A human intervention study using HMOs to improve IBS symptoms.
Research type
Research Study
Full title
A double-blind, crossover intervention study using human milk oligosaccharides (HMOs) to improve Irritable Bowel Syndrome (IBS) symptoms through targeting of the gut microbiota.
IRAS ID
326109
Contact name
Patricia Sanz Morales
Contact email
Sponsor organisation
The University of Reading
Duration of Study in the UK
2 years, 4 months, 1 days
Research summary
This study will evaluate whether a human milk oligosaccharide (HMO) intervention shifts the gut microbiome of people with IBS towards a "healthier" signature, as measured by a selective increase in bifidobacteria, and whether this intervention improves IBS symptoms compared to placebo.
The crossover design signifies patients are their own control subjects, reducing possible variation due to placebo effect commonly seen in IBS therapy.
44 participants will be randomised to take either the HMO or a placebo for 28 days, then have a 28-day period with no product, then swap to the other treatment for another 28 days. There will be a 14-day follow-up period both at the beginning and the end of the trial.
During the 16-week study, participants will provide urine and stool samples at weeks 2, 6, 10 and 14. Additionally, participants will complete validated questionnaires to assess their sleep, IBS symptoms, anxiety and depression.REC name
South West - Frenchay Research Ethics Committee
REC reference
23/SW/0042
Date of REC Opinion
24 Apr 2023
REC opinion
Favourable Opinion