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2'-FL Supplement for Inflammatory Bowel Disease (PRIME Trial)

Phase 1 & 2
Recruiting
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pediatric CD (age 11-17): wPCDAI < 12.5
Adult CD (age 18-25): CDAI score < 150
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 weeks
Awards & highlights

PRIME Trial Summary

This trial is testing whether a supplement called 2'-FL is safe and effective in treating inflammatory bowel diseases like Crohn's Disease and ulcerative colitis. 1, 5, or 10 gm of 2'-FL will be given daily compared to a placebo to see if it increases the abundance of good bacteria and butyrate in the gut.

Who is the study for?
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.Check my eligibility
What is being tested?
The study tests if a dietary supplement called 2'-Fucosyllactose (2'-FL) at doses of 1, 5, or 10 grams daily is safe and improves gut health compared to a placebo in those with IBD. It's randomized so participants don't choose which treatment they get.See study design
What are the potential side effects?
Since this is testing a dietary supplement expected to improve gut bacteria levels safely, major side effects are not anticipated. However, any potential digestive discomfort will be monitored as part of the trial's safety assessment.

PRIME Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My child's Crohn's disease is mild.
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I am 18-25 years old with mild Crohn's disease symptoms.
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I have been diagnosed with Crohn's Disease or Ulcerative Colitis.
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I am between 11 and 25 years old.
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I have been on a consistent dose of anti-TNF medication for 12 weeks.
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My condition is currently in remission.
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I am not taking corticosteroids.
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I am an adult with UC and currently have no blood in stool or increased stool frequency.
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I have Crohn's disease, had one surgery removing part of my small intestine and colon, and it's been 6 months since.
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I have been on a stable dose of specific medications for at least 12 weeks.
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I am aged 11-17 with mild ulcerative colitis symptoms.

PRIME Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Gastrointestinal Symptom Rating Scale (GSRS) in participants who receive 2'-fucosyllactose (2'FL) or dextrose placebo
Secondary outcome measures
Glucose

PRIME Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: 2'-FucosyllactoseExperimental Treatment1 Intervention
Phase I: 36 young adult participants aged 18-25 years. Group 1: 1 gm per day n=12 (6UC/6CD) Group 2: 5 gm per day n=12 (6UC/6CD) Group 3: 10 gm per day n=12 (6UC/6CD) Phase II (post Phase I interim safety analysis): 120 participants aged 11-25 years Group 1: 1 gm per day n=40 (20UC/20CD) Group 2: 5 gm per day n=40 (20UC/20CD) Group 3: 10 gm per day n=40 (20UC/20CD)
Group II: PlaceboPlacebo Group1 Intervention
Phase I: 20 young adult participants age 18-25 years dosed at 2 gm placebo per day. (10UC/10CD) Phase II (post Phase I interim safety analysis): 40 participants age 11-25 years dosed at 2 gm placebo per day. (20UC/20CD)

Find a Location

Who is running the clinical trial?

Nationwide Children's HospitalOTHER
338 Previous Clinical Trials
5,219,930 Total Patients Enrolled
Broad InstituteOTHER
19 Previous Clinical Trials
16,061 Total Patients Enrolled
University of CincinnatiOTHER
427 Previous Clinical Trials
634,155 Total Patients Enrolled

Media Library

2'-Fucosyllactose Clinical Trial Eligibility Overview. Trial Name: NCT03847467 — Phase 1 & 2
Inflammatory Bowel Disease Research Study Groups: Placebo, 2'-Fucosyllactose
Inflammatory Bowel Disease Clinical Trial 2023: 2'-Fucosyllactose Highlights & Side Effects. Trial Name: NCT03847467 — Phase 1 & 2
2'-Fucosyllactose 2023 Treatment Timeline for Medical Study. Trial Name: NCT03847467 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there openings for potential participants in this experiment?

"That is correct. According to the information on clinicaltrials.gov, this trial continues to search for participants and was initially posted in September 2019. It has since been updated as recently as January 2022, recruiting a total of 216 patients at three different sites."

Answered by AI

Have any other investigations delved into the potential of 2'-Fucosyllactose?

"Currently, two studies exploring the efficacy of 2'-Fucosyllactose are underway. Neither study has reached phase 3 yet; however, several trials are occurring in Cincinnati and a total of four sites are involved with these research projects."

Answered by AI

Is it possible to register for this research trial?

"This clinical trial is open to 216 individuals afflicted with ileocolitis between the ages of 11 and 25. The important requirements for applicants are: willingness to comply, CDAI score (if aged 18-25), signed informed consent form, gender identification, remission status from Crohn's disease or Ulcerative colitis (depending on age group), wPCDAI sub-score (for those aged 11-17) and PUCAI score if under 17 as well as no current steroid use."

Answered by AI

To what extent has this medical research been populated with participants?

"Affirmative. The particulars on clinicaltrials.gov demonstrate that this experiment, established on September 20th 2019, is currently seeking volunteers. A total of 216 subjects are expected to be recruited from 3 sites."

Answered by AI

Is this research available to those under the age of sixty?

"Qualified candidates for this trial ought to be between eleven and twenty-five years of age. In comparison, there are 119 trials catered towards those under eighteen while 386 studies serve patients above 65 years old."

Answered by AI
~65 spots leftby Mar 2026