Pilot and Feasibility Study of 2'-FL as a Dietary Supplement in IBD Patients Receiving Stable Maintenance Anti-TNF Therapy
NCT ID: NCT03847467
Last Updated: 2025-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
116 participants
INTERVENTIONAL
2019-09-20
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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2'-Fucosyllactose
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)
2'-Fucosyllactose
Human milk oligosaccharide prebiotic dietary supplement
Placebo
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)
Placebo
Dextrose
Interventions
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2'-Fucosyllactose
Human milk oligosaccharide prebiotic dietary supplement
Placebo
Dextrose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 11 - 25
4. Diagnosed with Crohns Disease or Ulcerative Colitis
5. 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
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.
Exclusion Criteria
2. Use of any of the following medications during the previous month: antibiotics, probiotics or prebiotics
3. Diagnosis of celiac disease, diabetes or other co-morbidity that is determined by the PI as being exclusionary
4. Treatment with another investigational drug or other intervention within 4 weeks
5. Treatment with other biologic medication for IBD within prior 12 weeks
6. Problem with lactose breakdown
7. Currently pregnant or breast feeding
8. 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.
9. We will not allow concomitant use of anti-diarrheal medications.
11 Years
25 Years
ALL
No
Sponsors
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Broad Institute of MIT and Harvard
OTHER
University of Cincinnati
OTHER
Connecticut Children's Medical Center
OTHER
Nationwide Children's Hospital
OTHER
Children's Hospital Medical Center, Cincinnati
OTHER
Responsible Party
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Locations
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Connecticut Children's Medical Center
Hartford, Connecticut, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2017-6667
Identifier Type: -
Identifier Source: org_study_id
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