NCT02936297

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

March 11, 2020

Status Verified

March 1, 2020

Enrollment Period

2 years

First QC Date

September 2, 2016

Last Update Submit

March 10, 2020

Conditions

Non Celiac Gluten Sensitivity

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (3)

Lactose free placebo

PLACEBO COMPARATOR

Lactose free placebo pill

Dietary Supplement: Lactose free placebo

Low dose Gluten (0.5g)

ACTIVE COMPARATOR

Low dose gluten pill

Dietary Supplement: Low dose Gluten

High Dose Gluten (2.0g)

ACTIVE COMPARATOR

High dose gluten pill

Dietary Supplement: High dose Gluten

Interventions

High dose GlutenDIETARY_SUPPLEMENT
High Dose Gluten (2.0g)
Low dose GlutenDIETARY_SUPPLEMENT
Low dose Gluten (0.5g)
Lactose free placeboDIETARY_SUPPLEMENT
Lactose free placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Interventions

Glutens

Intervention Hierarchy (Ancestors)

ProlaminsGrain ProteinsPlant ProteinsProteinsAmino Acids, Peptides, and ProteinsSeed Storage Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2016

First Posted

October 18, 2016

Study Start

June 1, 2016

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

March 11, 2020

Record last verified: 2020-03

Locations

US(1)