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

Who is this study for? Child to young adult patients with Crohn's Disease or Ulcerative Colitis
What treatments are being studied? 2'-Fucosyllactose
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 11
Maximum Age: 25
Healthy Volunteers: f
View:

• 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

• 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.

• 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.

Locations
United States
Connecticut
Connecticut Children's Medical Center
RECRUITING
Hartford
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Nationwide Children's Hospital
RECRUITING
Columbus
Contact Information
Primary
Ramona Bezold, BSN
Ramona.Bezold@cchmc.org
1-(513)-636-1412
Time Frame
Start Date: 2019-09-20
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 116
Treatments
Experimental: 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)
Placebo_comparator: 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)
Sponsors
Collaborators: Broad Institute of MIT and Harvard, Nationwide Children's Hospital, University of Cincinnati, Connecticut Children's Medical Center
Leads: Children's Hospital Medical Center, Cincinnati

This content was sourced from clinicaltrials.gov