RECRUITING

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

Conditions

Inflammatory Bowel Diseases Crohn Disease Ulcerative Colitis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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

Quick Facts

Study Start:2019-09-20

Study Completion:2027-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03847467

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:11 Years to 25 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Ramona Bezold, BSN

CONTACT

1-(513)-636-1412

Ramona.Bezold@cchmc.org

Study Locations (Sites)

Connecticut Children's Medical Center

Hartford, Connecticut, 06106

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

United States

Nationwide Children's Hospital

Columbus, Ohio, 43205

United States

Collaborators and Investigators

Sponsor: Children's Hospital Medical Center, Cincinnati

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-09-20

Study Completion Date2027-03

Study Record Updates

Study Start Date2019-09-20

Study Completion Date2027-03

Terms related to this study

Additional Relevant MeSH Terms

Inflammatory Bowel Diseases
Crohn Disease
Ulcerative Colitis