Prebiotic Study in Psychosis
Research type
Research Study
Full title
Effects of Modulating the Immune System with Prebiotics on Cognition and Weight in Patients with Psychosis
IRAS ID
214951
Contact name
Belinda Lennox
Contact email
Sponsor organisation
University of Oxford
Duration of Study in the UK
1 years, 10 months, 1 days
Research summary
We propose a maltodextrin-controlled cross over experimental medicine study that aims to investigate the role of the immune system in cognitive processes and weight gain in 40 adult patients with psychosis, stable on antipsychotic medication for over 1 month.
There is evidence suggesting the immune system is linked to brain function and weight gain, both parameters that has been implicated in psychosis and antipsychotic use, and may underlie some schizophrenic features. The fermentation of galacto-oligosaccharides (GOS), which are short chain carbohydrates composed mostly of galactose sugar molecules, by the intestinal microbiota has been shown to modulate the immune system and reduce the inflammatory response in both animals and humans. Since the intestinal ecosystem is highly sensitive to dietary changes, the growth of beneficial gut bacteria can be enhanced using a natural food supplement similar to GOS known as prebiotics. The study will be controlled by taking maltodextrin as a control supplement. Both prebiotics and maltodextrin are short chain sugar compounds.
The study will involve asking patients to take dietary supplement for a total of 18 weeks, where they will take GOS for 12 weeks and maltodextrin for 6 weeks as a control. Participants will be randomised into groups, with half receiving maltodextrin followed by GOS, and half receiving GOS followed by maltodextrin.
Participants will be assessed on cognitive function and weight gain at 4 specified time points.REC name
South Central - Oxford B Research Ethics Committee
REC reference
16/SC/0654
Date of REC Opinion
23 Dec 2016
REC opinion
Favourable Opinion