NCT04167475

Effect of B. Longum 1714™ on Sleep Quality

A Randomised, Double-blinded, Placebo-controlled, Parallel-group, Pilot Study to Assess the Effectiveness of the B. Longum 1714™ Strain on Subjective and Objective Sleep Quality in Healthy Men and Women

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: PrecisionBiotics Group Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to evaluate the effect of supplementation with the B. longum 1714™ strain on subjective and objective sleep quality in healthy participants.

Detailed description

This is a randomized, double-blind, placebo-controlled, parallel group study, designed to assess the effectiveness \& safety of the B. longum 1714™ strain, when consumed once daily, on sleep quality. The 8-week intervention study will be conducted in otherwise healthy participants with a Pittsburgh Sleep Quality Index (PSQI) score of greater than, or equal to 5, a HADS-A and HAD-D score less than or equal to 14 and an Insomnia Severity Index of less than 11. Participants (N=90) will be pre-screened online, then visit the study site 4 times during the course of the 8 - 10 weeks' study (2 weeks screening period, followed by 8-week intervention). The first visit will be for screening, second visit will be baseline (and start of intervention - either active or placebo), third visit will be mid-intervention, and fourth visit will be at the end of intervention. Questionnaires will be administered at visit 2, 3 and 4, and research blood and saliva will also be collected at these time points. Hair sample will be taken at visit 2 and 4 while stool sample will be collected at visit 4. Participants will wear an actigraph and fill in a sleep eDiary for the whole intervention period (from visit 2 to visit 4).

Conditions

• Subjective Sleep Quality
• Objective Sleep Quality

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic capsule	Each probiotic capsule contains 1 x 10\^9 CFU B. longum 1714™ with corn starch and magnesium stearate. The probiotic capsules will be supplied by PrecisionBiotics Ltd.
DIETARY_SUPPLEMENT	Placebo capsule	Each placebo capsule contains corn starch and magnesium stearate. The placebo capsules will be supplied by PrecisionBiotics Ltd.

Timeline

• Start date: 2020-01-06
• Primary completion: 2020-04-03
• Completion: 2020-06-23
• First posted: 2019-11-18
• Last updated: 2020-06-30

Locations

1 site across 1 country: Ireland