Differences in gut bacteria of patients with Clostridium difficile infection and patients with ulcerative colitis before and after faecal microbiota transplantation

Single centre, proof-of-concept, exploratory, parallel, controlled study using high-throughput DNA sequencing techniques to compare differences in the gastrointestinal (GI) microflora of Clostridium difficile infection (CDI) and ulcerative colitis (UC) patients before and after faecal microbiota transplantation (FMT)

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000503628

Enrollment

Registered

2014-05-12

Start date

2014-04-24

Completion date

2015-08-17

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

Faecal microbiota transplantation (FMT) is a highly successful treatment for Clostridium difficile infection (CDI) with success rates of over 90%. Success rates of FMT treatment for ulcerative colitis (UC) are lower. The success of FMT in CDI treatment is believed to be in part due to the implantation of the full complement of bacteria from the FMT into the patient's bowel. It is unclear if this implantation occurs with FMT in UC patients. The lower success rate of FMT treatment for UC may be due to a failure of the bacteria from the FMT to implant in the bowel's of UC patients. This study will compare the composition and changes in the gut bacteria before and after FMT in patients with CDI and in patients with UC.

Interventions

Faecal microbiota transplantation (FMT). 2x 150mL FMTs will be administered on consecutive days. The first FMT will be administered via a colonosocope and the second FMT will be administered via a rectal enema.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

6 months or greater history of active moderate ulcerative colitis (Mayo score of 4-10) or diarrhoea (greater than 3 motions per day) in association with a confirmed diagnosis of Clostridium difficile infection (toxin positive). Never had FMT treatment for any reason.

Exclusion criteria

Females who are pregnant or lactating. Unwilling to practice an effective method of contraception throughout the study period. Unwilling to use a sodium picosulfate-based bowel preparation. Severe anemia, leucopenia or granulocytopenia. Detection of a gastrointestinal pathogen on stool analysis, with the exception of Clostridium difficile for the Clostridium difficile infection group only. Participants with Crohn’s disease, indeterminate colitis or isolated proctitis <5 cm. Constipation-predominant ulcerative colitis with <2 bowel motions/day. Evidence or history of toxic megacolon. Any other significant gastrointestinal conditions e.g. neoplasms, irritable bowel syndrome. Participants who have had a colectomy, bowel resection or other major gastrointestinal surgery.

Outcome results