Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Fecal Microbiota Transplantation in Ulcerative Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03273465
Recruitment Status : Recruiting
First Posted : September 6, 2017
Last Update Posted : September 6, 2017
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 adult patients with mild-moderate UC.

The primary objective is to assess the safety and feasibility of multiple, oral, fecal microbiota transplantation,in newly diagnosed adult 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 Phase 2

Layout table for study information
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: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Fecal Microbiota Transplantation in Newly Diagnosed Patients With Ulcerative Colitis - a Double Blind, Placebo-Controlled Trial
Actual Study Start Date : March 27, 2017
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


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: Fecal transplantation
Fecal transplantation administered orally via frozen 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. Improvement in UC endoscopic score [ Time Frame: 12 weeks, 6 months and 12 months ]
    Mayo-score

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

  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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 informed consent document, including the willingness to accept risk of unrelated donor stool.
  • Ability to swallow oral medications.

Exclusion Criteria:

  • Severe, uncontrolled ulcerative colitis.
  • 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): NCT03273465


Contacts
Layout table for location contacts
Contact: Ilan Youngster, Dr. 972-50-6301191 yongsteri@asaf.health.gov.il

Locations
Layout table for location information
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:

Layout table for additonal information
Responsible Party: Assaf Harofeh MC, Dr., Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT03273465     History of Changes
Other Study ID Numbers: 0268-16-ASF
First Posted: September 6, 2017    Key Record Dates
Last Update Posted: September 6, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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
Colitis
fecal
FMT
microbiota
transplantation
Additional relevant MeSH terms:
Layout table for MeSH terms
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases