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Efficacy of Fecal Microbiota Transplantation for Inflammatory Bowel Disease

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ClinicalTrials.gov Identifier: NCT02575040
Recruitment Status : Unknown
Verified October 2015 by Hakan Demirci, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi.
Recruitment status was:  Recruiting
First Posted : October 14, 2015
Last Update Posted : October 14, 2015
Sponsor:
Information provided by (Responsible Party):
Hakan Demirci, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Ulcerative Colitis Crohn Disease Constipation (Excl Faecal Impaction) Biological: Fecal microbiota transplantation Phase 3

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".

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Fecal Microbiota Transplantation for Refractory Inflammatory Bowel Disease
Study Start Date : May 2015
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Fecal microbiota transplantation
Fecal microbiota transplantation only
 Biological: Fecal microbiota transplantation
Fecal microbiota transplantation to patients with ulcerative colitis and Crohn disease


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

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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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): NCT02575040


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

Locations
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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
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Principal Investigator: Ahmet Uygun, Prof Gulhane Military Medical Academy, Department of Gastroenterology
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hakan Demirci, doctor, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
ClinicalTrials.gov Identifier: NCT02575040    
Other Study ID Numbers: GMMA-Fecal Tx-1
First Posted: October 14, 2015    Key Record Dates
Last Update Posted: October 14, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Fecal Impaction
Constipation
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Signs and Symptoms, Digestive
Intestinal Obstruction