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Completed

NCT Number: 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

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.

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Key information

Conditions

Non Celiac Gluten Sensitivity

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High dose Gluten

Dietary Supplement

Low dose Gluten

Dietary Supplement

Lactose free placebo

Dietary Supplement

Primary outcomes

  1. 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

  2. NCGS symptoms, using the Celiac Symptom Index (CSI)10 after administration of gluten compared to baseline level on GFD

    Time frame: 12 weeks

  3. Stool gluten immunogenic peptides (GIP) level after administration of gluten compared to baseline level on GFD.

    Time frame: 12 weeks

  4. Urine gluten immunogenic peptides (GIP) level after administration of gluten compared to baseline level on GFD

    Time frame: 12 weeks

  5. Patient Estimation of Gluten Intake captured via (PEGI) questionnaire

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Registry information

Official study 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

Acronym: NCGS

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 18, 2016
Registry last updated
Mar 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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