Back to results

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

Primary Purpose

Ulcerative Colitis

Status

Unknown status

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

Fecal transplantation

Placebo

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring IBD, UC, fecal-transplantation, capsules, microbiota, microbiome, colitis, pediatric

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Assaf-HarofehMCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fecal transplantation

Placebo

Arm Description

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

Placebo capsules

Outcomes

Primary Outcome Measures

UC remission

UC remission at week 12 defined as a Simple Clinical Colitis Activity Index<3

Secondary Outcome Measures

Improvement in UC symptoms

defined as improvement in SCCAI

markers of inflammation

Laboratory markers of inflammation - CRP, WBC, ANC, stool calprotectin

Improvement in UC endoscopic score

Mayo-score

change in gut microbiome

Diversity and variability of gut microbiome

use of treatments for UC

such as glucocorticoids, immunosuppressive therapy (eg, azathioprine), or tumor necrosis factor antagonists.

Extra-intestinal disease manifestations

Full Information

NCT ID

NCT03582969

First Posted

June 28, 2018

Last Updated

July 10, 2018

Sponsor

Assaf-Harofeh Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03582969

Brief Title

Capsulized Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis Patients

Acronym

FMT UC

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Unknown status

Study Start Date

August 2018 (Anticipated)

Primary Completion Date

July 2021 (Anticipated)

Study Completion Date

July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assaf-Harofeh Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

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

Ulcerative Colitis

Keywords

IBD, UC, fecal-transplantation, capsules, microbiota, microbiome, colitis, pediatric

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantCare ProviderInvestigator

Masking Description

The placebo capsules are blocked capsules containing a mixture of saline and glycerine, identical in appearance and consistency to the FMT capsules.

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Fecal transplantation

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo capsules

Intervention Type

Other

Intervention Name(s)

Fecal transplantation

Intervention Description

Fecal transplantation administered orally via frozen capsules.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo capsules

Primary Outcome Measure Information:

Title

UC remission

Description

UC remission at week 12 defined as a Simple Clinical Colitis Activity Index<3

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Improvement in UC symptoms

Description

defined as improvement in SCCAI

Time Frame

12 weeks

Title

markers of inflammation

Description

Laboratory markers of inflammation - CRP, WBC, ANC, stool calprotectin

Time Frame

12 weeks, 6 months and 12 months

Title

Improvement in UC endoscopic score

Description

Mayo-score

Time Frame

12 weeks, 6 months and 12 months

Title

change in gut microbiome

Description

Diversity and variability of gut microbiome

Time Frame

12 weeks, 6 and 12 months.

Title

use of treatments for UC

Description

such as glucocorticoids, immunosuppressive therapy (eg, azathioprine), or tumor necrosis factor antagonists.

Time Frame

6+12 months

Title

Extra-intestinal disease manifestations

Description

Extra-intestinal disease manifestations

Time Frame

6 and 12 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

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

Ilan Youngster, MD

Phone

972-50-6301191

yongsteri@asaf.health.gov.il

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

Nirit Keren, PhD

niritk@asaf.health.gov.il

Facility Information:

Facility Name

Assaf-HarofehMC

City

Zerifin

ZIP/Postal Code

70300

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ilan Youngster, Dr.

Phone

972-50-6301191

youngsteri@asaf.health.gov.il

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

25938992

Citation

Drekonja D, Reich J, Gezahegn S, Greer N, Shaukat A, MacDonald R, Rutks I, Wilt TJ. Fecal Microbiota Transplantation for Clostridium difficile Infection: A Systematic Review. Ann Intern Med. 2015 May 5;162(9):630-8. doi: 10.7326/M14-2693.

Results Reference

background

PubMed Identifier

27126044

Citation

Li SS, Zhu A, Benes V, Costea PI, Hercog R, Hildebrand F, Huerta-Cepas J, Nieuwdorp M, Salojarvi J, Voigt AY, Zeller G, Sunagawa S, de Vos WM, Bork P. Durable coexistence of donor and recipient strains after fecal microbiota transplantation. Science. 2016 Apr 29;352(6285):586-9. doi: 10.1126/science.aad8852.

Results Reference

background

PubMed Identifier

25954111

Citation

Rossen NG, MacDonald JK, de Vries EM, D'Haens GR, de Vos WM, Zoetendal EG, Ponsioen CY. Fecal microbiota transplantation as novel therapy in gastroenterology: A systematic review. World J Gastroenterol. 2015 May 7;21(17):5359-71. doi: 10.3748/wjg.v21.i17.5359.

Results Reference

background

PubMed Identifier

27329806

Citation

Khoruts A, Sadowsky MJ. Understanding the mechanisms of faecal microbiota transplantation. Nat Rev Gastroenterol Hepatol. 2016 Sep;13(9):508-16. doi: 10.1038/nrgastro.2016.98. Epub 2016 Jun 22.

Results Reference

background

PubMed Identifier

26042318

Citation

Drekonja D, Reich J, Gezahegn S, Greer N, Shaukat A, MacDonald R, Rutks I, Wilt T. Fecal Microbiota Transplantation for Clostridium Difficile Infection: A Systematic Review of the Evidence [Internet]. Washington (DC): Department of Veterans Affairs (US); 2014 Jul. Available from http://www.ncbi.nlm.nih.gov/books/NBK299000/

Results Reference

background

PubMed Identifier

27109966

Citation

Scaldaferri F, Pecere S, Petito V, Zambrano D, Fiore L, Lopetuso LR, Schiavoni E, Bruno G, Gerardi V, Laterza L, Pizzoferrato M, Ianiro G, Stojanovic J, Poscia A, Papa A, Paroni Sterbini F, Sanguinetti M, Masucci L, Cammarota G, Gasbarrini A. Efficacy and Mechanisms of Action of Fecal Microbiota Transplantation in Ulcerative Colitis: Pitfalls and Promises From a First Meta-Analysis. Transplant Proc. 2016 Mar;48(2):402-7. doi: 10.1016/j.transproceed.2015.12.040. Erratum In: Transplant Proc. 2018 Jan - Feb;50(1):305.

Results Reference

background

PubMed Identifier

25857665

Citation

Moayyedi P, Surette MG, Kim PT, Libertucci J, Wolfe M, Onischi C, Armstrong D, Marshall JK, Kassam Z, Reinisch W, Lee CH. Fecal Microbiota Transplantation Induces Remission in Patients With Active Ulcerative Colitis in a Randomized Controlled Trial. Gastroenterology. 2015 Jul;149(1):102-109.e6. doi: 10.1053/j.gastro.2015.04.001. Epub 2015 Apr 7.

Results Reference

background

PubMed Identifier

25836986

Citation

Rossen NG, Fuentes S, van der Spek MJ, Tijssen JG, Hartman JH, Duflou A, Lowenberg M, van den Brink GR, Mathus-Vliegen EM, de Vos WM, Zoetendal EG, D'Haens GR, Ponsioen CY. Findings From a Randomized Controlled Trial of Fecal Transplantation for Patients With Ulcerative Colitis. Gastroenterology. 2015 Jul;149(1):110-118.e4. doi: 10.1053/j.gastro.2015.03.045. Epub 2015 Mar 30.

Results Reference

background

PubMed Identifier

25322359

Citation

Youngster I, Russell GH, Pindar C, Ziv-Baran T, Sauk J, Hohmann EL. Oral, capsulized, frozen fecal microbiota transplantation for relapsing Clostridium difficile infection. JAMA. 2014 Nov 5;312(17):1772-8. doi: 10.1001/jama.2014.13875. Erratum In: JAMA. 2015 Feb 17;313(7):729.

Results Reference

background

PubMed Identifier

24890442

Citation

Kelly CR, Ihunnah C, Fischer M, Khoruts A, Surawicz C, Afzali A, Aroniadis O, Barto A, Borody T, Giovanelli A, Gordon S, Gluck M, Hohmann EL, Kao D, Kao JY, McQuillen DP, Mellow M, Rank KM, Rao K, Ray A, Schwartz MA, Singh N, Stollman N, Suskind DL, Vindigni SM, Youngster I, Brandt L. Fecal microbiota transplant for treatment of Clostridium difficile infection in immunocompromised patients. Am J Gastroenterol. 2014 Jul;109(7):1065-71. doi: 10.1038/ajg.2014.133. Epub 2014 Jun 3.

Results Reference

background

Available IPD and Supporting Information:

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

https://www.ncbi.nlm.nih.gov/pubmed/25938992

Learn more about this trial

Capsulized Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis Patients

We'll reach out to this number within 24 hrs