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Subjective Sleep QualityPhase 2NCT04167475

Effect of B. Longum 1714™ on Sleep Quality

A Phase 2 study testing Probiotic capsule in people with Subjective Sleep Quality and Objective Sleep Quality, run by PrecisionBiotics Group Ltd. at 1 site in Ireland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
What is being tested?
Probiotic capsule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
89 participants
Where
1 siteIreland
Study dates
6 Jan 2020to 23 Jun 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)
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  • 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;
  • Known allergy to any of the components of the test product
  • History of illicit drug use
  • Participation in a clinical study with an investigational product within 60 days before screening, or plans to participate in another study during the study period
  • Participant has a history of non-compliance

Trial locations and contacts

1 site in 1 country.

Ireland1 site

  • Atlantia Food Clinical Trials Ltd.

    Cork

Other trials in Ireland

About this study

Official title: 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

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.

Read the 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).

Being tested
Probiotic capsule, Placebo capsule
Keywords
Bifidobacterium longum 1714™, probiotic, sleep quality, PSQI, actigraphy, sleep latency, sleep efficiency
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Probiotic capsuleDietary 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.

  • Placebo capsuleDietary supplement

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

Study groups in NCT04167475
Study groupRoleWhat they receive
Probiotic capsuleExperimentalThe participants consume one probiotic capsule a day for 8 weeks
Receives: Dietary Supplement: Probiotic capsule
Placebo capsulePlacebo comparatorThe participants consume one placebo capsule a day for 8 weeks
Receives: Dietary Supplement: Placebo capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (7)

  1. Change in objective sleep quality, specifically sleep latency

    Assessed by actigraph

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

  2. Change in objective sleep quality, specifically sleep efficiency

    Assessed by actigraph

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

  3. Change in objective sleep quality, specifically wake episodes

    Assessed by actigraph

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

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

    Assessed by actigraph

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

  5. Change in subjectively reported sleep quality, sleep latency, and sleep efficiency

    Assessed by Pittsburgh Sleep Quality Index (PSQI) subscales. Each component has a minimum score of 0, maximum score of 3. Higher scores mean worse outcome.

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

  6. Change in daily sleep diaries

    Assess waking refreshed, night time waking and sleep quality

    Measured: Change from baseline, assessed daily during 8 weeks of supplement intake

  7. Change in daytime sleepiness, assessed by Epworth Sleepiness Scale

    Minimum score is 0, maximum score is 24. Higher scores indicate higher daytime sleepiness.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2019
  2. Study start6 Jan 2020
  3. Primary completion3 Apr 2020
  4. Study completion23 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
89 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04167475
Sponsor's protocol ID
AFCRO-108
Status last verified
Jun 2020
First submitted
15 Nov 2019
Last updated
30 Jun 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38355674

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Probiotic capsule in people with Subjective Sleep Quality and Objective Sleep Quality, run by PrecisionBiotics Group Ltd. at 1 site in Ireland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in subjective sleep quality, assessed by Pittsburgh Sleep Quality Index global score (time frame: Change from baseline, assessed at 4 and 8 weeks of supplement intake). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04167475, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2020.

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