Low MoodNCT04925440
The Effects of Bifidobacterium Longum 1714® in a Population With Low Mood
A study testing Bifidobacterium longum 1714® strain in people with Low Mood and Depressive Symptoms, run by PrecisionBiotics Group Ltd. at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Mood, Depressive Symptoms
- What is being tested?
- Bifidobacterium longum 1714® strain
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 1 siteIreland
- Study dates
- 13 Sep 2021to 19 Aug 2022
- Phase
- Interventional
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 20Show fewer
- 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.
- 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.
- 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.
- Known allergy to any of the components of the test product.
- 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 or in the opinion of physician deemed unsuitable to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Low Mood, Depressive Symptoms
- Being tested
- Bifidobacterium longum 1714® strain, Placebo
- Medical subject headings
- Consciousness Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium longum 1714® strainDietary supplement
Probiotic capsules containing 5 x 10^9 CFUs, corn-starch and magnesium stearate.
PlaceboDietary supplement
Capsules containing corn-starch and magnesium stearate only.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Probiotic capsules. Participants will consume 2 capsules once a day for 8 weeks. Receives: Dietary Supplement: Bifidobacterium longum 1714® strain |
| Placebo | Placebo comparator | Placebo capsules. Participants will consume 2 capsules once a day for 8 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Depression Severity category scores are as follows: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.
Measured: 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.
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.
Measured: 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
Minimum score is 0, maximum score is 21. Higher scores indicate worse sleep quality.
Measured: 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)
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.
Measured: Change from baseline compared to placebo, assessed over 8 weeks of supplement intake
Change in quality of life assessed by the Short Form-36
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.
Measured: 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)
Severity of depression as measured by the BDI-II (range 0-63, with higher scores reflecting worse outcome)
Measured: 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)
Severity of depression as measured by the BDI-II (range 0-63, with higher scores reflecting worse outcome)
Measured: Change from baseline compared to placebo, assessed at 4 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.
- First posted14 Jun 2021
- Study start13 Sep 2021
- Primary completion4 Aug 2022
- Study completion19 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low MoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- PrecisionBiotics Group Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials
- Responsible party
- Sponsor
- Investigators
- Ted Dinan, Principal investigator, Atlantia Food Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04925440
- Sponsor's protocol ID
- AFCRO-133
- Status last verified
- Nov 2022
- First submitted
- 4 Jun 2021
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Seamans KM, Patterson E, Holz C, Groeger D, Junnila J, Collins F, Murphy EF, Sorensen K, Dinan TG. Effects of Bifidobacterium longum 1714 on low mood and related symptoms: A randomized, double-blind, placebo-controlled trial. Exp Clin Psychopharmacol. 2026 Aug;34(4):341-351. doi: 10.1037/pha0000839. Epub 2026 Apr 30.
PubMed 42060410
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Randomised Study to Assess the Effects of Bifidobacterium Longum 1714® in a Population With Low Mood
- ClinicalTrials.gov ID
- NCT04925440
- Acronym / sponsor ID
- AFCRO-133
- Conditions
- Low Mood, Depressive Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- PrecisionBiotics Group Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- 4 Aug 2022 (actual)
- Study completion
- 19 Aug 2022 (actual)
- First posted
- 14 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: Bifidobacterium longum 1714® strainProbiotic capsules. Participants will consume 2 capsules once a day for 8 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo capsules. Participants will consume 2 capsules once a day for 8 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (20 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bifidobacterium longum 1714® strainProbiotic capsules containing 5 x 10^9 CFUs, corn-starch and magnesium stearate. | Dietary supplement | Probiotic |
| PlaceboCapsules containing corn-starch and magnesium stearate only. | Dietary supplement | Placebo |
Primary outcome
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)
7 secondary outcomes
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Derived from this study: PubMed 42060410Seamans KM, Patterson E, Holz C, Groeger D, Junnila J, Collins F, Murphy EF, Sorensen K, Dinan TG. Effects of Bifidobacterium longum 1714 on low mood and related symptoms: A randomized, double-blind, placebo-controlled trial. Exp Clin Psychopharmacol. 2026 Aug;34(4):341-351. doi: 10.1037/pha0000839. Epub 2026 Apr 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ted Dinan principal investigator
Atlantia Food Clinical Trials
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bifidobacterium longum 1714® strain in people with Low Mood and Depressive Symptoms, 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 7 inclusion and 20 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 10 Nov 2022. 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.
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?
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). 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 NCT04925440, 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 10 Nov 2022.