NCT03950336Completed
Prebiotics and Diet to Reduce "Leaky" Gut in First Degree Relatives of Crohn's Disease Patients
Influence of Prebiotics on Intestinal Permeability in First Degree Relatives of Crohn's Patients
Source: ClinicalTrials.gov · Last updated 20 May 2024
Brief summary (registry, in English)
Crohn's disease (CD) is a recurring inflammation of the intestines. The etiology is unknown; however evidence suggests that it could be a combination of gut microbes, environmental factors and genetics. CD has a strong genetic component, with up to 12% of patients having familial history. The Western diet is also thought to increase the risk of developing CD. In addition up to 20% of healthy first-degree relatives (FRD) of CD patients have increased small intestinal permeability ("leaky gut"). Previous studies have also shown that the Western diet can affect the intestinal immune response and normal intestinal barrier function, as well as alter the gut microbiota. We are interested in looking into whether beneficial dietary fibers (prebiotics) in combination with a diet low in n-6 polyunsaturated fatty acids (PUFAs) and high in n-3 PUFAs can protect against the development of CD. Prebiotics are carbohydrates that cannot be digested by human enzymes and instead feed the bacteria in the colon that can digest them. Prebiotics occur in different fruits and vegetables. They have been shown to improve health by positively changing the gut microbes and their metabolism. The prebiotic we will be using are β-fructans. β-fructans have been shown to reduce "leaky gut" and positively impact the intestinal immune system in experimental models and healthy humans. Diet has been shown to affect the gut microbes, intestinal inflammation development and the activity of prebiotics. We hypothesize that β-fructans in combination with a diet low in n-6 PUFAs / high in n-3 PUFAs (similar to a Mediterranean diet) can reduce intestinal permeability ("leaky gut") in FDR of CD patients, associated with beneficial changes in the gut microbes. Participants (FDR of CD patients; 40 total) will be randomized and receive either a 12 g/day dose of the prebiotic oligofructose-enriched inulin (Prebiotin), or placebo (maltodextrin), as well as a dietary intervention. In order to control the n-3 and n-6 PUFA intake, participants will receive nutritional counselling by a registered dietitian. The Mediterranean diet will have the low n-6 and high n-3 intake ("Low n-6 PUFA"). Participants in the control diet group will be advised to follow the Canada's Food Guide (CFG) recommendations. Thus, this placebo-controlled study will involve 2 intervention groups with 20 participants in each group: 1) Prebiotic + Low n-6 PUFA; 2) Placebo + CFG.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 33 (actual)
- First submitted
- 13 May 2019
- Start date
- 4 Feb 2020
- Primary completion date
- 8 Jan 2024
- Lead sponsor
- University of Alberta
- Diseases
- Crohn's disease
- NCT number
- NCT03950336
What you commit to
- Study type: Interventional
- Participants enrolled: 33
- From 4 Feb 2020 to the primary completion date, 8 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Alcohol or drug abuse;
Other illness
- Celiac disease (allergic reaction to wheat products), gluten intolerance/sensitivity;
- Having history or evidence of significant gastrointestinal dysfunction and Irritable Bowel Syndrome (IBS);
- Having an active gastrointestinal infection (confirmed by stool pathogen culture test and Clostridioides difficile test)
- Having history or evidence of blood and bleeding disorder;
- Having a significant chronic disorder such as immune disorders, organ transplant, severe cardiac disease, renal failure, severe pulmonary disease, severe psychiatric disorder;
Lab values
- Diabetes or uncontrolled / unstable blood glucose levels;
Other
- Use of probiotic and prebiotic supplements, fish oil or NSAIDS, prescribed or over the counter in the last 1 week;
- Use of antibiotics in the last 2 months;
- Having uncontrolled or unstable blood pressure;
- Pregnant or lactating;
- Not able to consent to the study.
Who the study is looking for
- Males and females aged 15 - 50;
- First degree relative (parent, sibling, child) of patient diagnosed with Crohn's disease;
- Agree not to use any dietary supplements, herbal treatments, probiotics, prebiotics or dietary therapies within 1 week of starting the trial and during the study;
- Willingness to keep current physical activity during study period;
- Ability to give valid informed consent
- For females of childbearing potential and sexually active, a negative pregnancy test at screening, baseline and end-of-study, and accord to use appropriate birth control method (hormonal contraceptives, intrauterine devices, vasectomy/tubal ligation, barrier methods (condom or diaphragm), double-barrier methods or abstinence) during study period.
Age in the registry: 15 years to 50 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alberta Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.