- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02936297
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 (NCGS)
March 10, 2020 updated by: Thomas Jefferson University
Quantitative Measurement of Stool and Urine Gluten Immunogenic Peptides in Patients With Non-celiac Gluten Sensitivity and Healthy Patients: A Placebo-controlled Study Study
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Lactose free placebo
Lactose free placebo pill
|
|
Active Comparator: Low dose Gluten (0.5g)
Low dose gluten pill
|
|
Active Comparator: High Dose Gluten (2.0g)
High dose gluten pill
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
12 weeks
|
NCGS symptoms, using the Celiac Symptom Index (CSI)10 after administration of gluten compared to baseline level on GFD
Time Frame: 12 weeks
|
12 weeks
|
Stool gluten immunogenic peptides (GIP) level after administration of gluten compared to baseline level on GFD.
Time Frame: 12 weeks
|
12 weeks
|
Urine gluten immunogenic peptides (GIP) level after administration of gluten compared to baseline level on GFD
Time Frame: 12 weeks
|
12 weeks
|
Patient Estimation of Gluten Intake captured via (PEGI) questionnaire
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2016
Primary Completion (Actual)
June 1, 2018
Study Completion (Actual)
June 1, 2018
Study Registration Dates
First Submitted
September 2, 2016
First Submitted That Met QC Criteria
October 17, 2016
First Posted (Estimate)
October 18, 2016
Study Record Updates
Last Update Posted (Actual)
March 11, 2020
Last Update Submitted That Met QC Criteria
March 10, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB#16D.244
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Non Celiac Gluten Sensitivity
-
University of PalermoCompletedNon-celiac Wheat Sensitivity | Non-celiac Gluten SensitivityItaly
-
Exzell Pharma Inc.UnknownNon-Celiac Gluten SensitivityCanada
-
Maastricht UniversityUniversity of Leeds; Wageningen UniversityCompletedNon-celiac Gluten SensitivityNetherlands, United Kingdom
-
University of HohenheimCompletedNon-celiac Gluten Sensitivity | Wheat IntoleranceGermany
-
Odense University HospitalEnrolling by invitationNon-celiac Gluten Sensitivity; AdolescentsDenmark
-
Milky Way Life Sciences LLCBeth Israel Deaconess Medical CenterRecruitingCeliac Disease | Gluten Sensitivity | Non-celiac Gluten SensitivityUnited States
-
Fondazione IRCCS Ca' Granda, Ospedale Maggiore...CompletedNon Celiac Gluten SensitivityItaly
-
University of PalermoNational Research Council of ItalyNot yet recruitingNon-celiac Gluten SensitivityItaly
-
University of PalermoRecruitingNon-celiac Gluten/Wheat SensitivityItaly
-
Università degli Studi di BresciaUnknownNon Celiac Gluten SensitivityItaly
Clinical Trials on Lactose free placebo
-
Children's University Hospital, IrelandUniversity College Dublin; Health Research Board, Ireland; Medical Research Charities...Completed
-
University of Illinois at Urbana-ChampaignCompletedCognitive Change | Physiological Stress | Gastrointestinal HealthUnited States
-
American University of Beirut Medical CenterTerminatedAcute GastroenteritisLebanon
-
Services Hospital, LahoreCompletedAcute DiarrheaPakistan
-
University of Illinois at Urbana-ChampaignCompletedPhysiological Stress | Cognition - OtherUnited States
-
Isfahan University of Medical SciencesCompletedAcute DiarrheaIran, Islamic Republic of
-
Auburn UniversityNot yet recruiting
-
Skidmore CollegeCompletedObesity | Weight Loss
-
The Women and Children Hospital of An GiangCan Tho University of Medicine and PharmacyRecruitingAcute GastroenteritisVietnam
-
Mead Johnson NutritionCompletedCommon Infant Feeding ProblemsUnited States, Canada