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Efficacy of Fecal Microbiota Transplantation for Inflammatory Bowel Disease

This study is currently recruiting participants.
See Contacts and Locations
Verified October 2015 by Hakan Demirci, Gulhane Military Medical Academy
Sponsor:
Information provided by (Responsible Party):
Hakan Demirci, Gulhane Military Medical Academy
ClinicalTrials.gov Identifier:
NCT02575040
First received: October 6, 2015
Last updated: October 12, 2015
Last verified: October 2015
  Purpose
The gut microbiota is determined to constitute a "microbial organ" which has pivotal roles in the intestinal diseases and body's metabolism. Evidence from animal and human studies strongly supports the link between intestinal bacteria flora and inflammatory bowel diseases. Lots of studies showed its efficacy in treatment of severe Clostridium difficile colitis. Corticosteroid dependence in patients with ulcerative colitis (UC) and Crohn's disease (CD) is an important clinical problem and maintenance of steroid-free remission is a key treatment goal. Early studies using fecal microbiota transplantation (FMT) for Ulcerative Colitis (UC) and Crohn's diseases have also met with success. This is an first step into investigating the potential efficacy of standardized FMT through terminal ileum for UC and CD, the investigators propose to determine the efficiency and safety of FMT in a series of 80 patients with moderate to severe UC and CD.

Condition Intervention Phase
Ulcerative Colitis Crohn Disease Constipation (Excl Faecal Impaction) Biological: Fecal microbiota transplantation Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Fecal Microbiota Transplantation for Refractory Inflammatory Bowel Disease

Resource links provided by NLM:


Further study details as provided by Hakan Demirci, Gulhane Military Medical Academy:

Primary Outcome Measures:
  • Patients with worsened disease [ Time Frame: one year ]
    Number of patients with worsened disease. Increase in Montreal score S1, S2 and S3.

  • Adverse events [ Time Frame: one year ]
    Number of adverse events


Estimated Enrollment: 60
Study Start Date: May 2015
Estimated Study Completion Date: May 2020
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Fecal microbiota transplantation
Fecal microbiota transplantation only
Biological: Fecal microbiota transplantation
Fecal microbiota transplantation to patients with ulcerative colitis and Crohn disease

Detailed Description:

Intestinal microbiota have a major role in disease pathogenesis, either in a form of a "permissive" role or as a direct pathogenic cause.

Clostridium difficile colitis; irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD) have all been connected to a disturbance in the equilibrium of intestinal microbiome. The cause of IBD in unknown but evidence is getting that immense immune reaction of intestinal immune system to microflora combined with a genetic predisposition are responsible for the chronic inflammation.

Fecal microbial treatment (FMT) is a treatment that utilizes the microbiota of a healthy intestine as a probiotic preparation. The fecal material of a healthy individual is fluidized and that inserted into the intestinal tract of a sick individual, assuming that the healthy flora will colonize and cure the intestine. Previous work had shown success in fecal transplantation as a treatment for clostridium difficile colitis. There are also reports of the efficacy of this treatment for inflammatory bowel disease but currently the numbers are small. 41 cases were reported , In some the FMT was inserted through a nasogastric tube directly to the duodenum, in some be colonoscopy and in some by an enema. A significant clinical improvement was reported in 19 of 25 patients. 13 of 17 stopped IBD treatment , 15 of 24 entered full clinical remission. In all 15 patients treated for infection the treatment was successful. No sever adverse effects were reported, Fever was developed in 8 cases and in one case there was exacerbation of colitis after treatment.

Primary aim: To investigate whether use of FMT will bring improvement of at least 2 points in partial mayo score in ulcerative colitis patients, or 75 points in CDAI of patients with Crohn's colitis. One month after FMT.

Improvement will be defined as:

For Ulcerative colitis: 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 Crohn's disease activity index (CDAI).

80 patients aged >18 years, with histological and endoscopic diagnosis of ulcerative colitis (UC) or CD who did not respond to either thiopurines or tumor necrosis factor (TNF) inhibitors.

Flare will be defined as partial mayo score higher then 3, with either C reactive protein (CRP) higher than 6 or endoscopic mayo score >1 in ulcerative colitis and CDAI higher them 220 and CRP higher than 6 in Crohn's colitis.

Stool will be donated by the patients choice either from a relative, preferably a partner to minimize possible transference of an infective agent, alternatively samples will be ordered from "open biom".

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent
  • Inflammatory bowel disease diagnosed at least 6 months ago
  • Failure of either one immunomodulator of at least 3 months duration, or TNF inhibitor full induction treatment, or corticosteroids, or intolerance to either of these drugs.
  • Currently active disease, partial Mayo score ≥4 for ulcerative colitis, or CDAI ≥200 for CD.
  • negative HIV , Human T-cell leukemia virus I/II, negative stool culture, Negative C diff toxin, negative Cytomegalovirus

Exclusion Criteria:

  • No informed consent
  • Non active inflammatory bowel disease.
  • Active infection in either the donor or the recipient,
  • Response to biological agents
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02575040

Contacts
Contact: Hakan Demirci, M.D. 00905325140028 hakandemircigata@yahoo.com

Locations
Turkey
Gulhane Military Medical Academy Recruiting
Ankara, Turkey, 06010
Contact: Hakan Demirci, M.D.    00905325140028    hakandemircigata@yahoo.com   
Sponsors and Collaborators
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Investigators
Principal Investigator: Ahmet Uygun, Prof Gulhane Military Medical Academy, Department of Gastroenterology
  More Information

Publications:
Responsible Party: Hakan Demirci, doctor, Gulhane Military Medical Academy
ClinicalTrials.gov Identifier: NCT02575040     History of Changes
Other Study ID Numbers: GMMA-Fecal Tx-1
Study First Received: October 6, 2015
Last Updated: October 12, 2015

Additional relevant MeSH terms:
Fecal Impaction
Crohn Disease
Colitis, Ulcerative
Constipation
Intestinal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colitis
Colonic Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Intestinal Obstruction

ClinicalTrials.gov processed this record on July 24, 2017