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Trial record 5 of 14 for:    dysbiosis | Recruiting Studies | fecal microbiota transplantation

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

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.


Condition or disease Intervention/treatment Phase
Ulcerative Colitis Other: Fecal transplantation Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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
Official Title: 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
Estimated Study Start Date : August 2018
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2022


Arm Intervention/treatment
Experimental: Fecal transplantation
Fecal transplantation of feces from healthy donor via capsules. Oral application.
Other: Fecal transplantation
Fecal transplantation administered orally via frozen capsules.

Placebo Comparator: Placebo
Placebo capsules
Other: Placebo
Placebo capsules




Primary Outcome Measures :
  1. UC remission [ Time Frame: 12 weeks ]
    UC remission at week 12 defined as a Simple Clinical Colitis Activity Index<3


Secondary Outcome Measures :
  1. Improvement in UC symptoms [ Time Frame: 12 weeks ]
    defined as improvement in SCCAI

  2. markers of inflammation [ Time Frame: 12 weeks, 6 months and 12 months ]
    Laboratory markers of inflammation - CRP, WBC, ANC, stool calprotectin

  3. Improvement in UC endoscopic score [ Time Frame: 12 weeks, 6 months and 12 months ]
    Mayo-score

  4. change in gut microbiome [ Time Frame: 12 weeks, 6 and 12 months. ]
    Diversity and variability of gut microbiome

  5. use of treatments for UC [ Time Frame: 6+12 months ]
    such as glucocorticoids, immunosuppressive therapy (eg, azathioprine), or tumor necrosis factor antagonists.

  6. Extra-intestinal disease manifestations [ Time Frame: 6 and 12 month ]
    Extra-intestinal disease manifestations



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT03582969


Contacts
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Contact: Ilan Youngster, MD 972-50-6301191 yongsteri@asaf.health.gov.il
Contact: Nirit Keren, PhD niritk@asaf.health.gov.il

Locations
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Israel
Assaf-HarofehMC Recruiting
Zerifin, Israel, 70300
Contact: Ilan Youngster, Dr.    972-50-6301191    youngsteri@asaf.health.gov.il   
Sponsors and Collaborators
Assaf-Harofeh Medical Center

Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site

Publications:

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Responsible Party: Assaf Harofeh MC, Dr. Ilan Youngster, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT03582969     History of Changes
Other Study ID Numbers: 0134-17-ASF
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assaf Harofeh MC, Assaf-Harofeh Medical Center:
IBD
UC
fecal-transplantation
capsules
microbiota
microbiome
colitis
pediatric
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases