Examining the role of faecal microbiota transplantation (FMT) to induce remission in resistant ulcerative proctitis (UP): A pilot study

Not Applicable

• Conditions: lcerative Colitis; Ulcerative Colitis; Oral and Gastrointestinal - Inflammatory bowel disease

• Registration Number: ACTRN12621001041842
• Lead Sponsor: Central Adelaide Local Health Network (CALHN)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-09
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

•Patients aged 18-80
•Formal diagnosis of UC for a period of greater than or equal to 3 months
•Endoscopic Assessment confirming disease activity limited to 30cm from the anal verge
•Mild-moderate UP disease activity as defined by total Clinical Mayo Score 3-10 with a Mayo endoscopic sub-score greater than 0
•Prior histological assessment consistent with UC
•Current or prior use of either oral or topical 5-ASA therapy
•Participants on stable therapy for defined periods:
oNo therapy for 4 weeks prior to study commencement, or
oStable doses of topical and/or oral 5-ASA for at least 4 weeks prior to study commencement, or
oStable doses of corticosteroids at doses of <20mg prednisolone for 4 weeks prior to study commencement, or
oStable doses of immunomodulator (azathioprine, mercaptopurine) for 6 weeks prior to study commencement, or
oStable doses of biological therapy for 8 weeks prior to study commencement

Exclusion Criteria

•<18 years or >80 years of age
•Quiescent UP activity as defined by total Clinical Mayo Score of < 3 and/or Mayo endoscopic sub-score of 0
•Severe UP as defined by total Clinical Mayo Score > 10 and/or evidence of systemic toxicity as defined by Truelove and Witts Criteria (Heart Rate > 90, fever > 37.8C, ESR >30, Hb <110)
•Participants with histological diagnosis consistent with Crohn’s Disease
•Participants with evidence of active infection of current/recent use of antibiotics within 1 month of enrolment
•Participants currently receiving corticosteroids at doses of >20mg prednisolone or any IV corticosteroids
•Participants who have undergone prior colonic surgery
•Participants who are unable to provide informed consent
•Participants who are pregnant or breast-feeding
•Participants who are currently enrolled in any other clinical trial
•Participants who have had any HIV or viral hepatitis exposure in the last 12 months
•Participants with a family history of colorectal carcinoma involving two or more first-degree relatives
•Participants who have an active malignancy
•Participants with current history of intravenous drug use
•Participants with liver cirrhosis or primary sclerosing cholangitis
•Participants with significant psychiatric or medical co-morbidities

Study & Design

• Study Type: Interventional
• Study Design: Not specified