NCT01094041

Brief Summary

The specific hypotheses are: Gluten supplementation for four weeks increases small intestinal permeability and accelerates colonic transit in patients with irritable bowel syndrome with diarrhea (IBS-D) or functional diarrhea (FD) who are HLA-DQ2 positive.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2010

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

February 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 26, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

May 10, 2013

Status Verified

May 1, 2013

Enrollment Period

1.9 years

First QC Date

March 25, 2010

Last Update Submit

May 8, 2013

Conditions

DiarrheaDiarrhea Predominant Irritable Bowel Syndrome

Keywords

GlutenDiarrhea or diarrhea predominant irritable bowel syndromeColonic permeabilitySmall bowel permeabilityColonic inflammatory responseSmall bowel inflammatory response

Outcome Measures

Primary Outcomes (3)

  • Small bowel permeability

    Excretion of mannitol 0-2 hours after liquid formulation

    0 - 2 hours post sugar ingestion

  • Colonic permeability

    Cumulative excretion of mannitol at 2-24 hours after liquid

    2 -24 hours post sugars ingestion

  • Colonic transit

    Colonic transit geometric center at 24 hours

    24 hours

Secondary Outcomes (8)

  • Colon transit

    6-12 hours

  • Colonic permeability

    2-24 hours after sugars ingestion

  • Colonic permeability

    8 to 24 hours after ingestion of sugars

  • Small bowel transit time

    6 hours

  • Gastric emptying

    0-2 hours

  • +3 more secondary outcomes

Study Arms (2)

Gluten free diet

EXPERIMENTAL
Other: Gluten free diet

Gluten rich diet

EXPERIMENTAL
Other: Gluten rich diet

Interventions

Gluten free dietOTHER

A 4-week gluten free diet provided

Gluten free diet
Gluten rich dietOTHER

A 4-week gluten rich diet is provided

Gluten rich diet

Eligibility Criteria

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

You may qualify if:

  • Diarrhea or diarrhea predominant IBS patients
  • Age 18 to 65
  • BDQ confirms presence of IBS-D or functional diarrhea, positive by Rome III criteria
  • No restrictions on Hospital Anxiety Depression score
  • No abdominal surgery (except appendectomy and cholecystectomy)

You may not qualify if:

  • Serum tissue transglutaminase IgA or IgG 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)
  • Use of NSAIDs or aspirin within the past week (since NSAIDs affect intestinal permeability)
  • Use of oral corticosteroids within the previous 6 weeks
  • Ingestion of artificial sweeteners such as SplendaTM (sucralose), Nutrasweet TM(aspartame), lactulose or mannitol 2 days before the study begins, e.g., foods to be avoided are sugarless gums or mints and diet soda
  • Ingestion of any prescription, over the counter, or herbal medications which can affect gastrointestinal transit 7 days before study begins.
  • Any females who are pregnant or trying to become pregnant (due to radiation exposure)
  • Bleeding disorders or medications that increase risk of bleeding from mucosal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Vazquez-Roque MI, Camilleri M, Smyrk T, Murray JA, Marietta E, O'Neill J, Carlson P, Lamsam J, Janzow D, Eckert D, Burton D, Zinsmeister AR. A controlled trial of gluten-free diet in patients with irritable bowel syndrome-diarrhea: effects on bowel frequency and intestinal function. Gastroenterology. 2013 May;144(5):903-911.e3. doi: 10.1053/j.gastro.2013.01.049. Epub 2013 Jan 25.

    PMID: 23357715DERIVED

MeSH Terms

Conditions

Diarrhea

Interventions

Diet, Gluten-Free

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Michael Camilleri, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 25, 2010

First Posted

March 26, 2010

Study Start

February 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2013

Last Updated

May 10, 2013

Record last verified: 2013-05

Locations

US(1)