Back to search results

2'-Fucosyllactose for Inflammatory Bowel Disease

This study is looking at whether a dietary supplement called 2'-fucosyllactose (2'-FL) can help young people with Inflammatory Bowel Disease (IBD), including Crohn's Disease and Ulcerative Colitis. You could join if you are 11 to 25 years old, have IBD, and your disease is currently in remission while you are taking anti-TNF medications like infliximab or adalimumab. Researchers want to see if 2'-FL can improve your gastrointestinal (GI) symptoms compared to a placebo (dextrose). The study is also looking at whether 2'-FL is safe and well-tolerated, and if it can increase certain helpful bacteria in your gut. The current status of this study is unclear.

Study design
This is a randomized, placebo-controlled study, meaning participants will be randomly assigned to receive either 2'-FL or a placebo. The study plans to enroll 116 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main study outcome will be measured at 20 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03847467

Pilot and Feasibility Study of 2'-FL as a Dietary Supplement in IBD Patients Receiving Stable Maintenance Anti-TNF Therapy

Completed
PHASE1Ages 11–25InterventionalTreatment
Children's Hospital Medical Center, Cincinnati
~128 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:2'-FucosyllactosePlacebo

At a glance

Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean Gastrointestinal Symptom Rating Scale (GSRS) in participants who receive 2'-fucosyllactose (2'FL) or dextrose placebo
Measured over 20 weeks

Conditions

Inflammatory Bowel Diseases
Crohn Disease
Ulcerative Colitis

Explore related trials

Crohn DiseaseUlcerative Colitis

Where it's being run

3 sites across 2 states
Ohio2
Connecticut1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Adult CD (age 18-25): CDAI score \< 150
Pediatric CD (age 11-17): wPCDAI \< 12.5
Adult UC (age 18-25): Modified Mayo sub-scores: stool frequency sub-score=0, rectal bleeding sub-score=0
Pediatric UC (age 11-17): PUCAI score \< 10 6. Not receiving corticosteroids 7. Receiving a stable anti-TNF maintenance dose of adalimumab, infliximab, or the biosimilar infliximab-dyyb for 12 weeks prior to enrollment. A stable infliximab or infliximab-dyyb dose may range from 5 mg/kg every 8 weeks to 10 mg/kg every 4 weeks. A stable adalimumab dose may range from 20 mg every 2 weeks to 40 mg every 7 days. While therapeutic drug monitoring will not be required for inclusion, all drug and anti-drug antibody levels obtained for clinical indications within six months prior to enrollment, and from the screening visit through week 20, will be recorded. 8. If receiving mesalamine, mercaptopurine, azathioprine, or methotrexate, must be on a stable dose for at least 12 weeks prior to enrollment. 9. Agreement to not make any major dietary changes throughout study duration. This would include changing usual diet to a vegan diet, Specific Carbohydrate Diet (SCD), or exclusive enteral nutrition (EEN) diet. 10. We will include CD patients who have had one ileo-colic resection, as long as the resection did not include more of the colon than the cecum and ascending colon. CD patients may be enrolled if at least six months post-surgery.

What this trial measures

  • Mean Gastrointestinal Symptom Rating Scale (GSRS) in participants who receive 2'-fucosyllactose (2'FL) or dextrose placebo20 weeks

    Measured by the Gastrointestinal Symptom Rating Scale (GSRS). The Gastrointestinal Symptom Rating Scale (GSRS) is a specific 15-item questionnaire for patients with GI symptoms. Patients are asked to numerically score their subjective symptoms on a scale of 1-7 (1=no discomfort up to 7=severe discomfort). The sum of the scores for all 15 items is regarded as the GSRS total score