Faecal Microbiota Transplantation in Irritable Bowel Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 28 April 2015
• Main ID: NCT02423421
• Date of registration: 10/03/2015
• Prospective Registration: No
• Primary sponsor: University College Cork
• Public title: Faecal Microbiota Transplantation in Irritable Bowel Syndrome
• Scientific title: Randomised Placebo Controlled Trial of Faecal Microbiota Transplantation in Irritable Bowel Syndrome
• Date of first enrolment: March 2015
• Target sample size: 50
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT02423421
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Ireland

Contacts

• Name: Fergus Shanahan, MD, DSc
• Affiliation: Professor and Chair Dept. of Medicine, University College Cork

• Name: Donal Sheehan, MB BAO BCH

• Name: Susan Rafferty - McArdle, PHD

Key inclusion & exclusion criteria

Inclusion Criteria:

To be considered eligible for enrolment into the study, subjects must;

- Be able to give written informed consent.

- Males and females aged >18 and <65

- Have IBS as defined by the Rome III criteria

Exclusion Criteria:

Subjects will be excluded from the study if they meet any of the below criteria;

- Are less than 18 and greater than 65 years of age.

- Have a significant acute or chronic coexisting illness (cardiovascular,
gastrointestinal, endocrine, immunological, metabolic or any condition which
contraindicates, in the investigators' judgment, entry to the study).

Individuals who, in the opinion of the investigator, are considered to be poor attendees
or unlikely for any reason to be able to comply with the trial.

- Are receiving treatment involving experimental drugs.

- If the subject has been in a recent experimental trial, these must have been
completed not less than 30 days prior to this study.

- Have a malignant disease or any concomitant end-stage organ disease Pregnancy

- Use of antibiotics within 6 weeks of screening.

- Use of systemic steroids within the last month.

- Use of an antipsychotic within prior 3 months.

- Have suffered from a major psychiatric disorder with the past two years.

- Lactose intolerance.

- Those > 55 will be excluded if they have not had a sigmoidoscopy or colonoscopy
within previous 5 years.

- Any abdominal surgery other than hernia repair or appendicectomy.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Irritable Bowel Syndrome

Intervention(s)

Other: Faecal microbiota transplantation

Primary Outcome(s)

Global Assessment of relief of IBS symptoms. [Time Frame: 8 weeks]

Secondary Outcome(s)

Primary symptoms of IBS [Time Frame: 8 weeks]

Safety as measured by occurrence of adverse events [Time Frame: 8 weeks]

Depression and Anxiety [Time Frame: 8 weeks]

Quality of life [Time Frame: 8 weeks]

Secondary ID(s)

APC053

Source(s) of Monetary Support

Please refer to primary and secondary sponsors