Healthy AgingAnexLBNCT07110896
Study Evaluating the Effect of Humiome® Post LB on Stress, Anxiety, and Cognition in Aging Adults
A study testing Humiome Post LB (Postbiotic) in people with Healthy Aging, run by dsm-firmenich Switzerland AG at 3 sites in 2 countries.
Trial summary
To assess the effect of 3 months of daily consumption of a postbiotic (inactivated lactic acid bacteria) Humiome® Post LB on stress measured by the Depression Anxiety Stress Scale-21 (DASS-21) adjusted on baseline in study participants when compared to placebo Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- What is being tested?
- Humiome Post LB (Postbiotic)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 236 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Aug 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant is male or female, 50-75 years of age, inclusive.
- Participant has a Body Mass Index (BMI) of ≥18.5 kg/m2 to 32 kg/m2.
- Participant is generally in good health, as per investigator's judgement at V1.
- Participant has subjective mild to moderate memory complaints, as per investigator's judgement.
- Participant has a total score of ≥42 and ≤60 on the DASS-21 administered at V1.
- Participant is willing to maintain regular dietary, exercise, and allowed medication/supplement habits and smoking and other nicotine habits (if a smoker or nicotine user) for the duration of the study.
- Participant understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator.
- 7. Participant understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator.
Who cannot join
- Participant has a history or presence of a psychiatric or neurologic disease including epilepsy, cerebrovascular disease, traumatic brain injury, dementia, Alzheimer's Disease, clinical depression, or other clinically significant psychiatric/neurologic condition that, in the opinion of the investigator, could interfere with the interpretation of the study results.
- MMSE score at V1 < 21.
- Chronic fatigue syndrome.
- Women: elevated stress and/or anxiety levels clearly related to the (peri) menopause complaints, as per investigator judgement
- Non-pharmacological or non-supplementation options for management of stress, anxiety or memory/cognitive complaints (e.g. yoga, "brain jogging") started within 4 weeks of screening 6. Participant has a clinically significant gastrointestinal, endocrine, cardiovascular, renal, hepatic, pulmonary, pancreatic, neurologic, or biliary disorder that, in the opinion of the investigator, could interfere with the interpretation of the study results.
- 7. Participant has a condition that would likely cause immunosuppression. 8. Participant has a history of gastrointestinal surgery (cholecystectomy and appendectomy are acceptable, considering the prevalence in the age group), as per investigator judgement. 9. Participant has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg) at screening.
Show all 16Show fewer
- 10. Participant has an issue with hearing or seeing that might interfere with the tasks/questionnaires to be completed during the visits.
- 11. Participant has used pre-, pro-, syn-, or post-biotic supplements within 90 days of screening.
- 12. Participant has a history of using psychotropic medications (including antidepressants and tranquilizers), stimulant medications, and/or narcotics within 4 weeks of screening. 13. Participants has major sleep disorder (severe insomnia) based on investigator's judgment.
- 14. Participant has used sleep aid medications, supplements, and/or products, including antihistamines, within 2 weeks of screening (washout prior to screening is allowed). Sporadic use of supplementation of melatonin, valerian, passion flower, lavender, if needed, if this has been habitually or occasionally done prior to the study, is allowed. 15. Participant has used an acid-blocking medication (e.g., proton pump inhibitor, H2 blocker) in the past 30 days prior to study. However, any ongoing use started at least 12 weeks before Visit 1 is allowed.
- 16. Participant has used selective serotonin reuptake inhibitors (SSRIs) or benzodiazepines in the past 30 days. (Note: Participants will not be excluded on the basis of a well-managed depressive disorder that does not require SSRIs.) 17. Participant has a history of cancer in the prior 5 years. 18. Participant has an allergy to any components of the IP or the standardized breakfast.
- 19. Individual has signs or symptoms of an active infection of clinical significance or has taken antibiotics within 30 days prior to any visit (washout is permitted for re-scheduling of the clinic visit).
- 20. Participant has been exposed to any non-registered drug product within 30 days of the screening visit.
- 21. Participant has a current or recent history (within 12 months of screening) or strong potential for illicit drug or excessive alcohol intake defined as >14 drinks per week (1 drink = 350 ml beer, 150 ml wine, or 40 ml hard liquor).
- 22. Women lactating, pregnant or of childbearing potential not using a reliable contraceptive method.
- 23. Participant has a condition the investigator believes would interfere with his/her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
France2 sites, 2 recruiting
- Recruiting
Biofortis
Paris, 75012
Stéphanie Cavigioli, dr, +33 (0)1 45 84 44 57, stephanie.cavigioli@biofortis.fr
Basile Frilley, +33 2 40 20 57 99, basile.frilley@biofortis.fr
- Recruiting
Biofortis
Saint-Herblain, 44800
Stéphanie Cavigioli, dr, +33 (0)1 45 84 44 57, stephanie.cavigioli@biofortis.fr
Basile Frilley, +33 2 40 20 57 99, basile.frilley@biofortis.fr
Germany1 site, 1 recruiting
- Recruiting
analyze & realize GmbH
Berlin, 10369
Liana Vismane, Dr., +493040008122, lvismane@a-r.com
Natalie Doberstein, +493040008156, ndoberstein@a-r.com
About this study
Official title: A Randomized, Placebo-controlled, Double-blind Clinical Study to Evaluate the Effect of Humiome® Post LB on Stress, Anxiety, and Cognition in Aging Adults
To assess the effect of 3 months of daily consumption of a postbiotic (inactivated lactic acid bacteria) Humiome® Post LB on stress measured by the Depression Anxiety Stress Scale-21 (DASS-21) adjusted on baseline in study participants when compared to placebo
Read the detailed description
A double-blinded, randomised and placebo-controlled study will be conducted to assess the effect of 3 months of daily consumption of a postbiotic (inactivated lactic acid bacteria), Humiome® Post LB, on stress measured by the Depression Anxiety Stress Scale-21 (DASS-21) adjusted for baseline in study participants when compared to placebo.
The study will be in healthy subjects who are getting older (ageing population) and will measure factors such as stress, sleep, anxiety as well as gut microbiome. The intervention period will be 90 days, and study will include 236 subjects in two arms (active and placebo),
- Conditions
- Healthy Aging
- Being tested
- Humiome Post LB (Postbiotic), Placebo
- Keywords
- Healthy aging, Microbiome, Stress, Sleep, Anxiety, gut-brain
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Humiome Post LB (Postbiotic)Dietary supplement
Also called Lactobacillus LB
Heat-inactivated lactobacilli with fermented medium (a postbiotic) in 340mg powder format
PlaceboDietary supplement
Also called microcrystalline cellulose
Microcrystalline cellulose, 340mg powder format
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Humiome Post LB (Postbiotic) : 340mg in 2 identical capsules per day orally Receives: Dietary Supplement: Humiome Post LB (Postbiotic) |
| Placebo | Placebo comparator | Microcrystalline in 2 identical capsules per day orally Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on stress
To assess the effect of 3 months of daily consumption of Humiome® Post LB on stress measured by the Depression Anxiety Stress Scale-21 (DASS-21) adjusted on baseline in study participants when compared to placebo
Measured: Timeframe - Day 0 (V2), and Day 90 (V4)
Secondary outcomes (14)
Effect on stress (adjusted to baseline)
To assess the effect of 3 months of daily consumption of Humiome® Post LB on stress measured by the Depression Anxiety Stress Scale-21 (DASS-21) adjusted on baseline in study participants when compared to placebo. Lowest Value: 0, Highest Value: 42. A higher score means a worse outcome
Measured: Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4)
Effect on stress (within the group)
To assess the effect of 3 months of daily consumption of Humiome® Post LB on change in DASS-21 subscores of stress, depression, anxiety in study participants when compared to placebo (between group comparison) and baseline (withingroup comparison). Lowest Value: 0, Highest Value: 42. A higher score means a worse outcome
Measured: (Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4)
Effect on stress (within the group, compared to baseline)
To assess the effect of 3 months of daily consumption of Humiome® Post LB and Placebo on stress measured by the DASS-21 in study participants when compared to baseline. Lowest Value: 0, Highest Value: 42. A higher score means a worse outcome.
Measured: (Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4)
Effect on indicators of Anxiety
To assess the effect of 3 months of daily consumption of Humiome® Post LB on indicators of anxiety when compared to placebo and baseline . The GAD-7 total score (range 0-21, expressed in a.u.) will be used to assess indicators of anxiety. Lowest Value: 0 Highest Value: 21. A higher score means a worse outcome
Measured: Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4)
Effect on indicators of perceived stress
To assess the effect of 3 months of daily consumption of Humiome® Post LB on indicators of perceived stress when compared to placebo and baseline. The PSS-10 total score (range 0-40; expressed in a.u.) will be used to assess indicators of perceived stress. Lowest Value: 0, Highest Value: 40. A higher score means a worse outcome,
Measured: Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4)
Effect on Indicators of cognition and memory
To assess the effect of 3 months of daily consumption of Humiome® Post LB on indicators of Indicators of cognition and memory when compared to placebo and baseline. Cogstate International Digit Symbol Substitution Test (symbols) will be used to test domains processing speed test, assesses focused attention and aspects of executive functioning; the outcome is the total number of correct responses
Measured: Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4)
Effect on indicators of Chronic inflammation (hs-CRP) in blood
To assess the effect of 3 months of daily consumption of Humiome® Post LB on indicators of Chronic inflammation in blood when compared to placebo and baseline. For this hs-CRP levels in blood will be measured.
Measured: Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4)
Effect on indicators of Chronic inflammation (homocysteine) in blood
To assess the effect of 3 months of daily consumption of Humiome® Post LB on indicators of Indicators of Chronic inflammation in blood when compared to placebo and baseline. For this homocysteine levels in blood, will be measured.
Measured: Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4)
Effect on indicators of Chronic inflammation (BDNF) in blood
To assess the effect of 3 months of daily consumption of Humiome® Post LB on indicators of Indicators of Chronic inflammation in blood when compared to placebo and baseline. For this BDNF (brain-derived neurotrophic factor protein) in blood will be measured.
Measured: Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4)
Effect on indicators of Chronic inflammation (IL-11) in blood
To assess the effect of 3 months of daily consumption of Humiome® Post LB on indicators of Indicators of Chronic inflammation in blood when compared to placebo and baseline. For this IL-11 levels in blood will be measured.
Measured: Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4)
Effect on indicators of Chronic inflammation (IL-6) in blood
To assess the effect of 3 months of daily consumption of Humiome® Post LB on indicators of Indicators of Chronic inflammation in blood when compared to placebo and baseline. For this, IL-6 levels in blood will be measured.
Measured: Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4)
Effect on indicators of Chronic inflammation (IL-10) in blood
To assess the effect of 3 months of daily consumption of Humiome® Post LB on indicators of Indicators of Chronic inflammation in blood when compared to placebo and baseline. For this IL-10 levels in blood will be measured.
Measured: Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4)
Effect on indicators of Chronic inflammation (TNF-α) in blood
To assess the effect of 3 months of daily consumption of Humiome® Post LB on indicators of Indicators of Chronic inflammation in blood when compared to placebo and baseline. For this TNF-α levels in blood will be measured.
Measured: Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4)
Effect on indicators of Chronic inflammation in feces
To assess the effect of 3 months of daily consumption of Humiome® Post LB on indicators of Indicators of Chronic inflammation in feces when compared to placebo and baseline. For this Calprotectin levels in feces will be measured
Measured: Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start1 Aug 2025
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AgingStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment A randomized, placebo-controlled, double-blind
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- dsm-firmenich Switzerland AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Analyze & Realize
- Responsible party
- Sponsor
- Investigators
- Mehdi Sadaghian, PhD, Study director, dsm-firmenich Switzerland AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07110896
- Sponsor's protocol ID
- 2024-09-06-ANEX
- Acronym
- AnexLB
- Status last verified
- Mar 2026
- First submitted
- 19 Jun 2025
- Last updated
- 6 Nov 2026
- 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 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Double-blind Clinical Study to Evaluate the Effect of Humiome® Post LB on Stress, Anxiety, and Cognition in Aging Adults
- ClinicalTrials.gov ID
- NCT07110896
- Acronym / sponsor ID
- AnexLB / 2024-09-06-ANEX
- Conditions
- Healthy Aging
- Keywords
- Healthy aging, Microbiome, Stress, Sleep, Anxiety, gut-brain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- dsm-firmenich Switzerland AGIndustry (pharma, biotech, devices)
- Collaborators
- Analyze & Realize
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 8 Aug 2025 (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.
To assess the effect of 3 months of daily consumption of a postbiotic (inactivated lactic acid bacteria) Humiome® Post LB on stress measured by the Depression Anxiety Stress Scale-21 (DASS-21) adjusted on baseline in study participants when compared to placebo
Detailed description
A double-blinded, randomised and placebo-controlled study will be conducted to assess the effect of 3 months of daily consumption of a postbiotic (inactivated lactic acid bacteria), Humiome® Post LB, on stress measured by the Depression Anxiety Stress Scale-21 (DASS-21) adjusted for baseline in study participants when compared to placebo.
The study will be in healthy subjects who are getting older (ageing population) and will measure factors such as stress, sleep, anxiety as well as gut microbiome. The intervention period will be 90 days, and study will include 236 subjects in two arms (active and placebo),
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment A randomized, placebo-controlled, double-blind
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Dietary Supplement: Humiome Post LB (Postbiotic)Humiome Post LB (Postbiotic) : 340mg in 2 identical capsules per day orally |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMicrocrystalline in 2 identical capsules per day orally |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participant is male or female, 50-75 years of age, inclusive.
- Participant has a Body Mass Index (BMI) of ≥18.5 kg/m2 to 32 kg/m2.
- Participant is generally in good health, as per investigator's judgement at V1.
- Participant has subjective mild to moderate memory complaints, as per investigator's judgement.
- Participant has a total score of ≥42 and ≤60 on the DASS-21 administered at V1.
Key exclusion criteria (16 listed)
- Participant has a history or presence of a psychiatric or neurologic disease including epilepsy, cerebrovascular disease, traumatic brain injury, dementia, Alzheimer's Disease, clinical depression, or other clinically significant psychiatric/neurologic condition that, in the opinion of the investigator, could interfere with the interpretation of the study results.
- MMSE score at V1 < 21.
- Chronic fatigue syndrome.
- Women: elevated stress and/or anxiety levels clearly related to the (peri) menopause complaints, as per investigator judgement
- Non-pharmacological or non-supplementation options for management of stress, anxiety or memory/cognitive complaints (e.g. yoga, "brain jogging") started within 4 weeks of screening 6. Participant has a clinically significant gastrointestinal, endocrine, cardiovascular, renal, hepatic, pulmonary, pancreatic, neurologic, or biliary disorder that, in the opinion of the investigator, could interfere with the interpretation of the study results.
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 |
|---|---|---|
| Humiome Post LB (Postbiotic)Also: Lactobacillus LBHeat-inactivated lactobacilli with fermented medium (a postbiotic) in 340mg powder format | Dietary supplement | Active |
| PlaceboAlso: microcrystalline celluloseMicrocrystalline cellulose, 340mg powder format | Dietary supplement | Placebo |
Primary outcome
Effect on stress
Time frame: Timeframe - Day 0 (V2), and Day 90 (V4)
To assess the effect of 3 months of daily consumption of Humiome® Post LB on stress measured by the Depression Anxiety Stress Scale-21 (DASS-21) adjusted on baseline in study participants when compared to placebo
14 secondary outcomes
Effect on stress (adjusted to baseline)
Time frame: Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4)
Effect on stress (within the group)
Time frame: (Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4)
Effect on stress (within the group, compared to baseline)
Time frame: (Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4)
Effect on indicators of Anxiety
Time frame: Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4)
Effect on indicators of perceived stress
Time frame: Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4)
Effect on Indicators of cognition and memory
Time frame: Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4)
Effect on indicators of Chronic inflammation (hs-CRP) in blood
Time frame: Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4)
Effect on indicators of Chronic inflammation (homocysteine) in blood
Time frame: Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4)
Effect on indicators of Chronic inflammation (BDNF) in blood
Time frame: Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4)
Effect on indicators of Chronic inflammation (IL-11) in blood
Time frame: Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4)
Effect on indicators of Chronic inflammation (IL-6) in blood
Time frame: Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4)
Effect on indicators of Chronic inflammation (IL-10) in blood
Time frame: Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4)
Effect on indicators of Chronic inflammation (TNF-α) in blood
Time frame: Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4)
Effect on indicators of Chronic inflammation in feces
Time frame: Timeframe - Day 0 (V2), Day 45 (V3) and Day 90 (V4)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
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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.
Mehdi Sadaghian, PhD study director
dsm-firmenich Switzerland AG
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Humiome Post LB (Postbiotic) in people with Healthy Aging, run by dsm-firmenich Switzerland AG at 3 sites in 2 countries.
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 8 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liana Vismane, DR (+493040008122, lvismane@a-r.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect on stress (time frame: Timeframe - Day 0 (V2), and Day 90 (V4)). 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 6 Nov 2026.