Synbiotics and Post-op Crohn's Disease
Key facts
- Who runs it
- University of Alberta
- Where
- Canada5 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Terminated
- People taking part
- 4 people enrolled
- Started
- 15 Jul 2021
- Ended
- 31 Dec 2023
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Synbiotic
- Digestible Maltodextrin
- Record updated
- 19 January 2024
- Why it stopped
- Lack of funding
Who can take part
- Age
- 18 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- Diagnosis of Crohn's disease
- Undergoing ileocolonic resection
- Females of childbearing potential must agree to use a medically approved method of birth control (e.g. hormonal contraception, intrauterine devices, vasectomy/tubal ligation, barrier methods, double-barrier method) and must have negative pregnancy test results at screening and baseline
Who cannot take part
- Subjects unable to tolerate any oral intake following surgery
- Subjects with milk or soy allergy
- Subjects with diabetes, immune disorders, or bleeding disorders
- Subjects with any documented psychological disorders
- Subjects with perforation or ischemia of the gut
- Subjects with immune-compromised condition (e.g. AIDS, lymphoma)
- Subjects with uncontrolled cardiovascular or respiratory disease or active malignancy
- Subjects which are reliant on partial or total parenteral nutrition
- Subjects with permanent or temporary diverting ileostomies
- Subjects with gluten intolerance/sensitivity
- Pregnant women, women who are breast feeding, or women planning on becoming pregnant
- Subjects who are taking tetracycline
- Subjects who are enrolled in another clinical trial
- Subjects who are unable to give informed consent
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
Crohn's disease (CD) is a lifelong incurable condition that causes inflammation of the intestinal tract of humans. The exact cause of CD is unknown, but genetics, diet, and the gut microbiome are all thought to play a major role. Many patients with CD will require surgery to remove affected portions of the gut, with ileocecal resections being the most common procedure performed. Regrettably, there is up to an 85% chance that disease returns to the surgical site. Strong immune suppressive medications may help to prevent disease relapse. However, patients are then at risk of serious side effects. Currently, no ideal post-op care exists for CD patients.
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This study aims to assess whether a post-op synbiotic therapy (i.e. probiotics plus dietary fiber) prevents disease relapse in participants with CD. To test this, participants will consume probiotics (strains of bifidobacteria) before their surgery and then probiotics plus fiber supplements after surgery. Probiotics are live bacteria that have been shown to reduce inflammation of the gut. Fiber is given after surgery to help promote beneficial bacterial taxa and prevent less favorable bacterial taxa from triggering CD relapse. Patients will take the supplements for 6 months following surgery. They will be seen monthly to assess the effects of treatment on quality of life, symptoms of disease recurrence, inflammatory markers, and the gut microbiome. All patients will also undergo a colonoscopy at the end of the study to check for endoscopic reoccurrence.
The 2 groups in the trial
- SynbioticTreatment being tested
Bifidobacterium longum spp. longum R0175, Bifidobacterium animalis spp. Lafti B94, Bifidobacterium bifidum R0071 at 3x10\^9 CFU/d plus resistant starch type 2, arabinoxylan, and galactooligosaccharide at 24 g/d will serve as the treatment.
- Digestible MaltodextrinPlacebo, for comparison
Digestible maltodextrin will serve as the placebo.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Defining Microbial and Immune Changes Following Synbiotic Supplementation in Post-operative Crohn's Disease Patients
- Record updated
- 19 January 2024