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



Status:Not yet recruiting
Conditions:Colitis, Irritable Bowel Syndrome (IBS), Gastrointestinal, Gastrointestinal, Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:11 - 25
Updated:2/22/2019
Start Date:March 2019
End Date:March 2023
Contact:Ramona Bezold, BSN
Email:Ramona.Bezold@cchmc.org
Phone:1-(513)-636-1412

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

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.


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.
We found this trial at
2
sites
282 Washington St
Hartford, Connecticut 06106
(860) 545-9000
Phone: 860-545-8125
Connecticut Children's Medical Center Connecticut Children’s Medical Center is a nationally recognized, 187-bed not-for-profit children’s...
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Phone: 513-636-1412
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Cincinnati, OH
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