Capsulized Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis Patients

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 12 Years - 18 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03582969
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Assaf-Harofeh Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Israel
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Ulcerative Colitis
Arms & Interventions

Arms

Experimental: Fecal transplantation

Fecal transplantation of feces from healthy donor via capsules. Oral application.

Placebo Comparator: Placebo

Placebo capsules

Interventions

Other: - Fecal transplantation

Fecal transplantation administered orally via frozen capsules.

Other: - Placebo

Placebo capsules

Contact a Trial Team

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International Sites

Assaf-HarofehMC, Zerifin, Israel

Status

Recruiting

Address

Assaf-HarofehMC

Zerifin, , 70300

Site Contact

Ilan Youngster, Dr.

youngsteri@asaf.health.gov.il

972-50-6301191

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