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

NCT04925440 | Completed DMC

• 1 other identifier: AFCRO-133
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Mood; Depressive Symptoms

Outcome Measures

Primary Outcomes (1)

• Changes in depressive symptoms assessed by the Beck Depression Inventory (BDI-II)

  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 Outcomes (7)

• Change in depression severity category assessed by the Patient Health Questionnaire-9 (PHQ-9)

  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.

  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

  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)

  Change from baseline compared to placebo, assessed over 8 weeks of supplement intake

• Change in quality of life assessed by the Short Form-36

  Change from baseline compared to placebo, assessed over 8 weeks of supplement intake

Study Arms (2)

Probiotic

EXPERIMENTAL

Probiotic capsules. Participants will consume 2 capsules once a day for 8 weeks.

Dietary Supplement: Bifidobacterium longum 1714® strain

Placebo

PLACEBO COMPARATOR

Placebo capsules. Participants will consume 2 capsules once a day for 8 weeks

Dietary Supplement: Placebo

Interventions

Bifidobacterium longum 1714® strain DIETARY_SUPPLEMENT

Probiotic capsules containing 5 x 10\^9 CFUs, corn-starch and magnesium stearate.

Probiotic

Placebo DIETARY_SUPPLEMENT

Capsules containing corn-starch and magnesium stearate only.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be able to give written informed consent.
• Male or female adults aged between ≥18 to ≤70 years.
• Participants with a BMI between ≥18.5 and ≤29.9 kg/m2.
• Meet the DSM-5 criteria for major depressive disorder (MDD) at screening (V0) and at baseline (V1).
• 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).
• 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:

• Participants who are at risk of suicide.
• Recent use of dietary supplements, probiotics, or other fermented foods that contain live bacteria within last 4 weeks.
• 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 physical illness (including IBS, does not include people with controlled hypertension or type II diabetes).
• 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).
• Significant psychiatric diagnosis (e.g., bipolar) other than depression.
• 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).
• Participants with a current history of drug (including illicit drug) and /or alcohol abuse at the time of enrolment.
• 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.
• Participants who are suffering from post-natal depression.
• Participants currently of childbearing potential, but not using an effective method of contraception, as outlined below:
• 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).
• Has a male sexual partner who is surgically sterilised prior to the Screening Visit and is the only male sexual partner for that participant.
• Sexual partner(s) is/are exclusively female.

Sponsors & Collaborators

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

Study Sites (1)

Atlantia Food Clinical Trials

Cork, T23 R50R, Ireland

Location

MeSH Terms

Conditions

Consciousness Disorders; Depression

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Ted Dinan

  Atlantia Food Clinical Trials

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• 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: June 4, 2021
• First Posted: June 14, 2021
• Study Start: September 13, 2021
• Primary Completion: August 4, 2022
• Study Completion: August 19, 2022
• Last Updated: November 10, 2022

Record last verified: 2022-11

Locations

IE (1)