Effect of B. Longum 1714™ on Sleep Quality

June 29, 2020 updated by: PrecisionBiotics Group Ltd.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
89

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Cork, Ireland
        • Atlantia Food Clinical Trials Ltd.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Provide written informed consent
  2. Age: 18 to 45 years of age
  3. BMI < 29.9 kg/m2
  4. Be willing to refrain from taking any dietary supplements or other fermented foods that contain live bacteria during the study
  5. Be willing to refrain from taking any medications or preparations to improve sleep (herbal, dietary supplements, homeopathic preparations, etc.) during the study
  6. If using products that contain nicotine or caffeine, agrees to continue current usage levels throughout the length of the study
  7. Agrees not to undertake air travel exceeding two time zones during the period of the study
  8. PSQI score of 5 and above
  9. HADS-A and HADS-D score of 14 and below
  10. ISI score below 11
  11. Be willing to maintain stable dietary habits and physical activity levels throughout the study period
  12. 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

Exclusion Criteria:

  1. Less than 18 or older than 45 years of age at the time of consent
  2. Use of dietary supplements or other fermented foods that contain live bacteria
  3. Participant who has been on antibiotics during the past 3 months
  4. 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
  5. 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
  6. Participant with inflammatory disorders (e.g. chronic fatigue syndrome, psoriasis, rheumatoid arthritis or any other inflammatory arthropathies)
  7. Psychiatric diagnosis other than anxiety or depression
  8. 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)
  9. 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)
  10. Combined SF36 score of greater than +2 SD from the mean
  11. Participants with a history of drug and /or alcohol abuse at the time of enrolment
  12. Pregnant or lactating female, or pregnancy planned during study period
  13. Participants who have undertaken air travel involving transit across two or more time zones in the month previous to the study
  14. Participants who are shift workers
  15. Participants with sleep disorders diagnosed by a physician such as sleep apnoea;
  16. Known allergy to any of the components of the test product
  17. History of illicit drug use
  18. 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
  19. Participant has a history of non-compliance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Probiotic capsule
The participants consume one probiotic capsule a day for 8 weeks
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.
Placebo Comparator: Placebo capsule
The participants consume one placebo capsule a day for 8 weeks
Dietary supplement: Placebo capsule
Each placebo capsule contains corn starch and magnesium stearate. The placebo capsules will be supplied by PrecisionBiotics Ltd.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in objective sleep quality, specifically sleep latency
Time Frame: Change from baseline, assessed at 4 and 8 weeks of supplement intake
Assessed by actigraph
Change from baseline, assessed at 4 and 8 weeks of supplement intake
Change in objective sleep quality, specifically sleep efficiency
Time Frame: Change from baseline, assessed at 4 and 8 weeks of supplement intake
Assessed by actigraph
Change from baseline, assessed at 4 and 8 weeks of supplement intake
Change in objective sleep quality, specifically wake episodes
Time Frame: Change from baseline, assessed at 4 and 8 weeks of supplement intake
Assessed by actigraph
Change from baseline, assessed at 4 and 8 weeks of supplement intake
Change in objective sleep quality, specifically wake time after sleep onset (WASO)
Time Frame: Change from baseline, assessed at 4 and 8 weeks of supplement intake
Assessed by actigraph
Change from baseline, assessed at 4 and 8 weeks of supplement intake
Change in subjectively reported sleep quality, sleep latency, and sleep efficiency
Time Frame: Change from baseline, assessed at 4 and 8 weeks of supplement intake
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.
Change from baseline, assessed at 4 and 8 weeks of supplement intake
Change in daily sleep diaries
Time Frame: Change from baseline, assessed daily during 8 weeks of supplement intake
Assess waking refreshed, night time waking and sleep quality
Change from baseline, assessed daily during 8 weeks of supplement intake
Change in daytime sleepiness, assessed by Epworth Sleepiness Scale
Time Frame: Change from baseline, assessed at 4 and 8 weeks of supplement intake
Minimum score is 0, maximum score is 24. Higher scores indicate higher daytime sleepiness.
Change from baseline, assessed at 4 and 8 weeks of supplement intake

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
PrecisionBiotics Group Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Nottingham Trent University
Atlantia Food Clinical Trials Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Eileen Murphy, PhD, PrecisionBiotics Group Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 6, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 3, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 23, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 15, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 30, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AFCRO-108

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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