Prebiotics and Diet to Reduce "Leaky" Gut in First Degree Relatives of Crohn's Disease Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 5 February 2024
• Main ID: NCT03950336
• Date of registration: 13/05/2019
• Prospective Registration: Yes
• Primary sponsor: University of Alberta
• Public title: Prebiotics and Diet to Reduce "Leaky" Gut in First Degree Relatives of Crohn's Disease Patients
• Scientific title: Influence of Prebiotics on Intestinal Permeability in First Degree Relatives of Crohn's Patients
• Date of first enrolment: February 4, 2020
• Target sample size: 33
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03950336
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Double (Participant, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: Levinus Dieleman, MD, PhD
• Affiliation: University of Alberta

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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;

- Celiac disease (allergic reaction to wheat products), gluten intolerance/sensitivity;

- Diabetes or uncontrolled / unstable blood glucose levels;

- 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 uncontrolled or unstable blood pressure;

- Having a significant chronic disorder such as immune disorders, organ transplant,
severe cardiac disease, renal failure, severe pulmonary disease, severe psychiatric
disorder;

- Alcohol or drug abuse;

- Pregnant or lactating;

- Not able to consent to the study.



Age minimum: 15 Years
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

Healthy First Degree Relatives of Crohn's Disease Patients

Intervention(s)

Dietary Supplement: Maltodextrin

Other: Low n-6 PUFA Diet

Dietary Supplement: Prebiotics

Other: Control Diet

Primary Outcome(s)

Change in small intestinal permeability over 6 weeks [Time Frame: week 0 and week 6]

Secondary Outcome(s)

Changes in fecal microbiota and their metabolic activity [Time Frame: weeks 0 and 6]

Changes in serum/plasma markers for intestinal permeability [Time Frame: weeks 0 and 6]

Participant compliance and tolerability [Time Frame: weeks 0, 3 and 6]

Secondary ID(s)

Pro00090125

Source(s) of Monetary Support

Please refer to primary and secondary sponsors