Clinical Trial

Evaluating the Effects of Prebiotics on Sleep, the Gut Microbiome, Cognition, Immune Function and Stress

Active, Not Recruiting
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Summary
The aim of the proposed randomised, double-blind, controlled, parallel groups trial is to assess the sleep, gut microbiome, cognitive, immune and stress effects of 56 days administration of three formulations of a prebiotic-based intervention, in comparison to a placebo control, in a cohort of healthy adults reporting poor sleep quality.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2022-02-14; most recent amendment 2026-01-14.
Status change: Recruiting → Active, Not Recruiting 2024-10-22
Status change: Not Yet Recruiting → Recruiting 2022-09-26
Trial Details
NCT Number NCT05239845
Lead Sponsor Northumbria University
Collaborators: Reckitt Benckiser Group PLC
Conditions Sleep
Enrollment 68 participants
Start Date 2022-03-03
Primary Completion 2024-06-28 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-01-16