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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)

Primary Purpose

Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

2'-Fucosyllactose

Placebo

About this trial

This is an interventional treatment trial for Inflammatory Bowel Diseases

Eligibility Criteria

11 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, aged 11 - 25
Diagnosed with Crohns Disease or Ulcerative Colitis
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
Not receiving corticosteroids
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.
If receiving mesalamine, mercaptopurine, azathioprine, or methotrexate, must be on a stable dose for at least 12 weeks prior to enrollment.
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.
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:

Experienced active IBD clinical disease during the previous six months as determined by the Principal Investigator.
Use of any of the following medications during the previous month: antibiotics, probiotics or prebiotics
Diagnosis of celiac disease, diabetes or other co-morbidity that is determined by the PI as being exclusionary
Treatment with another investigational drug or other intervention within 4 weeks
Treatment with other biologic medication for IBD within prior 12 weeks
Problem with lactose breakdown
Currently pregnant or breast feeding
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.
We will not allow concomitant use of anti-diarrheal medications.

Sites / Locations

Connecticut Children's Medical CenterRecruiting
Cincinnati Children's Hospital Medical CenterRecruiting
Nationwide Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

2'-Fucosyllactose

Placebo

Arm 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)

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)

Outcomes

Primary Outcome Measures

Mean Gastrointestinal Symptom Rating Scale (GSRS) in participants who receive 2'-fucosyllactose (2'FL) or dextrose placebo

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

Mean fecal Bifidobacterium abundance in participants who receive 2'-fucosyllactose (2'FL) or dextrose placebo

Measured by fecal DNA 16S ribosomal sequencing

Full Information

NCT ID

NCT03847467

First Posted

February 12, 2019

Last Updated

October 5, 2023

Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

Broad Institute, University of Cincinnati, Connecticut Children's Medical Center, Nationwide Children's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03847467

Brief Title

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

Acronym

PRIME

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 20, 2019 (Actual)

Primary Completion Date

March 2026 (Anticipated)

Study Completion Date

March 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

Broad Institute, University of Cincinnati, Connecticut Children's Medical Center, Nationwide Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Sequential Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

216 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

2'-Fucosyllactose

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

2'-Fucosyllactose

Other Intervention Name(s)

2'-FL

Intervention Description

Human milk oligosaccharide prebiotic dietary supplement

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Dextrose

Primary Outcome Measure Information:

Title

Mean Gastrointestinal Symptom Rating Scale (GSRS) in participants who receive 2'-fucosyllactose (2'FL) or dextrose placebo

Description

Time Frame

20 weeks

Secondary Outcome Measure Information:

Title

Mean fecal Bifidobacterium abundance in participants who receive 2'-fucosyllactose (2'FL) or dextrose placebo

Description

Measured by fecal DNA 16S ribosomal sequencing

Time Frame

20 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

11 Years

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Male or female, aged 11 - 25 Diagnosed with Crohns Disease or Ulcerative Colitis 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 Not receiving corticosteroids 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. If receiving mesalamine, mercaptopurine, azathioprine, or methotrexate, must be on a stable dose for at least 12 weeks prior to enrollment. 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. 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: Experienced active IBD clinical disease during the previous six months as determined by the Principal Investigator. Use of any of the following medications during the previous month: antibiotics, probiotics or prebiotics Diagnosis of celiac disease, diabetes or other co-morbidity that is determined by the PI as being exclusionary Treatment with another investigational drug or other intervention within 4 weeks Treatment with other biologic medication for IBD within prior 12 weeks Problem with lactose breakdown Currently pregnant or breast feeding 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. We will not allow concomitant use of anti-diarrheal medications.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ramona Bezold, BSN

Phone

1-(513)-636-1412

Ramona.Bezold@cchmc.org

Facility Information:

Facility Name

Connecticut Children's Medical Center

City

Hartford

State/Province

Connecticut

ZIP/Postal Code

06106

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dena Hopkins, MPH

Phone

860-545-8125

DHopkins01@connecticutchildrens.org

Facility Name

Cincinnati Children's Hospital Medical Center

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45229

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ramona Bezold, BSN

Phone

513-636-1412

Ramona.Bezold@cchmc.org

Facility Name

Nationwide Children's Hospital

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43205

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jennifer Dotson, MD

Jennifer.Dotson@nationwidechildrens.org

First Name & Middle Initial & Last Name & Degree

Jennifer Dotson, MD

12. IPD Sharing Statement

Learn more about this trial

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

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