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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03847467
Recruitment Status : Recruiting
First Posted : February 20, 2019
Last Update Posted : February 1, 2022
Sponsor:
Collaborators:
Broad Institute
University of Cincinnati
Connecticut Children's Medical Center
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Crohn Disease Ulcerative Colitis Drug: 2'-Fucosyllactose Other: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 20, 2019
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)

Drug: 2'-Fucosyllactose
Human milk oligosaccharide prebiotic dietary supplement
Other Name: 2'-FL

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)

Other: Placebo
Dextrose




Primary Outcome Measures :
  1. Mean Gastrointestinal Symptom Rating Scale (GSRS) in participants who receive 2'-fucosyllactose (2'FL) or dextrose placebo [ Time Frame: 20 weeks ]
    Measured by the Gastrointestinal Symptom Rating Scale (GSRS). The Gastrointestinal Symptom Rating Scale (GSRS) is a specific 15-item questionnaire for patients with GI symptoms. Patients are asked to numerically score their subjective symptoms on a scale of 1-7 (1=no discomfort up to 7=severe discomfort). The sum of the scores for all 15 items is regarded as the GSRS total score


Secondary Outcome Measures :
  1. Mean fecal Bifidobacterium abundance in participants who receive 2'-fucosyllactose (2'FL) or dextrose placebo [ Time Frame: 20 weeks ]
    Measured by fecal DNA 16S ribosomal sequencing



Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03847467


Contacts
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Contact: Ramona Bezold, BSN 1-(513)-636-1412 Ramona.Bezold@cchmc.org

Locations
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United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: Dena Hopkins, MPH    860-545-8125    DHopkins01@connecticutchildrens.org   
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Ramona Bezold, BSN    513-636-1412    Ramona.Bezold@cchmc.org   
Nationwide Children's Hospital Not yet recruiting
Columbus, Ohio, United States, 43205
Contact: Jennifer Dotson, MD       Jennifer.Dotson@nationwidechildrens.org   
Principal Investigator: Jennifer Dotson, MD         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Broad Institute
University of Cincinnati
Connecticut Children's Medical Center
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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT03847467    
Other Study ID Numbers: 2017-6667
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: February 1, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases