Capsulized Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis Patients (FMT UC)

July 10, 2018 updated by: Assaf Harofeh MC, Assaf-Harofeh Medical Center

High Intensity, Multi-Donor, Oral Capsulized Fecal Microbiota Transplantation in Newly Diagnosed Pediatric Patients With Mild to Moderate Ulcerative Colitis - a Double Blind, Placebo-Controlled Trial

Fecal Microbiota Transplantation(FMT) - reconstitution of normal flora by a stool transplant from a healthy individual, is increasingly being recognized as a therapeutic modality for diseases that are associated with gut dysbiosis.

This is a placebo-controlled, double blinded interventional study evaluating multiple, oral, fecal microbiota transplantation, administered in newly diagnosed pediatric patients with mild-moderate UC.

The primary objective is to assess the safety and feasibility of multiple, oral, fecal microbiota transplantation, in newly diagnosed pediatric patients with mild-moderate UC.

All processing will occur at the Center for Microbiome Research at Assaf Harofeh Medical Center, under GMP conditions.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Zerifin, Israel, 70300
        • Recruiting
        • Assaf-HarofehMC

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.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients newly diagnosed (>9 months) with mild to moderate ulcerative colitis as per colonic biopsy and clinical disease activity (SCCAI 5-12).
  • Patients not started on immune-suppressive or anti-inflammatory medications (Mesalamine is allowed).
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Women of childbearing potential will have a urine pregnancy test, which must be negative, on Study Day 1, prior to receiving FMT. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for 3 months after FMT.
  • Ability to understand and the willingness to sign a written document, including the willingness to accept risk of unrelated donor stool.
  • Ability of parents or other legal guardian to understand and the willingness to sign a written informed consent document, including the willingness to accept risk of unrelated donor stool.
  • Ability to swallow oral medications.

Exclusion Criteria:

  • Severe, uncontrolled ulcerative colitis.
  • At time of enrollment, immune-suppressive or anti-inflammatory medications, except Mesalamine.
  • Patients with active or uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
  • Delayed gastric emptying syndrome
  • Known chronic aspiration
  • Patients with a history of significant allergy to foods not excluded from the donor diet (excluded foods are tree nuts, peanuts, shellfish, eggs)
  • Pregnant and breast-feeding women
  • Participants who are unable to swallow pills.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo capsules
Other: Placebo
Placebo capsules
Experimental: Fecal transplantation
Fecal transplantation of feces from healthy donor via capsules. Oral application.
Other: Fecal transplantation
Fecal transplantation administered orally via frozen capsules.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
UC remission
Time Frame: 12 weeks
UC remission at week 12 defined as a Simple Clinical Colitis Activity Index<3
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in UC symptoms
Time Frame: 12 weeks
defined as improvement in SCCAI
12 weeks
Improvement in UC endoscopic score
Time Frame: 12 weeks, 6 months and 12 months
Mayo-score
12 weeks, 6 months and 12 months
markers of inflammation
Time Frame: 12 weeks, 6 months and 12 months
Laboratory markers of inflammation - CRP, WBC, ANC, stool calprotectin
12 weeks, 6 months and 12 months
change in gut microbiome
Time Frame: 12 weeks, 6 and 12 months.
Diversity and variability of gut microbiome
12 weeks, 6 and 12 months.
use of treatments for UC
Time Frame: 6+12 months
such as glucocorticoids, immunosuppressive therapy (eg, azathioprine), or tumor necrosis factor antagonists.
6+12 months
Extra-intestinal disease manifestations
Time Frame: 6 and 12 month
Extra-intestinal disease manifestations
6 and 12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assaf-Harofeh Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Anticipated)

August 1, 2018

Primary Completion (Anticipated)

July 1, 2021

Study Completion (Anticipated)

July 1, 2022

Study Registration Dates

First Submitted

June 28, 2018

First Submitted That Met QC Criteria

July 10, 2018

First Posted (Actual)

July 11, 2018

Study Record Updates

Last Update Posted (Actual)

July 11, 2018

Last Update Submitted That Met QC Criteria

July 10, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0134-17-ASF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Study Data/Documents

  1. Clinical Study Report

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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