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Synbiotics for Crohn's Disease
N/A
Waitlist Available
Led By Karen L Madsen, PhD
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-month period
Awards & highlights
Study Summary
This trial will assess whether a synbiotic therapy can prevent disease relapse in Crohn's Disease patients post-operatively.
Who is the study for?
This trial is for individuals with Crohn's disease who are about to have ileocolonic resection surgery. They must be able to use approved birth control if of childbearing potential and not be pregnant. Excluded are those with gluten or milk/soy allergies, psychological disorders, gut perforation/ischemia, severe diseases like AIDS or cancer, or on certain medications.Check my eligibility
What is being tested?
The study tests whether synbiotic therapy (probiotics plus dietary fiber) after surgery can prevent Crohn's disease relapse. Participants will take probiotics before and after surgery along with fiber supplements for six months while their health outcomes are monitored.See study design
What are the potential side effects?
Potential side effects may include digestive discomfort due to the introduction of new bacteria from probiotics and possible changes in bowel habits from increased fiber intake.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-month period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-month period
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The percentage of participants who experience treatment emergent adverse and serious adverse events
Secondary outcome measures
Changes in fecal bile acids
Changes in fecal short chain fatty acids
Changes in intestinal barrier function
+9 moreSide effects data
From 2020 Phase 2 trial • 20 Patients • NCT0212475914%
Vasovagal Syncope
14%
Nausea
14%
Abdominal Bloating/Flatulence
14%
Mouth Ulcers
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Sevelamer
Synbiotic
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SynbioticExperimental Treatment1 Intervention
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.
Group II: Digestible MaltodextrinPlacebo Group1 Intervention
Digestible maltodextrin will serve as the placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Synbiotic
2016
Completed Phase 3
~1290
Find a Location
Who is running the clinical trial?
University of AlbertaLead Sponsor
897 Previous Clinical Trials
387,159 Total Patients Enrolled
W. Garfield Weston FoundationUNKNOWN
2 Previous Clinical Trials
188 Total Patients Enrolled
Karen L Madsen, PhDPrincipal InvestigatorUniversity of Alberta
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Digestible Maltodextrin
- Group 2: Synbiotic
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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