The Effects of Bifidobacterium Longum 1714® in a Population With Low Mood

November 9, 2022 updated by: PrecisionBiotics Group Ltd.

A Double-blind, Placebo-controlled, Randomised Study to Assess the Effects of Bifidobacterium Longum 1714® in a Population With Low Mood

A randomised, double-blind, placebo-controlled clinical trial to evaluate the effect of 8 weeks of supplementation with Bifidobacterium longum 1714® strain on Beck's Depression Inventory-II Score in adults who experience low mood.

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 Bifidobacterium longum 1714® strain in people with low mood. The 8-week intervention study will be conducted in 168 adults, aged ≥18 to ≤70 years, who experience low mood, and experience mild or moderate depression, according to the Beck's Depression Inventory II (Total score 14-28). The study will consist of 4 visits over a 10 week period commencing with a screening visit. The second visit will be the baseline (start of intervention - either active or placebo), followed by third (mid-intervention), fourth (end of treatment). Questionnaires will be administered from the first to the fifth visit and safety and research bloods will be collected at each visit throughout the trial.

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.
168

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.
  • Not Applicable

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, T23 R50R
        • Atlantia Food Clinical Trials

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

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Participants must be able to give written informed consent.
  2. Male or female adults aged between ≥18 to ≤70 years.
  3. Participants with a BMI between ≥18.5 and ≤29.9 kg/m2.
  4. Meet the DSM-5 criteria for major depressive disorder (MDD) at screening (V0) and at baseline (V1).
  5. BDI-II (Beck's Depression Inventory II) total score of 14-28 (mild [14-19] or moderate [20-28] depression) at screening (V0) and at baseline (V1).
  6. Be willing to maintain stable dietary habits and physical activity levels throughout the study period.
  7. 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. Participants who are at risk of suicide.
  2. Recent use of dietary supplements, probiotics, or other fermented foods that contain live bacteria within last 4 weeks.
  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 physical illness (including IBS, does not include people with controlled hypertension or type II diabetes).
  6. Participant who is severely immunocompromised (HIV positive, transplant patient, on anti-rejection medications, on a steroid for >30 days, or chemotherapy or radiotherapy within the last year).
  7. Significant psychiatric diagnosis (e.g., bipolar) other than depression.
  8. 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, St. John's Wort).
  9. Participants with a current history of drug (including illicit drug) and /or alcohol abuse at the time of enrolment.
  10. Participants who are pregnant (determined by urine pregnancy test for all individuals of childbearing potential at screening, regardless of contraceptive use or relationship status), breastfeeding, or wish to become pregnant during the study.
  11. Participants who are suffering from post-natal depression.

  12. Participants currently of childbearing potential, but not using an effective method of contraception, as outlined below:

    1. Complete abstinence from intercourse two weeks prior to administration of Investigational Product, throughout the clinical trial, until the completion of follow-up procedures or for two weeks following discontinuation of the Investigational Product in cases where participant discontinues the study prematurely. (Participants utilising this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding 2 weeks when they present to the clinic for the Final Visit).
    2. Has a male sexual partner who is surgically sterilised prior to the Screening Visit and is the only male sexual partner for that participant.
    3. Sexual partner(s) is/are exclusively female.
    4. Use of acceptable method of contraception, such as a spermicide, mechanical barrier (e.g., male condom, female diaphragm) or contraceptive pill. The participant must be using this method for at least 2 weeks prior to use of the Investigational Product and at least 1 week following the end of the study.
    5. Use of any non-hormonal intrauterine device (IUD) or contraceptive implant with published data showing that the highest expected failure rate is less than 1 % per year. The participant must have the device inserted at least 2 weeks prior to the first Screening Visit, throughout the study, and 2 weeks following the end of the study.
  13. Known allergy to any of the components of the test product.
  14. 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.
  15. Participant has a history of non-compliance or in the opinion of physician deemed unsuitable to participate in the study.

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
Probiotic capsules. Participants will consume 2 capsules once a day for 8 weeks.
Dietary supplement: Bifidobacterium longum 1714® strain
Probiotic capsules containing 5 x 10^9 CFUs, corn-starch and magnesium stearate.
Placebo Comparator: Placebo
Placebo capsules. Participants will consume 2 capsules once a day for 8 weeks
Dietary supplement: Placebo
Capsules containing corn-starch and magnesium stearate only.

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
Changes in depressive symptoms assessed by the Beck Depression Inventory (BDI-II)
Time Frame: Change from baseline compared to placebo, assessed over 8 weeks of supplement intake
Severity of depression as measured by the BDI-II (range 0-63, with higher scores reflecting worse outcome)
Change from baseline compared to placebo, assessed over 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 depression severity category assessed by the Patient Health Questionnaire-9 (PHQ-9)
Time Frame: Change from baseline compared to placebo, assessed over 8 weeks of supplement intake
Depression Severity category scores are as follows: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.
Change from baseline compared to placebo, assessed over 8 weeks of supplement intake
Change in fatigue assessed by the Visual Analogue Scale (VAS) for fatigue.
Time Frame: Change from baseline compared to placebo, assessed over 8 weeks of supplement intake
The instrument possesses 18 items which has two subscales: fatigue (items 1-5 and 11-18) and energy (items 6-10). Each item is scored from 0-100 with higher scores indicating more fatigue or more energy.
Change from baseline compared to placebo, assessed over 8 weeks of supplement intake
Change in subjective sleep quality, assessed by Pittsburgh Sleep Quality Index global score
Time Frame: Change from baseline compared to placebo, assessed over 8 weeks of supplement intake
Minimum score is 0, maximum score is 21. Higher scores indicate worse sleep quality.
Change from baseline compared to placebo, assessed over 8 weeks of supplement intake
Change in stress assessed by the by Cohen's Perceived Stress Scale (PSS)
Time Frame: Change from baseline compared to placebo, assessed over 8 weeks of supplement intake
The PSS is a 14 item questionnaire with each item scored from 0-4. The total score ranges from 0-56 with a higher score indication more stress.
Change from baseline compared to placebo, assessed over 8 weeks of supplement intake
Change in quality of life assessed by the Short Form-36
Time Frame: Change from baseline compared to placebo, assessed over 8 weeks of supplement intake
The SF-36 is a self-administered questionnaire comprising 36-items measuring eight health domains: physical functioning (10 items), role limitation due to physical health problems (4 items), bodily pain (2 items), general health perceptions (5 items), vitality (4 items), social functioning (2 items), role limitations due to emotional problems (3 items), and general mental health (5 items). These outcomes will be grouped as physical component summary and mental component summary. The norm data is 0-100, the health related quality of life is increases as the scores are increased. The average score is 50.
Change from baseline compared to placebo, assessed over 8 weeks of supplement intake
Changes in depressive symptoms assessed by the Beck Depression Inventory (BDI-II)
Time Frame: Change from baseline compared to placebo, assessed at 4 weeks of supplement intake
Severity of depression as measured by the BDI-II (range 0-63, with higher scores reflecting worse outcome)
Change from baseline compared to placebo, assessed at 4 weeks of supplement intake
Changes in mood category assessed by the Beck Depression Inventory (BDI-II)
Time Frame: Change from baseline compared to placebo, assessed at 4 weeks of supplement intake
Severity of depression as measured by the BDI-II (range 0-63, with higher scores reflecting worse outcome)
Change from baseline compared to placebo, assessed at 4 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.
Atlantia Food Clinical Trials

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.
  • Principal Investigator: Ted Dinan, Atlantia Food Clinical Trials

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.
September 13, 2021

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.
August 4, 2022

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.
August 19, 2022

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).
June 4, 2021

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.
June 4, 2021

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.
June 14, 2021

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.
November 10, 2022

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.
November 9, 2022

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.
November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

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-133

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings