Fecal microbiota transplantation in chronic active ulcerative colitis: influence of the donor microbiota.

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00010910
• Date of registration: 04/08/2016
• Prospective Registration: No
• Primary sponsor: Klinische Abteilung für GastroenterologieKlinik für Innere MedizinMedizinische Universität Graz
• Public title: Fecal microbiota transplantation in chronic active ulcerative colitis: influence of the donor microbiota.
• Scientific title: Fecal microbiota transplantation in chronic active ulcerative colitis: influence of the donor microbiota.
• Date of first enrolment: 16/06/2016
• Target sample size: 30
• Recruitment status: Recruiting
• URL: http://drks.de/search/en/trial/DRKS00010910
• Study type: interventional
• Study design: Allocation: N/A: single arm study; Masking: Open (masking not used); Control: uncontrolled; Assignment: single; Study design purpose: treatment
• Phase: N/A

Countries of recruitment

Austria

Contacts

• Name: Patrizia Kump
• Affiliation: Klinische Abteilung für Gastroenterologie, Medizinische Universität Graz

• Name: Patrizia Kump
• Affiliation: Klinische Abteilung für Gastroenterologie und Hepatologie Medizinische Universität Graz

Key inclusion & exclusion criteria

Inclusion criteria: Established diagnosis of UC
Active disease (total Mayo score > 4 and endoscopic subscore > 1)
Failure or intolerance of previous immunosuppressive therapy (AZA, 6-MP, MTX), or biologic therapy (anti-TNF therapy or anti-integrin therapy)
In case of concomitant medication stable dose during the whole course of trial and 8 weeks before start of the trial.
In case of concomitant steroid therapy stable dose of steroid therapy for at least 14 days, tapering of steroids of 2,5mg every second week is allowed.
Signed informed consent

Exclusion criteria: Pregnancy, coexisting infections with clostridium difficile, salmonella, shigella, campylobacter, yersinia, EHEC, severe coagulation disorders and anticoagulation treatment (except antiplatelet monotherapy, or low dose heparin), intravenous steroids, antibiotic or probiotic use during and 14 days prior to study entry, bile salt sequestrants during and 14 days prior to study entry, contraindication to lower endoscopy, untreated IBD associated dysplasia, any previous colectomy or Jpouch, decompensated liver cirrhosis known active malignancy (except for basal skin cancer, squamous cell skin cancer), received investigational new drug within 1 month before study entry, fever > 38.3 ºC


Age minimum: 14 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative colitis

K51

Intervention(s)

Group 1: patients (n=30) with chronic active ulcerative colitis refractory to standard therapy, total Mayo score >4, endoscopic subscore >1. After antibiotic pretreatment, 5 colonoscopically applied FMTs will be performed as an add on therapy in 14-days intervals. Donors (n=10) will be randomized in a 1:3 ratio in order to investigate the influence of the donor microbiota on clinical benefit of FMT after 90 days.

Primary Outcome(s)

To determine a donor profile microbiome signature associated with clinical response at day 90 to FMT in chronic active UC patients.

Secondary Outcome(s)

to evaluate clinical response (reduction of at least 3 points in the total Mayo socre) and clinical remission (total Mayo score < or equal 2) at day 28 and day 90 after FMT, to characterize donor microbiome features

Source(s) of Monetary Support

Klinische Abteilung für GastroenterologieKlinik für Innere MedizinMedizinische Universität Graz

Ethics review

Status: Approved
Approval date: 07/06/2011
Contact:

Ethikkommission Med.Universität Graz [Ethikkomission der Universität Graz Auenbruggerplatz 2, 3. OG A-8036 Graz Österreich]

Results

• URL: http://drks.de/search/en/trial/DRKS00010910#studyResults