NCT03153046: Prepsy

The Effects of Prebiotics on Cognitive Functioning and Weight Gain in Psychosis

Completed NA Last updated 18 April 2019

What this trial tests

NA trial testing prebiotics in Schizophrenia in 39 participants. Completed in 30 December 2018.

Timeline

8 May 2017

Primary endpoint
30 September 2018

30 December 2018

Quick facts

Lead sponsor	University of Oxford
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	other
Enrollment	39
Start date	8 May 2017
Primary completion	30 September 2018
Estimated completion	30 December 2018
Sites	1 location across United Kingdom

Drugs / interventions tested

• prebiotics
• Maltodextrin (MALTODEXTRIN) — full drug profile →

Conditions studied

• Schizophrenia — all drugs for Schizophrenia →

Sponsor

University of Oxford

Who can join

Adults 18 to 60, any sex, with Schizophrenia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The investigators propose a maltodextrin-controlled cross over experimental medicine study that aims to examine 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 24 weeks; GOS for 12 weeks and maltodextrin for 12 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 3 specified time points.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pharmacological and Mechanistic Interventions for Cognitive Impairment Associated With Schizophrenia: A Review of Registered Clinical Trials.
   Peyrovian B, Palaniyappan L, Kolivakis TT, Margolese HC. · · 2026 · PMID 40908273 · DOI 10.1111/acps.70034
2. Abstracts for the Sixth Biennial SIRS Conference
   · 2018
3. F87. SERUM PROLACTIN LEVELS AND COGNITIVE OUTCOME IN FIRST EPISODE PSYCHOSIS: A PROSPECTIVE 1-YEAR FOLLOW-UP STUDY
   Bonet M, Montalvo I, Estrada F, Ahuir Perez M, et al · · 2018
4. F90. SOCIAL INFERENCE AND BELIEFS DIFFER IN INDIVIDUALS WITH SUBCLINICAL PERSECUTORY DELUSIONAL TENDENCIES
   Wellstein K, Diaconescu A, Bischof M, Ranganadan A, et al · · 2018
5. F89. COGNITIVE IMPAIRMENT WORSENING ACROSS AFFECTIVE TO PSYCHOSIS SPECTRUM: A COHORT STUDY OF UNIPOLAR/BIPOLAR DEPRESSION AND BIPOLAR SCHIZOAFFECTIVE DISORDERS
   Roy M, Strippoli M, Vandeleur C, Gilbert E, et al · · 2018
6. F88. MANIPULATION OF THE GUT MICROBIOTA WITH A PREBIOTIC IN SCHIZOPHRENIA: A DOUBLE-BLINDED RANDOMIZED PLACEBO-CONTROLLED CROSS-OVER STUDY
   Kao A, Burnet P, Lennox B. · · 2018