Depression, AnxietyNCT05564767
Effect of Two Probiotic Formulations on Mental Health and Mood Biomarkers in Adults With Depressive Symptoms
A study testing B. adolescentis Bif-038 and Lacticaseibacillus rhamnosus, LGG® and Bifidobacterium, BB-12® in people with Depression, Anxiety, run by Chr Hansen at 1 site in Australia.
Trial summary
This is a 3-arm, parallel-group, randomized, double-blind, placebo-controlled pilot trial. Sixty adults presenting with depressive symptoms will be randomly allocated to one of 3 groups comprising (1) Bifidobacterium adolescentis or (2) Lactocaseibacillus rhamnosus LGG and Bifidobacterium BB-12 or (3) a placebo for 12… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- B. adolescentis Bif-038 and Lacticaseibacillus rhamnosus, LGG® and Bifidobacterium, BB-12®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteAustralia
- Study dates
- 17 Oct 2022to 20 Mar 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Generally healthy adults (male and female) 18 to 65 years
- Currently experiencing depressive symptoms as indicated by a score of between 20 and 40 on the BDI-II at both the screening and baseline visit
- Body mass index (BMI) between 18.5 and 30.0 kg/m2
- Non-smoker
- No plan to change dietary or exercise habits during the study period
- No recent history (within 3 months) or plan to commence new treatments over the study period
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- Willing and able to take probiotic/placebo regimen for 12 weeks
- Understand, willing and able to comply with all study procedures
- Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.
Who cannot join
- Suffering from recently diagnosed or unmanaged medical conditions including but not limited to: diabetes, hyper/hypotension, cardiovascular disease, a gastrointestinal disease requiring regular use of medications, gallbladder disease, autoimmune disease, endocrine disease, acute or chronic pain condition, or cancer/malignancy
- Diagnosis of psychiatric or neurological conditions including but not limited to: psychiatric disorders other than mild-to-moderate depression and/or anxiety disorder, or neurological disease (e.g., Parkinson's, Alzheimer's disease, intracranial hemorrhage, head or brain injury)
- Regular medication intake, including but not limited to anticholinergics, anti-epileptics, acetylcholinesterase inhibitors, benzodiazepines, antipsychotics, opioids, or corticosteroids.
- Within 2 months before screening, the use of pharmaceutical medications, including but not limited to immunosuppressant drugs, antibiotics, and steroids
- Change in medication (dose or type) in the last 3 months or an expectation to change during the study duration. Permitted medications include, but are not limited to, pharmaceutical antidepressants such as selective serotonin reuptake inhibitors (SSRIs), and serotonin and norepinephrine reuptake inhibitors (SNRIs), cholesterol-lowering medications, antihypertensives, proton pump inhibitors, and thyroid medications,
- Use of probiotics or mood support supplement up to 4 weeks before study commencement
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- Current or 12-month history of illicit drug abuse
- Alcohol intake greater than 14 standard drinks per week
- Any significant surgeries over the last year
- Women who are pregnant, breastfeeding or intend to fall pregnant
Trial locations and contacts
1 site in 1 country.
Australia1 site
Clinical Research Australia
Duncraig, Western Australia, 6023
About this study
Official title: Effect of Two Probiotic Formulations on Mental Health and Mood Biomarkers in Adults With Depressive Symptoms: A Pilot Randomized Placebo-controlled Trial
This is a 3-arm, parallel-group, randomized, double-blind, placebo-controlled pilot trial. Sixty adults presenting with depressive symptoms will be randomly allocated to one of 3 groups comprising (1) Bifidobacterium adolescentis or (2) Lactocaseibacillus rhamnosus LGG and Bifidobacterium BB-12 or (3) a placebo for 12 weeks.
At baseline (Visit 2), midpoint (Visit 3) and end-of-study (Visit 4) visits, participants meeting eligibility criteria will complete the BDI-II, BAI, DASS-21 and PROMIS Sleep questionnaires and blood samples will be collected for biomarker assessments. Fecal samples will be collected prior to the baseline and end-of-study visits for microbial profiling.
Read the detailed description
This is a 3-arm, parallel-group, randomized, double-blind, placebo-controlled pilot trial. Sixty adults presenting with depressive symptoms will be randomly allocated to one of 3 groups comprising (1) Bifidobacterium adolescentis or (2) Lactocaseibacillus rhamnosus LGG and Bifidobacterium BB-12 or (3) a placebo for 12 weeks.
At screening (Visit 1), the study design will be explained to participants, following which signed GDPR and study informed consent will be obtained. Participants will be assessed for eligibility, medical history and concomitant therapies.
At baseline (Visit 2), midpoint (Visit 3) and end-of-study (Visit 4) visits, participants meeting eligibility criteria will complete the BDI-II, BAI, DASS-21 and PROMIS Sleep questionnaires and blood samples will be collected for biomarker assessments. Fecal samples will be collected prior to the baseline and end-of-study visits for microbial profiling.
- Conditions
- Depression, Anxiety
- Being tested
- B. adolescentis Bif-038, Lacticaseibacillus rhamnosus, LGG® and Bifidobacterium, BB-12®, Placebo
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B. adolescentis Bif-038Dietary supplement
- adolescentis Bif-038 (probiotic capsule) delivered orally once daily at a minimum of 5 billion CFU/day
Lacticaseibacillus rhamnosus, LGG® and Bifidobacterium, BB-12®Dietary supplement
Lacticaseibacillus rhamnosus, LGG® and Bifidobacterium, BB-12® (probiotic capsule) delivered orally once daily at a minimum of 1 billion CFU/day
PlaceboDietary supplement
Placebo capsule delivered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| B. adolescentis Bif-038 | Experimental | Probiotic capsule (single strain) Receives: Dietary Supplement: B. adolescentis Bif-038 |
| Lacticaseibacillus rhamnosus, LGG® and Bifidobacterium, BB-12® | Experimental | Probiotic capsule (combination strain) Receives: Dietary Supplement: Lacticaseibacillus rhamnosus, LGG® and Bifidobacterium, BB-12® |
| Placebo | Placebo comparator | Placebo capsule Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory-II (BDI-II) score
Change in BDI-II score after 12 weeks
Measured: 12 weeks
Secondary outcomes (6)
Beck Anxiety Inventory (BAI) score
Change in BAI score
Measured: 12 weeks
Depression, Anxiety, Stress Scale (DASS-21) total score
Change in DASS-21 total score
Measured: 12 weeks
DASS-21 Stress score
Change in DASS-21 Stress score
Measured: 12 weeks
DASS-21 Depression score
Change in DASS-21 Depression score
Measured: 12 weeks
DASS-21 Anxiety score
Change in DASS-21 Anxiety score
Measured: 12 weeks
Brain-derived neurotrophic factor blood concentration
Change in brain-derived neurotrophic factor blood concentration
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start17 Oct 2022
- Primary completion20 Mar 2023
- Study completion20 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, AnxietyStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chr Hansen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adrian Lopresti, PhD, Principal investigator, Clinical Research Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05564767
- Sponsor's protocol ID
- HND-MH-051
- Status last verified
- Aug 2023
- First submitted
- 29 Sep 2022
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Two Probiotic Formulations on Mental Health and Mood Biomarkers in Adults With Depressive Symptoms: A Pilot Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT05564767
- Acronym / sponsor ID
- HND-MH-051
- Conditions
- Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Chr HansenIndustry (pharma, biotech, devices)
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 20 Mar 2023 (actual)
- Study completion
- 20 Mar 2023 (actual)
- First posted
- 4 Oct 2022 (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.
This is a 3-arm, parallel-group, randomized, double-blind, placebo-controlled pilot trial. Sixty adults presenting with depressive symptoms will be randomly allocated to one of 3 groups comprising (1) Bifidobacterium adolescentis or (2) Lactocaseibacillus rhamnosus LGG and Bifidobacterium BB-12 or (3) a placebo for 12 weeks.
At baseline (Visit 2), midpoint (Visit 3) and end-of-study (Visit 4) visits, participants meeting eligibility criteria will complete the BDI-II, BAI, DASS-21 and PROMIS Sleep questionnaires and blood samples will be collected for biomarker assessments. Fecal samples will be collected prior to the baseline and end-of-study visits for microbial profiling.
Detailed description
This is a 3-arm, parallel-group, randomized, double-blind, placebo-controlled pilot trial. Sixty adults presenting with depressive symptoms will be randomly allocated to one of 3 groups comprising (1) Bifidobacterium adolescentis or (2) Lactocaseibacillus rhamnosus LGG and Bifidobacterium BB-12 or (3) a placebo for 12 weeks.
At screening (Visit 1), the study design will be explained to participants, following which signed GDPR and study informed consent will be obtained. Participants will be assessed for eligibility, medical history and concomitant therapies.
At baseline (Visit 2), midpoint (Visit 3) and end-of-study (Visit 4) visits, participants meeting eligibility criteria will complete the BDI-II, BAI, DASS-21 and PROMIS Sleep questionnaires and blood samples will be collected for biomarker assessments. Fecal samples will be collected prior to the baseline and end-of-study visits for microbial profiling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| B. adolescentis Bif-038 | Experimental | Dietary Supplement: B. adolescentis Bif-038Probiotic capsule (single strain) |
| Lacticaseibacillus rhamnosus, LGG® and Bifidobacterium, BB-12® | Experimental | Dietary Supplement: Lacticaseibacillus rhamnosus, LGG® and Bifidobacterium, BB-12®Probiotic capsule (combination strain) |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo capsule |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Generally healthy adults (male and female) 18 to 65 years
- Currently experiencing depressive symptoms as indicated by a score of between 20 and 40 on the BDI-II at both the screening and baseline visit
- Body mass index (BMI) between 18.5 and 30.0 kg/m2
- Non-smoker
- No plan to change dietary or exercise habits during the study period
Key exclusion criteria (10 listed)
- Suffering from recently diagnosed or unmanaged medical conditions including but not limited to: diabetes, hyper/hypotension, cardiovascular disease, a gastrointestinal disease requiring regular use of medications, gallbladder disease, autoimmune disease, endocrine disease, acute or chronic pain condition, or cancer/malignancy
- Diagnosis of psychiatric or neurological conditions including but not limited to: psychiatric disorders other than mild-to-moderate depression and/or anxiety disorder, or neurological disease (e.g., Parkinson's, Alzheimer's disease, intracranial hemorrhage, head or brain injury)
- Regular medication intake, including but not limited to anticholinergics, anti-epileptics, acetylcholinesterase inhibitors, benzodiazepines, antipsychotics, opioids, or corticosteroids.
- Within 2 months before screening, the use of pharmaceutical medications, including but not limited to immunosuppressant drugs, antibiotics, and steroids
- Change in medication (dose or type) in the last 3 months or an expectation to change during the study duration. Permitted medications include, but are not limited to, pharmaceutical antidepressants such as selective serotonin reuptake inhibitors (SSRIs), and serotonin and norepinephrine reuptake inhibitors (SNRIs), cholesterol-lowering medications, antihypertensives, proton pump inhibitors, and thyroid medications,
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 |
|---|---|---|
| B. adolescentis Bif-038B. adolescentis Bif-038 (probiotic capsule) delivered orally once daily at a minimum of 5 billion CFU/day | Dietary supplement | B. adolescentis Bif-038 |
| Lacticaseibacillus rhamnosus, LGG® and Bifidobacterium, BB-12®Lacticaseibacillus rhamnosus, LGG® and Bifidobacterium, BB-12® (probiotic capsule) delivered orally once daily at a minimum of 1 billion CFU/day | Dietary supplement | Lacticaseibacillus rhamnosus, LGG® and Bifidobacterium, BB-12® |
| PlaceboPlacebo capsule delivered orally once daily | Dietary supplement | Placebo |
Primary outcome
Beck Depression Inventory-II (BDI-II) score
Time frame: 12 weeks
Change in BDI-II score after 12 weeks
6 secondary outcomes
Beck Anxiety Inventory (BAI) score
Time frame: 12 weeks
Depression, Anxiety, Stress Scale (DASS-21) total score
Time frame: 12 weeks
DASS-21 Stress score
Time frame: 12 weeks
DASS-21 Depression score
Time frame: 12 weeks
DASS-21 Anxiety score
Time frame: 12 weeks
Brain-derived neurotrophic factor blood concentration
Time frame: 12 weeks
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 21 Aug 2023.
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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.
Adrian Lopresti, PhD principal investigator
Clinical Research Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing B. adolescentis Bif-038 and Lacticaseibacillus rhamnosus, LGG® and Bifidobacterium, BB-12® in people with Depression, Anxiety, run by Chr Hansen at 1 site in Australia.
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 9 inclusion and 10 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 21 Aug 2023. 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 Australia. 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?
Beck Depression Inventory-II (BDI-II) score (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2023.