Effect of B. Longum 1714™ on Sleep Quality

NCT04167475 | Completed Phase 2 DMC

• 1 other identifier: AFCRO-108
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Subjective Sleep Quality; Objective Sleep Quality

Keywords

Bifidobacterium longum 1714™; probiotic; sleep quality; PSQI; actigraphy; sleep latency; sleep efficiency

Outcome Measures

Primary Outcomes (1)

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

  Minimum score is 0, maximum score is 21. Higher scores indicate worse sleep quality.

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

Secondary Outcomes (7)

• Change in objective sleep quality, specifically sleep latency

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

• Change in objective sleep quality, specifically sleep efficiency

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

• Change in objective sleep quality, specifically wake episodes

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

• Change in objective sleep quality, specifically wake time after sleep onset (WASO)

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

• Change in subjectively reported sleep quality, sleep latency, and sleep efficiency

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

Study Arms (2)

Probiotic capsule

EXPERIMENTAL

The participants consume one probiotic capsule a day for 8 weeks

Dietary Supplement: Probiotic capsule

Placebo capsule

PLACEBO COMPARATOR

The participants consume one placebo capsule a day for 8 weeks

Dietary Supplement: Placebo capsule

Interventions

Probiotic capsule DIETARY_SUPPLEMENT

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.

Probiotic capsule

Placebo capsule DIETARY_SUPPLEMENT

Each placebo capsule contains corn starch and magnesium stearate. The placebo capsules will be supplied by PrecisionBiotics Ltd.

Placebo capsule

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• HADS-A and HADS-D score of 14 and below
• ISI score below 11
• Be willing to maintain stable dietary habits and physical activity levels throughout the study period
• Be able to communicate well with the Investigator, to understand and comply with the requirements of the study and be judged suitable for the study in the opinion of the Investigator

You may not qualify if:

• 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)
• Participants who are on anxiolytics, anti-depressants, antipsychotics, anticonvulsants, centrally acting corticosteroids, opioid pain relievers, hypnotics, and/or prescribed sleep medication/ herbals (e.g. valerian)
• Combined SF36 score of greater than +2 SD from the mean
• Participants with a history of drug and /or alcohol abuse at the time of enrolment
• Pregnant or lactating female, or pregnancy planned during study period
• Participants who have undertaken air travel involving transit across two or more time zones in the month previous to the study
• Participants who are shift workers
• Participants with sleep disorders diagnosed by a physician such as sleep apnoea;

Sponsors & Collaborators

• PrecisionBiotics Group Ltd.: lead
• Nottingham Trent University: collaborator
• Atlantia Food Clinical Trials: collaborator

Study Sites (1)

Atlantia Food Clinical Trials Ltd.

Cork, Ireland

Location

Related Publications (1)

• Patterson E, Tan HTT, Groeger D, Andrews M, Buckley M, Murphy EF, Groeger JA. Bifidobacterium longum 1714 improves sleep quality and aspects of well-being in healthy adults: a randomized, double-blind, placebo-controlled clinical trial. Sci Rep. 2024 Feb 14;14(1):3725. doi: 10.1038/s41598-024-53810-w.

  PMID: 38355674 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Eileen Murphy, PhD

  PrecisionBiotics Group Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: November 18, 2019
• Study Start: January 6, 2020
• Primary Completion: April 3, 2020
• Study Completion: June 23, 2020
• Last Updated: June 30, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)