Gastrointestinal DisordersNCT02098057
Change in Permeability of the Small Intestine After Treatment With Gluten
A study testing Gluten Healthy in people with Gastrointestinal Disorders, run by Mayo Clinic at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Disorders
- What is being tested?
- Gluten Healthy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to 19 Sep 2016
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non celiac gluten sensitive patients with a functional bowel disorder
- Age 18 to 70 years.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study Barrier Function, Intestinal Permeability and Tight Junction Expression in Gluten Sensitive Patients With Functional Gastrointestinal Disorders
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).
Read the detailed description
The specific aim of this hypothesis-generating, pilot study is to randomize (like the flip of a coin) patients who have Non Celiac Gluten Sensitivity to a 4-week Gluten-containing diet (GCD) or to a Gluten free diet (GFD). The study will evaluate small bowel (SB) permeability functionally (2-sugar differential excretion), morphologically, using probe-based confocal laser to evaluate the small intestinal, as well as molecularly, using tight junction (TJ) messenger RNA (mRNA) expression in small bowel mucosa in response to the different diets.
- Conditions
- Gastrointestinal Disorders
- Being tested
- Gluten Healthy, Placebo
- Keywords
- IBS-diarrhea
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: Gluten Healthy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in permeability of the small intestine after treatment
Measured: Baseline to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Study startApr 2014
- Primary completion19 Sep 2016
- Study completion19 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DisordersStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria I. Vazquez Roque, M.D., Mayo Clinic
- Investigators
- Maria I Vazquez Roque, MD, MSc, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02098057
- Sponsor's protocol ID
- 13-005160
- Other IDs
- FP00074933
- Status last verified
- Apr 2019
- First submitted
- 14 Mar 2014
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Barrier Function, Intestinal Permeability and Tight Junction Expression in Gluten Sensitive Patients With Functional Gastrointestinal Disorders
- ClinicalTrials.gov ID
- NCT02098057
- Acronym / sponsor ID
- 13-005160
- Conditions
- Gastrointestinal Disorders
- Keywords
- IBS-diarrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- 19 Sep 2016 (actual)
- Study completion
- 19 Sep 2016 (actual)
- First posted
- 27 Mar 2014 (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 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).
Detailed description
The specific aim of this hypothesis-generating, pilot study is to randomize (like the flip of a coin) patients who have Non Celiac Gluten Sensitivity to a 4-week Gluten-containing diet (GCD) or to a Gluten free diet (GFD). The study will evaluate small bowel (SB) permeability functionally (2-sugar differential excretion), morphologically, using probe-based confocal laser to evaluate the small intestinal, as well as molecularly, using tight junction (TJ) messenger RNA (mRNA) expression in small bowel mucosa in response to the different diets.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboA 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 |
| Gluten | Active comparator | Dietary Supplement: Gluten HealthyA 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Non celiac gluten sensitive patients with a functional bowel disorder
- Age 18 to 70 years.
Key exclusion criteria (9 listed)
- 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.
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 HealthyAssessment 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. | Dietary supplement | Gluten |
| PlaceboA 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. | Drug | Placebo |
Primary outcome
Change in permeability of the small intestine after treatment
Time frame: Baseline to 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 8 Apr 2019.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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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.
Maria I Vazquez Roque, MD, MSc 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 Healthy in people with Gastrointestinal Disorders, 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 2 inclusion and 9 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 8 Apr 2019. 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. Some participants in this study may receive a placebo. 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?
Change in permeability of the small intestine after treatment (time frame: Baseline to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2019.