Controlled Trial of Glutamine for the Treatment of Patients With Irritable Bowel Syndrome
• Study Start Date: Nov 1, 2010
• Actual Primary Completion Date: Dec 30, 2015
• Actual Study Completion Date: Dec 30, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Glutamine supplementation Glutamine	Drug: Glutamine; Drug; Other Names: L-Glutamine
Placebo Comparator: Placebo Whey protein powder	Drug: Glutamine; Drug; Other Names: L-Glutamine

Outcome Measures

Primary Outcome Measures

1. Change in the Irritable Bowel Symptom Severity Scale [baseline and 8 weeks following therapy]

   The primary outcome measure will be a change in the Irritable Bowel Symptom Severity Scale (IBS-SS) from baseline to 8 weeks at the conclusion of therapy. The IBS-SS scale ranges from 0 to 500 (worst). A decrease in 50 or greater in the IBS-SS is considered a positive response.

Secondary Outcome Measures

1. Intestinal Permeability [baseline and 8 weeks following therapy]

   The secondary outcome measure will be a change in intestinal permeability from baseline to 8 weeks at the conclusion of therapy. Intestinal permeability is measured by the urinary lactulose/mannitol ratio following ingestion of a solution of lactulose and mannitol.

2. Stool Frequency [Baseline and 8 weeks following therapy]

   Baseline and 8 week at the conclusion of therapy

3. Stool Consistency [Baseline and 8 weeks following therapy]

   Bristol Stool Scale The Bristol Stool Scale characterizes stool characteristics and ranges from a minimum score of 1 with depicts hard or constipated stool to a maximum score of 7 which is watery or diarrheal stools. In this trial, stool that is less than 7 is better and depicts a good outcome.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 72 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• men and women age 18-72 years old who developed post-infectious diarrhea-predominant IBS (D-IBS)

• increased intestinal permeability on Lactulose/Mannitol permeability test

• able and willing to cooperate with the study

• *absence of alcohol or NSAIDs ingestion for 2 weeks prior to inclusion into study and throughout the study duration

Exclusion Criteria:

• current participation in another research protocol or unable to give informed consent

• women with a positive urine pregnancy test or breastfeeding

• history of inflammatory bowel disease, lactose intolerance, and/or celiac sprue

• • hydrogen breath test for bacterial overgrowth
• • antiendomysial antibody titer

• use of nonsteroidal antinflammatory drug(NSAIDs) 2 weeks before or during the study

• known allergy to glutamine

• abdominal surgery except for removal of gallbladder, uterus, or appendix

• Abnormal blood urea nitrogen(BUN) and/or creatinine

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tulane University School of Medicine	New Orleans	Louisiana	United States	70112

Sponsors and Collaborators

• Tulane University

Investigators

• Principal Investigator: QiQi Zhou, Tulane University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nicholas Verne, Principal Investigator, Tulane University
• ClinicalTrials.gov Identifier: NCT01414244
• Other Study ID Numbers: 11-271
• First Posted: Aug 11, 2011
• Last Update Posted: Aug 9, 2017
• Last Verified: Aug 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Nicholas Verne, Principal Investigator, Tulane University: Irritable Bowel Syndrome; Glutamine; Intestinal Permeability
• Additional relevant MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea

Study Results

Participant Flow

Arm/Group Title	Glutamine	Placebo
Arm/Group Description	Oral Glutamine Powder	Oral Whey Protein Powder
Period Title: Overall Study
STARTED	54	52
COMPLETED	54	52
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Glutamine	Placebo	Total
Arm/Group Description	Oral Glutamine Powder	Oral Whey Protein Powder	Total of all reporting groups
Overall Participants	54	52	106
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32.4 (9.5)	30.9 (7.1)	31.7 (8.3)
Sex: Female, Male (Count of Participants)
Female	37 68.5%	37 71.2%	74 69.8%
Male	17 31.5%	15 28.8%	32 30.2%
Region of Enrollment (Count of Participants)
United States	54 100%	52 100%	106 100%

Outcome Measures

1. Primary Outcome

Title	Change in the Irritable Bowel Symptom Severity Scale
Description	The primary outcome measure will be a change in the Irritable Bowel Symptom Severity Scale (IBS-SS) from baseline to 8 weeks at the conclusion of therapy. The IBS-SS scale ranges from 0 to 500 (worst). A decrease in 50 or greater in the IBS-SS is considered a positive response.
Time Frame	baseline and 8 weeks following therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Glutamine	Placebo
Arm/Group Description	Oral Glutamine Powder	Oral Whey Protein Powder
Measure Participants	54	52
Mean (Standard Deviation) [units on a scale]	181 (48)	301 (57)

2. Secondary Outcome

Title	Intestinal Permeability
Description	The secondary outcome measure will be a change in intestinal permeability from baseline to 8 weeks at the conclusion of therapy. Intestinal permeability is measured by the urinary lactulose/mannitol ratio following ingestion of a solution of lactulose and mannitol.
Time Frame	baseline and 8 weeks following therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Glutamine	Placebo
Arm/Group Description	Oral Glutamine Powder	Oral Whey Protein Powder
Measure Participants	54	52
Mean (Standard Deviation) [lactulose/mannitol (L/M)]	0.05 (0.01)	0.10 (0.03)

3. Secondary Outcome

Title	Stool Frequency
Description	Baseline and 8 week at the conclusion of therapy
Time Frame	Baseline and 8 weeks following therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Glutamine	Placebo
Arm/Group Description	Oral Glutamine Powder	Oral Whey Protein Powder
Measure Participants	54	52
Mean (Standard Deviation) [stools per day]	2.9 (0.9)	5.3 (2.1)

4. Secondary Outcome

Title	Stool Consistency
Description	Bristol Stool Scale The Bristol Stool Scale characterizes stool characteristics and ranges from a minimum score of 1 with depicts hard or constipated stool to a maximum score of 7 which is watery or diarrheal stools. In this trial, stool that is less than 7 is better and depicts a good outcome.
Time Frame	Baseline and 8 weeks following therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Glutamine	Placebo
Arm/Group Description	Oral Glutamine Powder	Oral Whey Protein Powder
Measure Participants	54	52
Mean (Standard Deviation) [units on a scale (1-7)]	3.9 (1.2)	6.6 (0.53)

Adverse Events

Arm/Group Title	Glutamine		Placebo
Arm/Group Description	Oral Glutamine Powder		Oral Whey Protein Powder
All Cause Mortality
	Glutamine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/54 (0%)		0/52 (0%)
Serious Adverse Events
	Glutamine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/54 (0%)		0/52 (0%)
Other (Not Including Serious) Adverse Events
	Glutamine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/54 (0%)		0/52 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.