Actively Recruiting
Pilot and Feasibility Study of 2'-FL as a Dietary Supplement in IBD Patients Receiving Stable Maintenance Anti-TNF Therapy
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2025-06-12
116
Participants Needed
3
Research Sites
405 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital Medical Center, Cincinnati
Lead Sponsor
B
Broad Institute of MIT and Harvard
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Pilot and Feasibility Study of 2'-FL as a Dietary Supplement in IBD Patients Receiving Stable Maintenance Anti-TNF Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form provided
- Willingness to comply with all study procedures and availability for the study duration
- Male or female aged 11 to 25 years
- Diagnosed with Crohn's Disease or Ulcerative Colitis
- Disease is in remission with specific clinical scores below thresholds
- Not receiving corticosteroids
- On stable anti-TNF maintenance therapy (adalimumab, infliximab, or infliximab-dyyb) for at least 12 weeks prior to enrollment
- Stable dose of mesalamine, mercaptopurine, azathioprine, or methotrexate for at least 12 weeks if applicable
- Agreement to avoid major dietary changes during the study
- Crohn's Disease patients may have had one ileo-colic resection at least six months prior, without extensive colon removal
You will not qualify if you...
- Active IBD symptoms in the previous six months
- Use of antibiotics, probiotics, or prebiotics in the previous month
- Diagnosis of celiac disease, diabetes, or other significant co-morbidities
- Treatment with another investigational drug or intervention within four weeks
- Use of other biologic medications for IBD within the prior 12 weeks
- Lactose intolerance
- Currently pregnant or breastfeeding
- Crohn's Disease patients with more than one IBD-related surgery or sub-total colectomy
- Ulcerative Colitis patients with colectomy or IBD-related surgery
- Use of anti-diarrheal medications during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
Actively Recruiting
2
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
3
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
Research Team
R
Ramona Bezold, BSN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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