None listed
Conditions
Brief summary
This single-centre single arm prospective pilot clinical study aims to demonstrate the safety of donor FMT in patients with UP resistant to 5-ASA therapy. Participants who meet study inclusion criteria and provide informed consent will receive an induction course of 6 single donor FMT enemas over 8 weeks in addition to their standard therapy. All participants will receive a 1-week course of oral vancomycin pre-conditioning prior to FMT induction. Flexible sigmoidoscopy, 3-day diet diary, stool and blood panels will be performed prior to and upon completion of FMT enema induction course. This study will primarily assess the safety of FMT enemas in patients with UP. Our study will also assess the impact of FMT induction therapy on UP disease activity utilising clinical, endoscopic, histological and patient reported outcome measures. Changes in colonic microbial composition, diversity and function post FMT therapy will be analysed.
Interventions
- Participants who meet study inclusion criteria and provide informed consent will receive an induction course of 6 single donor FMT enemas over 8 weeks in addition to their standard therapy. FMT syringes will be administered through enemas by either trials team or self-administration at weeks 0, 1, 2, 3, 5 and 7. All FMT enemas will be administered at The Queen Elizabeth Hospital, South Australia. Each 50ml single donor FMT enema will consist of 25% stool, 65% saline and 10% glycerol. Adherenc
- Participants who meet study inclusion criteria and provide informed consent will receive an induction course of 6 single donor FMT enemas over 8 weeks in addition to their standard therapy. FMT syringes will be administered through enemas by either trials team or self-administration at weeks 0, 1, 2, 3, 5 and 7. All FMT enemas will be administered at The Queen Elizabeth Hospital, South Australia. Each 50ml single donor FMT enema will consist of 25% stool, 65% saline and 10% glycerol. Adherence will be observed through investigator administered enemas and recording of FMT administration. - All participants will receive a 1-week course of oral vancomycin pre-conditioning prior to FMT induction. Each participant will receive 125mg four times daily vancomycin for 7 days. This will commence 9 days prior to first dose of FMT administration to allow 48 hour washout period prior to FMT commencement. Strategies used to monitor adherence include dispensation records and direct recording. - All participants will receive dietary advice prior to commencement of FMT enemas. This will be administered through a dietary information sheet developed by our trial dietician. This dietary information is derived from Healthy Eating for Adults brochures published by Australian Dietary Guidelines. This dietary information sheets recommends intake of resistant starches, wholegrain products, lean meats and is not specific to ulcerative colitis. Adherence to prescribed diet will be through recording of 72 hour diet diaries. Advice is based upon consensus guidelines.
Sponsors
Central Adelaide Local Health Network (CALHN)
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
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: o No therapy for 4 weeks prior to study commencement, or o Stable doses of topical and/or oral 5-ASA for at least 4 weeks prior to study commencement, or o Stable doses of corticosteroids at doses of <20mg prednisolone for 4 weeks prior to study commencement, or o Stable doses of immunomodulator (azathioprine, mercaptopurine) for 6 weeks prior to study commencement, or o Stable 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
Outcome results
None listed