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

NCT03847467 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 2017-6667
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 3

Brief Summary

Randomized, placebo-controlled dose-ranging study of 2'-FL in IBD, Crohn's Disease (CD) and ulcerative colitis (UC). The overarching hypothesis is that 2'-FL supplementation in IBD will be safe and well tolerated, while increasing fecal Bifidobacterium abundance and butyrate in a dose dependent manner. The investigators will test 1, 5, or 10 gm 2'-FL compared to 2 gm dextrose placebo as a daily dietary supplement in pediatric and young adult IBD participants in stable remission receiving infliximab, adalimumab, or infliximab-dyyb biosimilar anti-TNF therapy.

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

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

  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

  20 weeks

Secondary Outcomes (1)

• Mean fecal Bifidobacterium abundance in participants who receive 2'-fucosyllactose (2'FL) or dextrose placebo

  20 weeks

Study Arms (2)

2'-Fucosyllactose

EXPERIMENTAL

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)

Drug: 2'-Fucosyllactose

Placebo

PLACEBO COMPARATOR

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)

Other: Placebo

Interventions

2'-Fucosyllactose DRUG

Human milk oligosaccharide prebiotic dietary supplement

Also known as: 2'-FL

2'-Fucosyllactose

Placebo OTHER

Dextrose

Placebo

Eligibility Criteria

• Age: 11 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged 11 - 25
• Diagnosed with Crohns Disease or Ulcerative Colitis
• Disease is in remission
• 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
• Not receiving corticosteroids
• If receiving mesalamine, mercaptopurine, azathioprine, or methotrexate, must be on a stable dose for at least 12 weeks prior to enrollment.
• 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.
• 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.

You may not qualify if:

• Experienced active IBD clinical disease during the previous six months as determined by the Principal Investigator.
• Use of any of the following medications during the previous month: antibiotics, probiotics or prebiotics
• Treatment with another investigational drug or other intervention within 4 weeks
• Treatment with other biologic medication for IBD within prior 12 weeks
• Problem with lactose breakdown
• Currently pregnant or breast feeding
• We will exclude CD patients with more than one IBD related surgery, or those with a sub-total colectomy. We will exclude UC patients with colectomy or IBD related surgery.
• We will not allow concomitant use of anti-diarrheal medications.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Broad Institute of MIT and Harvard: collaborator
• University of Cincinnati: collaborator
• Connecticut Children's Medical Center: collaborator
• Nationwide Children's Hospital: collaborator

Study Sites (3)

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Interventions

2'-fucosyllactose

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Central Study Contacts

Ramona Bezold, BSN

CONTACT

1-(513)-636-1412; Ramona.Bezold@cchmc.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: February 20, 2019
• Study Start: September 20, 2019
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)