NCGS: Gluten Ingestion Biomarkers in Patients w Gluten Sensitivity and Healthy Controls Peptides in Patients With Non-celiac Gluten Sensitivity and Healthy Patients: A Placebo-controlled Study

Sponsor

Thomas Jefferson University (Other)

Overall Status

Completed

CT.gov ID

NCT02936297

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Non-celiac gluten sensitivity (NCGS) is an emerging clinical entity defined as the presence of intestinal and/or extraintestinal symptoms induced by the ingestion or gluten and relieved by a gluten free diet (GFD) in patients without celiac disease or wheat allergy. The pathologic mechanism of the disorder is unknown, and there are no known biomarkers or associated histopathologic findings. In this prospective, randomized controlled trail, we are investigating the utility of patient reported symptom questionnaires, as well as stool gluten and urine quantification tools in patients with NCGS and healthy controls.

Condition or Disease	Intervention/Treatment	Phase
Non Celiac Gluten Sensitivity	Dietary Supplement: High dose Gluten Dietary Supplement: Low dose Gluten Dietary Supplement: Lactose free placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Diagnostic

Official Title:

Quantitative Measurement of Stool and Urine Gluten Immunogenic Peptides in Patients With Non-celiac Gluten Sensitivity and Healthy Patients: A Placebo-controlled Study Study

Study Start Date :

Jun 1, 2016

Actual Primary Completion Date :

Jun 1, 2018

Actual Study Completion Date :

Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Lactose free placebo Lactose free placebo pill	Dietary Supplement: Lactose free placebo
Active Comparator: Low dose Gluten (0.5g) Low dose gluten pill	Dietary Supplement: Low dose Gluten
Active Comparator: High Dose Gluten (2.0g) High dose gluten pill	Dietary Supplement: High dose Gluten

Arm

Intervention/Treatment

Placebo Comparator: Lactose free placebo

Lactose free placebo pill

Dietary Supplement: Lactose free placebo

Active Comparator: Low dose Gluten (0.5g)

Low dose gluten pill

Dietary Supplement: Low dose Gluten

Active Comparator: High Dose Gluten (2.0g)

High dose gluten pill

Dietary Supplement: High dose Gluten

Outcome Measures

Primary Outcome Measures

Patient estimated gluten intake after administration of gluten compared to baseline level on GFD, using the Celiac Dietary Adherence Test (CDAT) [12 weeks]
NCGS symptoms, using the Celiac Symptom Index (CSI)10 after administration of gluten compared to baseline level on GFD [12 weeks]
Stool gluten immunogenic peptides (GIP) level after administration of gluten compared to baseline level on GFD. [12 weeks]
Urine gluten immunogenic peptides (GIP) level after administration of gluten compared to baseline level on GFD [12 weeks]
Patient Estimation of Gluten Intake captured via (PEGI) questionnaire [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion criteria include

Patients > 18 years of age
Patients willing to maintain gluten free diet for 6 weeks

Exclusion Criteria (NCGS):

Patients < 18 years of age
Patients with positive serology suggestive of celiac disease and/or biopsy-proven celiac disease and/or Human leukocyte antigen (HLA) DQ2 or DQ8 positivity.
Patients with a diagnosis of inflammatory bowel disease
Patients with a diagnosis of acute gastroenteritis
Patients who are pregnant
Type 1 Diabetes Mellitus

Exclusion criteria (healthy controls):

NCGS
Celiac disease
Inflammatory bowel disease
Irritable bowel syndrome
Acute gastroenteritis
Patients who are pregnant
Type 1 Diabetes Mellitus

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

Thomas Jefferson University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Thomas Jefferson University

ClinicalTrials.gov Identifier:

NCT02936297

Other Study ID Numbers:

IRB#16D.244

First Posted:

Oct 18, 2016

Last Update Posted:

Mar 11, 2020

Last Verified:

Mar 1, 2020

Additional relevant MeSH terms:

Hypersensitivity

Study Results

No Results Posted as of Mar 11, 2020