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

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

Sponsors

Lead sponsor: Children's Hospital Medical Center, Cincinnati

Collaborator: Broad Institute
University of Cincinnati
Connecticut Children's Medical Center

Source Children's Hospital Medical Center, Cincinnati
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.

Overall Status Recruiting
Start Date September 20, 2019
Completion Date March 2023
Primary Completion Date March 2023
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Mean Gastrointestinal Symptom Rating Scale (GSRS) in participants who receive 2'-fucosyllactose (2'FL) or dextrose placebo 20 weeks
Secondary Outcome
Measure Time Frame
Mean fecal Bifidobacterium abundance in participants who receive 2'-fucosyllactose (2'FL) or dextrose placebo 20 weeks
Enrollment 216
Condition
Intervention

Intervention type: Drug

Intervention name: 2'-Fucosyllactose

Description: Human milk oligosaccharide prebiotic dietary supplement

Arm group label: 2'-Fucosyllactose

Other name: 2'-FL

Intervention type: Other

Intervention name: Placebo

Description: Dextrose

Arm group label: Placebo

Eligibility

Criteria:

Inclusion Criteria:

1. Provision of signed and dated informed consent form

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:

1. Experienced active IBD clinical disease during the previous six months as determined by the Principal Investigator.

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.

Gender: All

Minimum age: 11 Years

Maximum age: 25 Years

Healthy volunteers: No

Overall Contact

Last name: Ramona Bezold, BSN

Phone: 1-(513)-636-1412

Email: [email protected]

Location
facility status contact
Connecticut Children's Medical Center | Hartford, Connecticut, 06106, United States Recruiting Dena Hopkins, MPH 860-545-8125 [email protected]
Cincinnati Children's Hospital Medical Center | Cincinnati, Ohio, 45229, United States Recruiting Ramona Bezold, BSN 513-636-1412 [email protected]
Location Countries

United States

Verification Date

September 2019

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: 2'-Fucosyllactose

Arm group type: Experimental

Description: 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)

Arm group label: Placebo

Arm group type: Placebo Comparator

Description: 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)

Acronym PRIME
Study Design Info

Allocation: Randomized

Intervention model: Sequential Assignment

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov