2'-FL Supplement for Inflammatory Bowel Disease
(PRIME Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests 2'-FL, a sugar from breast milk, as a dietary supplement for young IBD patients in stable remission. It aims to boost good gut bacteria and improve gut health by increasing butyrate levels. 2'-FL, a human milk oligosaccharide, has been shown to promote the growth of beneficial gut bacteria and improve gut health in various studies.
Will I have to stop taking my current medications?
The trial requires that you stay on a stable dose of your current anti-TNF medication (like adalimumab or infliximab) for at least 12 weeks before joining. If you're taking mesalamine, mercaptopurine, azathioprine, or methotrexate, you must also be on a stable dose for 12 weeks before starting the trial. You cannot use antibiotics, probiotics, prebiotics, or anti-diarrheal medications during the trial.
Is 2'-FL safe for human consumption?
2'-Fucosyllactose (2'-FL) is considered safe for human consumption under the proposed conditions of use, as it is similar to natural components found in human milk. The European Food Safety Authority (EFSA) has evaluated its safety and found no concerns when used in foods and supplements, with intake levels comparable to those in breastfed infants.12345
How does the 2'-FL treatment differ from other treatments for inflammatory bowel disease?
The 2'-FL treatment is unique because it is a prebiotic oligosaccharide found in human milk that promotes the growth of beneficial gut bacteria and increases short-chain fatty acids like butyrate, which can improve gut health. Unlike traditional treatments that may focus on reducing inflammation directly, 2'-FL works by enhancing the gut microbiome, potentially leading to improved gastrointestinal symptoms and quality of life in patients with conditions like ulcerative colitis.16789
What data supports the effectiveness of the treatment 2'-Fucosyllactose for Inflammatory Bowel Disease?
Research shows that 2'-Fucosyllactose, a compound found in human milk, can help improve gut health by strengthening the intestinal barrier and reducing inflammation. Studies in mice with colitis, a type of inflammatory bowel disease, found that 2'-Fucosyllactose helped maintain body weight, protect colon length, and lower inflammation markers, suggesting it may be beneficial for similar conditions in humans.12101112
Are You a Good Fit for This Trial?
This trial is for young people aged 11-25 with Crohn's Disease or Ulcerative Colitis in remission, not on steroids, and taking stable anti-TNF therapy like adalimumab or infliximab. Participants must consent to the study rules and can't be pregnant, breastfeeding, have had recent surgery (except one ileo-colic resection), or been on certain medications.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 2'-FL or dextrose placebo as a daily dietary supplement
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- 2'-Fucosyllactose
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Hospital Medical Center, Cincinnati
Lead Sponsor
Nationwide Children's Hospital
Collaborator
Broad Institute of MIT and Harvard
Collaborator
Broad Institute
Collaborator
University of Cincinnati
Collaborator
Connecticut Children's Medical Center
Collaborator