NCT02391012

Brief Summary

Fecal microbial treatment (FMT) is a treatment that utilizes the microbiota of a healthy intestine as a probiotic preparation. The feces of a healthy individual is fluidized and than inserted into the intestinal tract of a sick individual, assuming that the healthy flora will colonize and cure the intestine. There are reports of the efficacy of this treatment for inflammatory bowel disease but currently the numbers are small. aim: To investigate whether use of FMT will bring improvement for colitis in IBD patients . Methods: The patients will undergo full colonoscopy, the stool preparation will be infused through the colonoscope during withdrawal of the instrument.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 18, 2015

Completed
14 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

June 14, 2016

Status Verified

June 1, 2016

Enrollment Period

1.2 years

First QC Date

March 5, 2015

Last Update Submit

June 13, 2016

Conditions

Inflammatory Bowel Disease

Keywords

Ulcerative colitisCrohns diseaseMicrobial transplantation

Outcome Measures

Primary Outcomes (1)

  • Improvement of disease activity index.

    : a decrease of at least 2 points in the partial mayo score, and a decrease of at least 1 point in endoscopic Mayo score. For Crohn's disease: A decrease of at least 70 points in CDAI.

    4 weeks

Secondary Outcomes (5)

  • improvement of endoscopic score

    4 weeks

  • Maintenance of remission/ improvement during follow up

    6 months

  • Patients perspective of the treatment (do patients regard the treatment as acceptable)

    6 months

  • Cost estimation of the treatment

    6 months

  • side effects (presence of fever,or rise of 50% or more in the number of bowel movements)

    6 months

Study Arms (1)

Fecal microbial l transplantation

EXPERIMENTAL

patients with active colitis who will undergo treatment by fecal microbial transplantation

Biological: Fecal microbial l transplantation

Interventions

Fecal microbial l transplantationBIOLOGICAL

infusion of preparation of fecal preparation from a healthy donor to a colitis patient

Also known as: FMT
Fecal microbial l transplantation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent
  • Inflammatory bowel disease diagnosed at least 3 months ago
  • Failure of either one immunomodulator of at least 3 months duration, or TNF inhibitor full induction treatment, or intolerance to either of these drugs.
  • Currently active disease, partial Mayo score ≥4 for ulcerative colitis, or CDAI ≥200 for CD.
  • negative HIV , HTLV I/II, negative stool culture, Negative C diff toxin, negative CMV

You may not qualify if:

  • No informed consent
  • Non active inflammatory bowel disease.
  • Active infection in either the donor or the recipient,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Meir hospital

Kfar Saba, 44281, Israel

Location

Gastroenterology institute Meir Hospital

Kfar Saba, Israel

Location

Related Publications (1)

  • Anderson JL, Edney RJ, Whelan K. Systematic review: faecal microbiota transplantation in the management of inflammatory bowel disease. Aliment Pharmacol Ther. 2012 Sep;36(6):503-16. doi: 10.1111/j.1365-2036.2012.05220.x. Epub 2012 Jul 25.

    PMID: 22827693BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel DiseasesColitis, UlcerativeCrohn Disease

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Study Officials

  • Timna Naftali, MD

    Meir Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 5, 2015

First Posted

March 18, 2015

Study Start

April 1, 2015

Primary Completion

June 1, 2016

Study Completion

July 1, 2016

Last Updated

June 14, 2016

Record last verified: 2016-06

Locations

IL(2)