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

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ClinicalTrials.gov Identifier: NCT03582969
Recruitment Status : Recruiting
First Posted : July 11, 2018
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
Assaf Harofeh MC, Assaf-Harofeh Medical Center

Tracking Information
First Submitted Date  ICMJE June 28, 2018
First Posted Date  ICMJE July 11, 2018
Last Update Posted Date July 11, 2018
Estimated Study Start Date  ICMJE August 2018
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2018)
UC remission [ Time Frame: 12 weeks ]
UC remission at week 12 defined as a Simple Clinical Colitis Activity Index<3
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2018)
  • Improvement in UC symptoms [ Time Frame: 12 weeks ]
    defined as improvement in SCCAI
  • markers of inflammation [ Time Frame: 12 weeks, 6 months and 12 months ]
    Laboratory markers of inflammation - CRP, WBC, ANC, stool calprotectin
  • Improvement in UC endoscopic score [ Time Frame: 12 weeks, 6 months and 12 months ]
    Mayo-score
  • change in gut microbiome [ Time Frame: 12 weeks, 6 and 12 months. ]
    Diversity and variability of gut microbiome
  • use of treatments for UC [ Time Frame: 6+12 months ]
    such as glucocorticoids, immunosuppressive therapy (eg, azathioprine), or tumor necrosis factor antagonists.
  • Extra-intestinal disease manifestations [ Time Frame: 6 and 12 month ]
    Extra-intestinal disease manifestations
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Capsulized Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis Patients
Official Title  ICMJE 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
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This is a placebo-controlled, double blinded interventional study evaluating oral, fecal microbiota transplantation, administered in patients with mild-moderate UC.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
The placebo capsules are blocked capsules containing a mixture of saline and glycerine, identical in appearance and consistency to the FMT capsules.
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE
  • Other: Fecal transplantation
    Fecal transplantation administered orally via frozen capsules.
  • Other: Placebo
    Placebo capsules
Study Arms  ICMJE
  • Experimental: Fecal transplantation
    Fecal transplantation of feces from healthy donor via capsules. Oral application.
    Intervention: Other: Fecal transplantation
  • Placebo Comparator: Placebo
    Placebo capsules
    Intervention: Other: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 10, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ilan Youngster, MD 972-50-6301191 yongsteri@asaf.health.gov.il
Contact: Nirit Keren, PhD niritk@asaf.health.gov.il
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03582969
Other Study ID Numbers  ICMJE 0134-17-ASF
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Assaf Harofeh MC, Assaf-Harofeh Medical Center
Study Sponsor  ICMJE Assaf-Harofeh Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Assaf-Harofeh Medical Center
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP