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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 October 2023
• Main ID: NCT03847467
• Date of registration: 12/02/2019
• Prospective Registration: Yes
• Primary sponsor: Children's Hospital Medical Center, Cincinnati
• Public title: Pilot and Feasibility Study of 2'-FL as a Dietary Supplement in IBD Patients Receiving Stable Maintenance Anti-TNF Therapy PRIME
• Scientific title: Pilot and Feasibility Study of 2'-FL as a Dietary Supplement in Pediatric and Young Adult IBD Patients Receiving Stable Maintenance Anti-TNF Therapy
• Date of first enrolment: September 20, 2019
• Target sample size: 216
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03847467
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Contacts

• Name: Ramona Bezold, BSN

Key inclusion & exclusion 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.



Age minimum: 11 Years
Age maximum: 25 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn Disease

Inflammatory Bowel Diseases

Ulcerative Colitis

Intervention(s)

Drug: 2'-Fucosyllactose

Other: Placebo

Primary Outcome(s)

Mean Gastrointestinal Symptom Rating Scale (GSRS) in participants who receive 2'-fucosyllactose (2'FL) or dextrose placebo [Time Frame: 20 weeks]

Secondary Outcome(s)

Mean fecal Bifidobacterium abundance in participants who receive 2'-fucosyllactose (2'FL) or dextrose placebo [Time Frame: 20 weeks]

Secondary ID(s)

2017-6667

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Connecticut Children's Medical Center

University of Cincinnati

Broad Institute

Nationwide Children's Hospital