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

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 1 to 2
    • Study completion date: Dec 2024 to Dec 2026
    v4
  2. Primary completion date changed from estimate of Feb 2023 to Jun 28, 2024
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Apr 2023 to Dec 2024
    • Site details revised
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 2022 to Mar 3, 2022
    • Site details revised
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05239845
Lead Sponsor Northumbria University
Collaborators: Reckitt Benckiser Group PLC
Conditions
(from sponsor)		 Sleep
Enrollment 68 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov