DiarrheaNCT01094041
Gluten Intolerance in Patients With Diarrhea Predominant Irritable Bowel Syndrome
A study testing Gluten free diet and Gluten rich diet in people with Diarrhea and Diarrhea Predominant Irritable Bowel Syndrome, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diarrhea, Diarrhea Predominant Irritable Bowel Syndrome
- What is being tested?
- Gluten free diet and Gluten rich diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gluten Intolerance in Irritable Bowel Syndrome With Diarrhea: The Role of HLA-DQ2
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.
Read the 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.
- Being tested
- Gluten free diet, Gluten rich diet
- Keywords
- Gluten, Diarrhea or diarrhea predominant irritable bowel syndrome, Colonic permeability, Small bowel permeability, Colonic inflammatory response, Small bowel inflammatory response
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gluten free dietOther
A 4-week gluten free diet provided
Gluten rich dietOther
A 4-week gluten rich diet is provided
| Study group | Role | What they receive |
|---|---|---|
| Gluten free diet | Experimental | Not described Receives: Other: Gluten free diet |
| Gluten rich diet | Experimental | Not described Receives: Other: Gluten rich diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Small bowel permeability
Excretion of mannitol 0-2 hours after liquid formulation
Measured: 0 - 2 hours post sugar ingestion
Colonic permeability
Cumulative excretion of mannitol at 2-24 hours after liquid
Measured: 2 -24 hours post sugars ingestion
Colonic transit
Colonic transit geometric center at 24 hours
Measured: 24 hours
Secondary outcomes (8)
Colon transit
Ascending colon emptying T1/2
Measured: 6-12 hours
Colonic permeability
Cumulative excretion of lactulose
Measured: 2-24 hours after sugars ingestion
Colonic permeability
Hourly excretion of mannitol
Measured: 8 to 24 hours after ingestion of sugars
Small bowel transit time
Colonic filling at 6 hours (%)
Measured: 6 hours
Gastric emptying
Gastric emptying T1/2
Measured: 0-2 hours
Colonic inflammatory response
Sigmoid colon mucosal immunocyte count in lamina propria
Measured: 4 weeks
Stool frequency and consistency
Bowel pattern diary
Measured: 6 weeks
Small bowel inflammatory response
Duodenal mucosal immunocyte count in lamina propria
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionJan 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Michael Camilleri, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01094041
- Sponsor's protocol ID
- 09-007344
- Status last verified
- May 2013
- First submitted
- 25 Mar 2010
- Last updated
- 10 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23357715
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gluten Intolerance in Irritable Bowel Syndrome With Diarrhea: The Role of HLA-DQ2
- ClinicalTrials.gov ID
- NCT01094041
- Acronym / sponsor ID
- 09-007344
- Keywords
- Gluten, Diarrhea or diarrhea predominant irritable bowel syndrome, Colonic permeability, Small bowel permeability, Colonic inflammatory response, Small bowel inflammatory response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 26 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gluten free diet | Experimental | Other: Gluten free diet |
| Gluten rich diet | Experimental | Other: Gluten rich diet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gluten free dietA 4-week gluten free diet provided | Other | Gluten free diet |
| Gluten rich dietA 4-week gluten rich diet is provided | Other | Gluten rich diet |
Primary outcome
Small bowel permeability
Time frame: 0 - 2 hours post sugar ingestion
Excretion of mannitol 0-2 hours after liquid formulation
Colonic permeability
Time frame: 2 -24 hours post sugars ingestion
Cumulative excretion of mannitol at 2-24 hours after liquid
Colonic transit
Time frame: 24 hours
Colonic transit geometric center at 24 hours
8 secondary outcomes
Colon transit
Time frame: 6-12 hours
Colonic permeability
Time frame: 2-24 hours after sugars ingestion
Colonic permeability
Time frame: 8 to 24 hours after ingestion of sugars
Small bowel transit time
Time frame: 6 hours
Gastric emptying
Time frame: 0-2 hours
Colonic inflammatory response
Time frame: 4 weeks
Stool frequency and consistency
Time frame: 6 weeks
Small bowel inflammatory response
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2013.
- Derived from this study: PubMed 23357715Vazquez-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.
Related trials for Diarrhea
Not yet recruiting
Comparison of Two Probiotics for Reducing Diarrhea Frequency in Children Aged 6-24 Months
Acute Watery Diarrhea, Acute Watery Diarrhoea
RecruitingPhase 2
Long-Term Immunogenicity of the altSonflex1-2-3 Shigella Vaccine in African Children
Diarrhoea
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
Recruiting
Lactic Acid Bacteria in Functional Diarrheal Disorders
IBS-D (Diarrhea-predominant), IBS (Irritable Bowel Syndrome)
RecruitingPhase 2
Prophylactic Mesalamine to Prevent Colitis Following Treatment With Ipilimumab/Nivolumab (Ipi/Nivo)
Immune-related Adverse Event, Diarrhea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Camilleri, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gluten free diet and Gluten rich diet in people with Diarrhea and Diarrhea Predominant Irritable Bowel Syndrome, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Small bowel permeability (time frame: 0 - 2 hours post sugar ingestion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01094041, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2013.