Fecal Microbiota Transplantation for Ulcerative Colitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fecal microbiota transplantation, Infusion of Saline, 5-Aminosalicylic acid(5-ASA) and/or Prednisone.
- Who it may be relevant to
- Registry conditions: Ulcerative Colitis, Fecal Microbiota Transplantation. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy and Safety of Fecal Microbiota Transplantation for Ulcerative Colitis
Overview
Fecal microbiota transplantation (FMT) is a strategy that infuses a fecal suspension containing a healthy donor's microbiota into a patient's gut to restore his/her intestinal microbiome. Fecal microbiota transplantation has been used for several disease，but the efficacy of ulcerative colitis(UC) by fecal microbiota transplantation needs to be further explored.The investigators propose to determine the efficiency and safety of FMT in patients with ulcerative colitis(UC).
Detailed description
The present clinical trial aims to re-establish a gut functionality state of intestinal flora through FMT as a therapy for ulcerative colitis(UC). We established a standard microbiota isolation from donated fresh stool in lab. Then the microbiota is transplanted to the intestine. Patients from Guangzhou First People's Hospital in this study will be assigned to receive FMT at least two times according to associated guidelines and follow-up for at least three months.
Interventions
- Procedure Fecal microbiota transplantation
200 mL of prepared fecal microbiota suspension from healthy donors' fresh feces was injected into the intestine - Procedure Infusion of Saline
Infusion of Saline - Drug 5-Aminosalicylic acid(5-ASA) and/or Prednisone
Mesalazine and/or Prednisone
Primary outcome measures
- Clinical remission in patient as assessed using Mayo score [Time frame: 12 weeks]
- Clinical improvement in patient as assessed using Mayo score [Time frame: 12 weeks]
Secondary outcome measures (1)
- Intestinal microbiota changing [Time frame: 12 weeks]
Eligibility criteria
Inclusion criteria
- Active, moderate to severe severity (Mayo score more than 6)
- Safety using history of 5-ASA
- Able to undergo endoscopy examination
Exclusion criteria
- Antibiotic using in 7 days
- High risk of toxic megacolon
- Colon cancer or neoplasia in pathophysiology
- Other severe diseases (eg: cardiovascular, respiratory, gastroenteral and kidney diseases)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Guangzhou First People's Hospital — Guangzhou
Publications
- 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
Identifiers
NCT: NCT03804931 · K-2017-103-01