None listed
Conditions
Brief summary
On average, only 50% of IBS patients respond to the first-line treatment of low FODMAP diet. The non-responders may have gut microbiome dysbiosis that requires targeted treatment. Recent RCTs have shown improvement in IBS symptoms using faecal microbiota transplantation (FMT) from healthy donors in IBS symptom scores up to 3 months, with the proposed mechanism being the correction of gut dysbiosis, However, there is a lack of studies into the impact of FMT in combined with low FODMAP therapy to optimise the improvement of IBS symptoms. This study aims to investigate whether the novel therapy of FMT improves IBS symptoms for IBS patients without significant symptom improvement after a low FODMAP diet. Methods: IBS patients with moderate to severe symptoms will be enrolled into a dietician-led 3 week low FODMAP treatment. The patients who do not have symptomatic improvement will be randomised into receiving FMT or placebo. Studies suggest that altering microbial composition via FMT might also lead to improvements in cognitive function. Therefore, we will investigate cognitive function at baseline compared to follow-up in a subsample of 20 enrolled participants. In contrast to participants of the overarching clinical trial, sub study participants will undergo additional cognitive testing, which takes around 50 minutes per visit, and will be asked to fill out additional mood and quality of life questionnaires, which will add another 10 minutes to study visits. This result in a total study visit time of 80 minutes for substudy participants, as opposed to 20 minutes for participants of the overarching trial, who will only fill out two questionnaires on IBS-symptom severity. Cognitive function will be assessed via Cambridge Automated Neuropsychological Test Battery (CANTAB), a validated, computer-based, neuropsychological test battery that allows testing for cognitive changes in different cognitive domains, including memory, processing speed, and executive function. To assess the impact of mood and stress on IBS symptom severity, mood will be assess via the Depression, Anxiety and Stress Scale (DASS) and quality of life via IBS-QoL.
Interventions
All participants will be administered the low FODMAP diet prior to the faecal microbiota transplantation. If there is no improvement in IBS-SSS score post low FODMAP then participants will enter randomisation into FMT vs placebo.
low FODMAP diet
- will be administered by a qualified dietician
- adherence will be assessed through the use of a food diary with weekly reviews by the dietician over 3 weeks.
Faecal microbiota transplantation
- this will be administered via a single 60ml rectal ret
All participants will be administered the low FODMAP diet prior to the faecal microbiota transplantation. If there is no improvement in IBS-SSS score post low FODMAP then participants will enter randomisation into FMT vs placebo. low FODMAP diet - will be administered by a qualified dietician - adherence will be assessed through the use of a food diary with weekly reviews by the dietician over 3 weeks. Faecal microbiota transplantation - this will be administered via a single 60ml rectal retention enema in one clinic visit - one donor will be used for each participant - adherence to FMT will be 100% as it is administered by the study investigator and the subject will be monitored for 30 minutes Only participants who do not improve on the low Fodmap diet will be invited to participate in the sub study investigating additional cognitive outcomes. Participants in the substudy will be subject to the same intervention as the overarching trial, i.e. being randomised to receive a single dose of placebo or FMT. Substudy participants will only be asked to fill out additional questionnaires and cognitive tests at baseline and follow-up visits, while intervention or study duration/number of visits does not differ between substudy and overarching trial participants. 20 participants will be invited to take part in the substudy. The time needed for cognitive tests and additional questionnaires will add another 60 minutes to each study visit for participants in the substudy. This results in a total study visit time of 80 minutes at baseline and four follow-up visits for substudy-participants, as opposed to a study visit time of 20 minutes for participants of the overarching trial.
Sponsors
Vincent Ho
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged 18 years old or over 2. Diagnosed with irritable bowel syndrome as per ROME IV criteria 3. An outpatient 4. Lack of symptomatic improvement with the low FODMAP diet
Exclusion criteria
1. Presence of systemic disease 2. Pregnant, planning pregnancy or lactating. 3. Having undergone any abdominal surgery, with the exception of appendectomy, cholecystectomy, caesarean section and hysterectomy. 4. Severe psychiatric disorder, or alcohol or drug abuse. 5. Use of probiotics or treatment with antibiotics within 8 weeks prior to study entry 6. Use of IBS medication within the previous 3 months, with the exception of polyethylene glycol and loperamide. 7. Active gastroenteritis
Outcome results
None listed