NCT02098057

Brief Summary

The overall hypothesis of this research study is that gluten intake alters intestinal barrier function in patients with Irritable Bowel Syndrome (IBS) diarrhea who also exhibit non-celiac gluten sensitivity (NCGS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

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

First Submitted

Initial submission to the registry

March 14, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 27, 2014

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2016

Completed
Last Updated

April 8, 2019

Status Verified

April 1, 2019

Enrollment Period

2.5 years

First QC Date

March 14, 2014

Last Update Submit

April 4, 2019

Conditions

Gastrointestinal Disorders

Keywords

IBS-diarrhea

Outcome Measures

Primary Outcomes (1)

  • Change in permeability of the small intestine after treatment

    Baseline to 4 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

A total of 24 patients with NCGS and 12 healthy controls will be recruited for this study. The 24 patients with NCGS will be randomized to receive one of two diets (GFD or GCD) in a 1:1 ratio

Drug: Placebo

Gluten

ACTIVE COMPARATOR

A total of 24 patients with NCGS and 12 healthy controls will be recruited for this study. The 24 patients with NCGS will be randomized to receive one of two diets (GFD or GCD) in a 1:1 ratio

Dietary Supplement: Gluten Healthy

Interventions

Gluten HealthyDIETARY_SUPPLEMENT

Assessment of current diet and amount of gluten consumed will be determined by the dietitian and by means of a questionnaire at baseline. Subjects will have a 2-week run in period, in which they will continue or initiate a gluten free diet plan prepared by the dietitians. After the run-in period, participants will be randomized to either a gluten containing diet (GCD) or placebo (GFD) for 4 weeks.

Gluten
PlaceboDRUG

A total of 24 patients with NCGS and 12 healthy controls will be recruited for this study. The 24 patients with NCGS will be randomized to receive one of two diets (GFD or GCD) in a 1:1 ratio Assessment of current diet and amount of gluten consumed will be determined by the dietitian and by means of a questionnaire at baseline. Subjects will have a 2-week run in period, in which they will continue or initiate a gluten free diet plan prepared by the dietitians. After the run-in period, participants will be randomized to either a gluten containing diet (GCD) or placebo (GFD) for 4 weeks.

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non celiac gluten sensitive patients with a functional bowel disorder
  • Age 18 to 70 years.

You may not qualify if:

  • Positive serum tissue transglutaminase (TTG) Immunoglobulin A (IgA) positive or medical record of small bowel biopsy suggestive of celiac disease.
  • Use of tobacco products within the past 6 months (since nicotine may affect intestinal permeability).
  • Abdominal surgeries (except appendectomy, cholecystectomy and vaginal hysterectomy or tubal ligation)
  • Use of Nonsteroidal Anti-inflammatory Drugs(NSAIDs) or aspirin within the past week (since Nonsteroidal Anti-inflammatory Drugs (NSAIDs) affect intestinal permeability).
  • Use of oral corticosteroids within the previous 6 weeks.
  • Ingestion of artificial sweeteners such as Sucralose, Nutrasweet ™ (aspartame), lactulose or mannitol 2 days before the study tests begins, e.g., foods to be avoided are sugarless gums or mints and diet soda.
  • Bleeding disorders or medications that increase risk of bleeding from mucosal biopsies.
  • High anxiety or depression score (\>11 on each subscale) on the Hospital Anxiety Depression Score questionnaire.
  • Known allergy to fluorescein.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Related Links

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Maria I Vazquez Roque, MD, MSc

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

March 14, 2014

First Posted

March 27, 2014

Study Start

April 1, 2014

Primary Completion

September 19, 2016

Study Completion

September 19, 2016

Last Updated

April 8, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

There is no plan to share Individual Patient Data at this time. Once data analysis is done at study conclusion, it will help determine feasibility for moving forward with another, similar - possibly larger, study. That said, data may be released after study conclusion.

Locations

US(1)