None listed
Conditions
Brief summary
This study is for people who have recently been diagnosed with mild to moderate ulcerative colitis. In addition to their usual treatment, participants will take part in a 12-week program combining dietary support with faecal microbiota transplant (FMT) therapy. The aim is to find out whether this combination (diet plus FMT) can help improve the disease or even bring about remission. As part of the program, participants will have 2–3 sessions with a specialist dietitian, who will provide meal plans and recipes. The FMT will be delivered first through a colonoscopy, followed by a series of enemas over the 12 weeks. The main goal of the study is to assess how effective this approach is in the short term and whether there are benefits that last longer.
Interventions
Combined microbiome therapy: FMT + 4-SURE diet
The 4-SURE Diet intervention
Between Week –4 and Week 0, all enrolled participants will attend a 30-minute, one-to-one dietary education session conducted by an accredited IBD specialist dietitian (AD). The purpose of this session is to provide standardised, evidence-based education regarding the role of diet in inflammatory bowel disease, including correction of common misconceptions and clarification of non-evidence-based beliefs. Following this
Combined microbiome therapy: FMT + 4-SURE diet The 4-SURE Diet intervention Between Week –4 and Week 0, all enrolled participants will attend a 30-minute, one-to-one dietary education session conducted by an accredited IBD specialist dietitian (AD). The purpose of this session is to provide standardised, evidence-based education regarding the role of diet in inflammatory bowel disease, including correction of common misconceptions and clarification of non-evidence-based beliefs. Following this education component, the dietitian will prescribe an individualised IBD-specific dietary regimen, tailored to the participant’s clinical presentation and nutritional requirements. The prescribed dietary advice study will follow the UC-specific sulphide-reducing diet (4-SURE diet). This diet will be nutritionally replete, and participants will be advised to consume sufficient macronutrient and micronutrients to meet Australian recommended daily intakes. A comprehensive 7-day meal plan and diet manual will be provided with accompanying recipes. Follow-up consultations with the dietitian will occur at week 6 and week 12 in line with routine care for use of therapeutic diets. Tolerability, adequacy and adherence to the diet will be monitored using a 4-SURE diet questionnaire and tolerability scale. FMT Intervention MET-FMT participants will receive endoscopic (via colonoscopy) administration of open label FMT (4 syringe pack -200ml) into the caecum at week 0, followed by FMT enemas at week 2 and 6 (1 syringe 50ml). In total patients will receive 6 syringes of FMT throughout the study period. The FMT protocol will follow standards of practice and administration protocols that have been utilised both in real world, for recurrent Clostridioides difficile infection, and trial settings. We will record the stool donor and batch number for each FMT administration on our study database to ensure ease of re-identification of each specific donor. Each study participant will only receive FMT samples sourced from a single donor.
Sponsors
Central Adelaide Local Health Network
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 75 Years
Healthy volunteers
No
Inclusion criteria
• New formal diagnosis of UC within the last 6 months • Between 18 and 75 years of age (inclusive) • Mild-moderate UC disease activity as defined by a PRO2 score of 2-4 (taken as a 3-day average) • Faecal calprotectin equal to or more than 150ug/g • Biologic naive (not previously exposed to advanced therapies for the treatment of UC) • If participants are on corticosteroids, the dose must be equal to or less than 20mg (6mg for Budesonide) and participants are to commence a standard taper at week 0 (taper can be modified at the discretion of the treating gastroenterologist).
Exclusion criteria
• Recent endoscopic evidence (within the past 4 weeks) of quiescent UC disease activity as defined by a Total Mayo Score of equal to or less than 2 and/or a Mayo endoscopic sub-score of 0. • Evidence of severely active UC as defined by a Total Mayo Score of more than 10 and/or evidence of systemic toxicity (tachycardia, fever, C-reactive protein more than 40, Haemoglobin 2 segments out of 4 (right colon, transverse colon, sigmoid and left colon, and rectum), ileorectal anastomosis, proctocolectomy or ileoanal pouch surgery. • Those receiving corticosteroid therapy (more than 20mg oral corticosteroids or any dose IV corticosteroids) • Active infection and/or those requiring current antibiotic therapy • Unable to provide informed consent • Formal diagnosis of coeliac disease • Anaphylaxis or severe allergy to any food/ food products. • Unwilling to commit to following to a UC-IBD specific diet for 12-weeks • Participants enrolled in any other clinical trial • History of alcohol or drug abuse that in the opinion of the investigator may interfere with the participant’s ability to comply with the study procedures.
Outcome results
None listed