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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02936297

Acronym

NCGS

Enrollment

Registered

2016-10-18

Start date

2016-06-30

Completion date

2018-06-30

Last updated

2020-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Celiac Gluten Sensitivity

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.

Interventions

DIETARY_SUPPLEMENTHigh dose Gluten

DIETARY_SUPPLEMENTLow dose Gluten

DIETARY_SUPPLEMENTLactose free placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026