Efficacy of Fecal Microbiota Transplantation for Inflammatory Bowel Disease

NCT02575040 | Unknown Phase 3 DMC

• 1 other identifier: GMMA-Fecal Tx-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis; Crohn Disease; Constipation (Excl Faecal Impaction)

Outcome Measures

Primary Outcomes (2)

• Patients with worsened disease

  Number of patients with worsened disease. Increase in Montreal score S1, S2 and S3.

  one year

• Adverse events

  Number of adverse events

  one year

Study Arms (1)

Fecal microbiota transplantation

OTHER

Fecal microbiota transplantation only

Biological: Fecal microbiota transplantation

Interventions

Fecal microbiota transplantation BIOLOGICAL

Fecal microbiota transplantation to patients with ulcerative colitis and Crohn disease

Fecal microbiota transplantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi Gulhane Tip Fakultesi: lead

Study Sites (1)

Gulhane Military Medical Academy

Ankara, 06010, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• Cui B, Li P, Xu L, Zhao Y, Wang H, Peng Z, Xu H, Xiang J, He Z, Zhang T, Nie Y, Wu K, Fan D, Ji G, Zhang F. Step-up fecal microbiota transplantation strategy: a pilot study for steroid-dependent ulcerative colitis. J Transl Med. 2015 Sep 12;13:298. doi: 10.1186/s12967-015-0646-2.

  PMID: 26363929 RESULT

• Wei Y, Zhu W, Gong J, Guo D, Gu L, Li N, Li J. Fecal Microbiota Transplantation Improves the Quality of Life in Patients with Inflammatory Bowel Disease. Gastroenterol Res Pract. 2015;2015:517597. doi: 10.1155/2015/517597. Epub 2015 Jun 4.

  PMID: 26146498 RESULT

• 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.

  PMID: 25954111 RESULT

• Uygun A, Ozturk K, Demirci H, Oger C, Avci IY, Turker T, Gulsen M. Fecal microbiota transplantation is a rescue treatment modality for refractory ulcerative colitis. Medicine (Baltimore). 2017 Apr;96(16):e6479. doi: 10.1097/MD.0000000000006479.

  PMID: 28422836 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease; Constipation

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Ahmet Uygun, Prof

  Gulhane Military Medical Academy, Department of Gastroenterology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hakan Demirci, M.D.

CONTACT

00905325140028; hakandemircigata@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: October 6, 2015
• First Posted: October 14, 2015
• Study Start: May 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2020
• Last Updated: October 14, 2015

Record last verified: 2015-10

Locations

TU (1)