Gluten Intolerance in Patients With Diarrhea Predominant... | NCT01094041

Studies
Gluten Intolerance in Patients With Diarrhea Predominant Irritable Bowel Syndrome

NCT01094041

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

May 10, 2013Estimated

Enrollment

50Actual

Phase

Not Applicable

Conditions

Diarrhea
Diarrhea Predominant Irritable Bowel Syndrome

Interventions

Gluten free diet
Gluten rich diet

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2010

Primary Completion Date

Jan 2012Actual

Completion Date

Jan 2013Actual

First Submitted Date

Mar 25, 2010

First Submission Date that Met QC Criteria

Mar 25, 2010

First Posted Date

Mar 26, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 8, 2013

Last Update Posted Date

May 10, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The study design is a double-blind, randomized, controlled, parallel-group, 6-week study comparing the effects of gluten rich versus gluten free diets in diarrhea or diarrhea predominant IBS patients. All participants will keep a daily bowel pattern diary throughout the study. All participants will have negative serum tissue transglutaminase (TTg) assay, and anti-endomysial antibody test, if TTg is positive or equivocal. All participants will have the following studies performed both before and after the 4-week dietary intervention:

Stool samples to check markers of inflammation such as fecal calprotectin.
Blood samples to check markers of inflammation and for genetic testing.
After ingestion of the mannitol, lactulose and sucralose sugars, urine samples to indirectly measure small intestinal and colonic permeability.
After sedation, upper gastrointestinal endoscopy and flexible sigmoidoscopy to obtain 6 mucosal biopsies from the small bowel and sigmoid colon for immunohistochemical analysis.
Scintigraphy to measure gastrointestinal transit.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gluten free diet	Experimental		Other: Gluten free diet
Gluten rich diet	Experimental		Other: Gluten rich diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gluten free diet	Other	A 4-week gluten free diet provided	Gluten free diet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Colon transit	Ascending colon emptying T1/2	6-12 hours
Colonic permeability	Cumulative excretion of lactulose	2-24 hours after sugars ingestion

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

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)

Exclusion criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Michael Camilleri, MD	Mayo Clinic	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic		Rochester	Minnesota	55905	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23357715	Derived	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.

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D004035	Diet Therapy
D044623	Nutrition Therapy
D013812	Therapeutics
D004032	Diet
D009747