CompletedPhase 2

Effect of B. Longum 1714™ on Sleep Quality

Ireland89 participantsStarted 2020-01-06

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexALL

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Inclusion criteria

✓. Provide written informed consent
✓. Age: 18 to 45 years of age
✓. BMI \< 29.9 kg/m2
✓. Be willing to refrain from taking any dietary supplements or other fermented foods that contain live bacteria during the study
✓. Be willing to refrain from taking any medications or preparations to improve sleep (herbal, dietary supplements, homeopathic preparations, etc.) during the study
✓. If using products that contain nicotine or caffeine, agrees to continue current usage levels throughout the length of the study
✓. Agrees not to undertake air travel exceeding two time zones during the period of the study
✓. PSQI score of 5 and above

Exclusion criteria

✕. Less than 18 or older than 45 years of age at the time of consent
✕. Use of dietary supplements or other fermented foods that contain live bacteria
✕. Participant who has been on antibiotics during the past 3 months
✕. Participant with a malignant disease or any concomitant end-state organ disease and/or laboratory abnormalities considered by Investigators to be risky or that could interfere with data collection
✕. Participant who has a significant acute or chronic coexisting illness \[cardiovascular, history of co-existing gastrointestinal, and/or gynaecological, and/or urologic pathology (e.g. colon cancer, colitis, Crohn's, celiac, IBS, endometriosis, prostate cancer) or lactose intolerance
✕. Participant with inflammatory disorders (e.g. chronic fatigue syndrome, psoriasis, rheumatoid arthritis or any other inflammatory arthropathies)
✕. Psychiatric diagnosis other than anxiety or depression
✕. Participant who is severely immunocompromised (HIV positive, transplant patient, on antirejection medications, on a steroid for \>30 days, or chemotherapy or radiotherapy within the last year)

What they're measuring

Change in subjective sleep quality, assessed by Pittsburgh Sleep Quality Index global score

Timeframe: Change from baseline, assessed at 4 and 8 weeks of supplement intake

Trial details

NCT IDNCT04167475

SponsorPrecisionBiotics Group Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-04-03

View on ClinicalTrials.gov More Subjective Sleep Quality trials