Back to resultsGluten 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 (NCGS)
Primary Purpose
Non Celiac Gluten Sensitivity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High dose Gluten
Low dose Gluten
Lactose free placebo
Sponsored by
About this trial
This is an interventional diagnostic trial for Non Celiac Gluten Sensitivity
Eligibility Criteria
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
Sites / Locations
- Thomas Jefferson University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Lactose free placebo
Low dose Gluten (0.5g)
High Dose Gluten (2.0g)
Arm Description
Lactose free placebo pill
Low dose gluten pill
High dose gluten pill
Outcomes
Primary Outcome Measures
Patient estimated gluten intake after administration of gluten compared to baseline level on GFD, using the Celiac Dietary Adherence Test (CDAT)
NCGS symptoms, using the Celiac Symptom Index (CSI)10 after administration of gluten compared to baseline level on GFD
Stool gluten immunogenic peptides (GIP) level after administration of gluten compared to baseline level on GFD.
Urine gluten immunogenic peptides (GIP) level after administration of gluten compared to baseline level on GFD
Patient Estimation of Gluten Intake captured via (PEGI) questionnaire
Secondary Outcome Measures
Full Information
NCT ID
NCT02936297
First Posted
September 2, 2016
Last Updated
March 10, 2020
Sponsor
Thomas Jefferson University
1. Study Identification
Unique Protocol Identification Number
NCT02936297
Brief Title
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
Acronym
NCGS
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 Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Celiac Gluten Sensitivity
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lactose free placebo
Arm Type
Placebo Comparator
Arm Description
Lactose free placebo pill
Arm Title
Low dose Gluten (0.5g)
Arm Type
Active Comparator
Arm Description
Low dose gluten pill
Arm Title
High Dose Gluten (2.0g)
Arm Type
Active Comparator
Arm Description
High dose gluten pill
Intervention Type
Dietary Supplement
Intervention Name(s)
High dose Gluten
Intervention Type
Dietary Supplement
Intervention Name(s)
Low dose Gluten
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactose free placebo
Primary Outcome Measure Information:
Title
Patient estimated gluten intake after administration of gluten compared to baseline level on GFD, using the Celiac Dietary Adherence Test (CDAT)
Time Frame
12 weeks
Title
NCGS symptoms, using the Celiac Symptom Index (CSI)10 after administration of gluten compared to baseline level on GFD
Time Frame
12 weeks
Title
Stool gluten immunogenic peptides (GIP) level after administration of gluten compared to baseline level on GFD.
Time Frame
12 weeks
Title
Urine gluten immunogenic peptides (GIP) level after administration of gluten compared to baseline level on GFD
Time Frame
12 weeks
Title
Patient Estimation of Gluten Intake captured via (PEGI) questionnaire
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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
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