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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00010910

Enrollment

Registered

2016-08-04

Start date

2016-06-16

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K51

Interventions

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 F

Eligibility

Sex/Gender

All

Age

14 Years to 80 Years

Inclusion 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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Countries

Austria

Contacts

Public ContactPatrizia Kump

Klinische Abteilung für Gastroenterologie und Hepatologie Medizinische Universität Graz

patrizia.kump@medunigraz.at+43 316 385 80270

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026