StressPostWelLBNCT07471659
Effect of Daily Humiome® Post LB Intake on Wellbeing in Older Individuals With Moderate Stress Levels
A study testing Humiome Post LB and Microcrystalline Cellulose in people with Stress, run by dsm-firmenich Switzerland AG at 1 site in France.
Trial summary
The placebo-controlled, double blind parallel intervention trial "PostWelLB" aims to test whether 3 months of daily supplementation with the postbiotic product "Humiome® Post LB" (HPLB; 340 mg / day) can reduce self-reported stress (PSS10 questionnaire)- in an older (50 - 75 years; all genders) population in France. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Humiome Post LB and Microcrystalline Cellulose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2026to Aug 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
- Men and women aged between 50 and 75 years old (limits included),
- Body mass index (BMI) ≥ 18.5 and < 30 kg/m²
- Presenting a level of psychological stress characterized by a PSS-10 score ≥ 14 and ≤ 26,
- For women: not at risk of pregnancy (as per definitions of Appendix 13) Participants currently of childbearing potential, using an effective method of contraception.
- Menopausal without hormone replacement therapy (estrogenic replacement therapy stopped since more than 3 months can be included)
- Good general and mental health according to the opinion of the investigator: No relevant abnormalities from medical history nor from the medical consultation
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- Agreeing to maintain lifestyle habits during the study (same dietary and physical activity habits)
- Able and willing to participate to the trial by complying with the protocol procedures as evidenced by a dated and signed ICF
- Affiliated with a social security scheme,
- With access to a health-care provider, who can be contacted by the CRO, and who reside in areas with available emergency health services,
- Agreeing to be registered in the national database of subjects participating in clinical research,
- Having a smartphone or personal computer compatible with the eConsult and ePRO applications.
Who cannot join
- Suffering from a metabolic disorder such as treated or untreated diabetes,
- Suffering from thyroid dysfunction, high blood pressure or other metabolic disorders treated for less than 6 months and/or non-stabilized,
- Suffering from a severe chronic disease: cancer, HIV, renal failure, hepatic or biliary disorders ongoing (except for cholecystectomy since more than two years and asymptomatic), chronic inflammatory digestive disease, arthritis or other chronic respiratory trouble (except for mild asthma under treatment),
- Suffering from GI disorders found to be inconsistent with the conduct of the study by the investigator (e.g. celiac disease, Chron's disease, etc.),
- With a known food allergy or intolerance or hypersensitivity to any of the trial products' ingredients,
- Women who are pregnant or lactating or intend on becoming pregnant within the following six months,
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- Having a history or presence of a psychiatric or neurologic disease including epilepsy, cerebrovascular disturbance, traumatic brain injury, dementia, Alzheimer's Disease, clinical depression, or other clinically significant psychiatric/neurologic condition that could interfere with the interpretation of the study results in the opinion of the investigator,
- Having recently experienced or currently experiencing a significant stress as per investigator's judgment (e.g. grieving, divorce, moving, etc.),
- Having a condition and/or receiving a treatment that may cause immunosuppression (e.g.: under immunomodulating treatment for HIV infection, allograft, auto-immune disease or cancer, etc.)
- Under treatment or dietary supplement which could significantly affect parameter(s) followed during the trial according to the investigator or stopped less than one month prior to V1,
- Under treatment with one or more of the following treatments stopped less than one month prior to V1:
- psychotropic medications (including antidepressants and tranquilizers), stimulant medications, and/or narcotics having an effect on stress, sleep aid medications, supplements, and/or products, including antihistamines, acid-blocking medication (e.g., proton pump inhibitor, H2 blocker),
- Under treatment with an effect on the microbiome such as antibiotics stopped less than one month prior to V1,
- Having a lifestyle deemed incompatible with the trial according to the Investigator as described below:
- Practicing a high-level of physical activity (defined as more than 10 hours of intense physical activity a week, walking excluded),
- Regularly consuming more than 2 standard drinks of alcohol daily or 14 weekly or not agreeing to keep alcohol consumption habits unchanged throughout the study,
- With a significant change in dietary or physical activity habits in the 3 months prior to randomisation (no hyper or hypocaloric diet, no high-protein diet, no prolonged fasting for more than one week, no planned change in the level of sports activity in the next 3 months),
- With a personal history of anorexia nervosa, bulimia, or significant eating disorders according to the Investigator,
- Taking part in another clinical trial or being in the exclusion period of a previous clinical trial,
- Having received, during the last 12 months, indemnities for clinical trial higher or equal to 6000 Euros,
- Under legal protection (guardianship, wardship) or deprived of rights following an administrative or judicial decision,
- Presenting a psychological or linguistic incapability to sign the ICF, Impossible to contact in case of emergency.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Biofortis
Saint-Herblain, 44800
Eleonora Rossi, PhD, +33 240205799, eleonora.rossi@biofortis.fr
Sahara Graf, +33 240205799, sahara.graf@biofortis.fr
About this study
Official title: A Randomised, Placebo-controlled, Double-blind Clinical Trial to Evaluate the Efficacy of Three Months Daily Ingestion of Humiome® Post LB on Wellbeing in 50 - 75 Year-old Adults in France
The placebo-controlled, double blind parallel intervention trial "PostWelLB" aims to test whether 3 months of daily supplementation with the postbiotic product "Humiome® Post LB" (HPLB; 340 mg / day) can reduce self-reported stress (PSS10 questionnaire)- in an older (50 - 75 years; all genders) population in France.
Read the detailed description
The clinical study "PostWelLB" aims to test whether 3 months of daily supplementation with the postbiotic product "Humiome® Post LB" (HPLB) can reduce stress in an older population compared with placebo.
The investigational product (IP) HPLB is a postbiotic according to the International Scientific Association of Probiotics and Prebiotics (ISAPP), who defined postbiotics as "preparations of inanimate micro-organisms or components thereof that provide a health benefit on the host". In essence, HPLB is a fermentation product containing heat inactivated bacterial bodies of Limosilactobacillus fermentum (CNCM I-2998) and Lactobacillus delbrueckii (CNCM I-4831) and metabolite-rich spent fermentation medium (mainly lactic acid). The product also contains lactose, which is used as drying support.
HPLB was developed from an over-the-counter drug, Lactéol, which has been used for decades in more than 30 countries in support of oral rehydration in acute diarrhoea and to improve digestive comfort. Lactéol has an extensive safety record and has been studied in several clinical trials in which it has been shown to reduce digestive upset, improve abdominal comfort, reduce occasional bloating, and help achieve or maintain normal bowel movements.
In addition to effects on digestive health, recent preclinical studies on mice and dogs suggested that HPLB can also affect mood and stress, in line with the emerging concept that the intestinal microbiome may affect wellbeing.
In the present placebo-controlled, double blind clinical trial, the investigators therefore wish to test if daily supplementation with HPLB can reduce stress and improve wellbeing. This will be tested in older volunteers, because the risk of stress increases with age. Verum or placebo will each be administered daily for 12 weeks in capsules made from plant-based material which each also contain small amounts of a widely used flowing agent (magnesium stearate).
Additional endpoints of the trial relate to sleep quality, digestive health, and faecal microbiome composition.
- Conditions
- Stress
- Being tested
- Humiome Post LB, Microcrystalline Cellulose
- Keywords
- stress, wellbeing, healthy aging, postbiotic, microbiome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Humiome Post LBDietary supplement
Humiome Post LB is a postbiotic preparation according to the 2021 ISAPP definition (PMID: 33948025). It contains heat-treated co-fermented Limosilactobacillus fermentum (CNCM I-4831) and Lactobacillus delbrueckii ssp. lactis (CNCM I-4831), dried together with heat-treated spent fermentation medium on lactose as carrier.
Microcrystalline CelluloseOther
Also called MCC
MCC is typically sourced from wood pulp, or it can be chemically synthesized. It consists of linear chains of glucose, which are interlinked with β1,4-glycosidic bonds and cannot be broken by digestive enzymes. It is a very poor substrate for gut micro-organisms and is thus a good material to serve as placebo.
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Experimental | One-hundred participants will be randomized to the active treatment (verum) arm. Participants receive 2 capsules per day, taken simultaneously after breakfast, to provide a daily dose of 340 mg HPLB consistent with 10 billion heat-inactivated bacterial cell bodies. The opaque capsules are size 0 and produced from plant-based material (Hydroxy-Propyl Methyl Cellulose). Each capsule contains 2 mg Magnesium Stearate used as flowing agent for capsule filling. Receives: Dietary Supplement: Humiome Post LB |
| Placebo | Placebo comparator | One-hundred participants will be randomized to the control arm and will receive placebo. Participants receive 2 capsules per day, taken simultaneously after breakfast, to provide a daily dose of 340 mg microcrystalline cellulose. The opaque capsules are size 0 and produced from plant-based material (Hydroxy-Propyl Methyl Cellulose). Each capsule contains 2 mg Magnesium Stearate used as flowing agent for capsule filling. Receives: Other: Microcrystalline Cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is the Perceived Symtoms of Stress 10 (PSS10) questionnaire, which assesses perceived levels of stress
The PSS-10 questionnaire is a validated tool to assess self-reported levels of stress. It was originally developed in 1988 by Cohen and Williamson and published in "The social psychology of health" (pp. 31-67). S. Spacapan \& S. Oskamp (Eds.), Newbury Park, CA: Sage.
Measured: PSS-10 will be assessed at baseline and at study end, 12 weeks later
Secondary outcomes (6)
Perceived stress (PSS-10) after 6 weeks
Stress will also be assesed with the PSS-10 tool half-way through the intervention (6 weeks)
Measured: Week 6 of 12
Sleep quality after 6 and 12 weeks, assessed with the SHI (Sleep Hygiene Index) questionnaire
The SHI questionnaire is a likert-scale questionnaire developed in 2006 (Mastin, D. F., Bryson, J., \& Corwyn, R. (2006). Assessment of sleep hygiene using the Sleep Hygiene Index. Journal of Behavioral Medicine).
Measured: Baseline, week 6 and week 12 (study end)
Digestive health after 6 and 12 weeks
Digestive health will be assessed with the Gastrointestinal Symptom Rating Score questionnaire (GSRS). It is questionnaire with a 7-point Likert-scale (7 = most severe) with questions related to Reflux, Abdominal pain, Indigestion, Diarrhea and Constipation.
It was developed by Svedlund et al. (Svedlund J, Sjödin I, Dotevall G. GSRS - A Clinical Rating Scale For Gastrointestinal Symptoms in Patients With Irritable Bowel Syndrome and Peptic Ulcer Disease. Digestive Diseases and Sciences 1988; 33:129-134)
Measured: Baseline, week 6 and week 12
Depression, Anxiety and Stress
These are assessed with the DASS-21 questionnaire. It uses a 4-point Likert scale for 21 questions with 7 questions each in the field of depression, anxiety, and stress. It was developed by Lovibond et al. Lovibond, S. H., \& Lovibond, P. F. (1995). Manual for the Depression Anxiety Stress Scales. Sydney: Psychology Foundation of Australia.
Measured: Baseline, 6 and 12 weeks.
Stool frequencies
Mean daily number of bowel movements during the last 3 days before each visit. Recorded in a diary by each participant.
Measured: Assessed at baseline, week 6, and week 12
Stool consistency
Stool consistency is recorded with the Bristol Stool Scale as aid. The 7 point visual scale was developed in the UK by Stephen Lewis and Ken Heaton. Lewis, Heaton (1997). "Stool form scale as a useful guide to intestinal transit time". Scand. J. Gastroenterol. 32 (9): 920-924. It will be recorded in a diary for three days before each visit.
Measured: Baseline, week 6, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start1 Jan 2026
- Primary completionMay 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies 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
- Model description
- Randomized, double-blind, placebo-controlled parallel intervention trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- dsm-firmenich Switzerland AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Responsible party
- Sponsor
- Investigators
- Erik Eckhardt, PhD, Study director, dsm-firmenich Houdan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07471659
- Sponsor's protocol ID
- 2024-06-09-POST
- Acronym
- PostWelLB
- Status last verified
- Aug 2026
- First submitted
- 10 Mar 2026
- Last updated
- 2 Sep 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 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Placebo-controlled, Double-blind Clinical Trial to Evaluate the Efficacy of Three Months Daily Ingestion of Humiome® Post LB on Wellbeing in 50 - 75 Year-old Adults in France
- ClinicalTrials.gov ID
- NCT07471659
- Acronym / sponsor ID
- PostWelLB / 2024-06-09-POST
- Conditions
- Stress
- Keywords
- stress, wellbeing, healthy aging, postbiotic, microbiome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- dsm-firmenich Switzerland AGIndustry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 13 Mar 2026 (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.
The placebo-controlled, double blind parallel intervention trial "PostWelLB" aims to test whether 3 months of daily supplementation with the postbiotic product "Humiome® Post LB" (HPLB; 340 mg / day) can reduce self-reported stress (PSS10 questionnaire)- in an older (50 - 75 years; all genders) population in France.
Detailed description
The clinical study "PostWelLB" aims to test whether 3 months of daily supplementation with the postbiotic product "Humiome® Post LB" (HPLB) can reduce stress in an older population compared with placebo.
The investigational product (IP) HPLB is a postbiotic according to the International Scientific Association of Probiotics and Prebiotics (ISAPP), who defined postbiotics as "preparations of inanimate micro-organisms or components thereof that provide a health benefit on the host". In essence, HPLB is a fermentation product containing heat inactivated bacterial bodies of Limosilactobacillus fermentum (CNCM I-2998) and Lactobacillus delbrueckii (CNCM I-4831) and metabolite-rich spent fermentation medium (mainly lactic acid). The product also contains lactose, which is used as drying support.
HPLB was developed from an over-the-counter drug, Lactéol, which has been used for decades in more than 30 countries in support of oral rehydration in acute diarrhoea and to improve digestive comfort. Lactéol has an extensive safety record and has been studied in several clinical trials in which it has been shown to reduce digestive upset, improve abdominal comfort, reduce occasional bloating, and help achieve or maintain normal bowel movements.
In addition to effects on digestive health, recent preclinical studies on mice and dogs suggested that HPLB can also affect mood and stress, in line with the emerging concept that the intestinal microbiome may affect wellbeing.
In the present placebo-controlled, double blind clinical trial, the investigators therefore wish to test if daily supplementation with HPLB can reduce stress and improve wellbeing. This will be tested in older volunteers, because the risk of stress increases with age. Verum or placebo will each be administered daily for 12 weeks in capsules made from plant-based material which each also contain small amounts of a widely used flowing agent (magnesium stearate).
Additional endpoints of the trial relate to sleep quality, digestive health, and faecal microbiome composition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled parallel intervention trial
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Experimental | Dietary Supplement: Humiome Post LBOne-hundred participants will be randomized to the active treatment (verum) arm. Participants receive 2 capsules per day, taken simultaneously after breakfast, to provide a daily dose of 340 mg HPLB consistent with 10 billion heat-inactivated bacterial cell bodies. The opaque capsules are size 0 and produced from plant-based material (Hydroxy-Propyl Methyl Cellulose). Each capsule contains 2 mg Magnesium Stearate used as flowing agent for capsule filling. |
| Placebo | Placebo comparator | Other: Microcrystalline CelluloseOne-hundred participants will be randomized to the control arm and will receive placebo. Participants receive 2 capsules per day, taken simultaneously after breakfast, to provide a daily dose of 340 mg microcrystalline cellulose. The opaque capsules are size 0 and produced from plant-based material (Hydroxy-Propyl Methyl Cellulose). Each capsule contains 2 mg Magnesium Stearate used as flowing agent for capsule filling. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Men and women aged between 50 and 75 years old (limits included),
- Body mass index (BMI) ≥ 18.5 and < 30 kg/m²
- Presenting a level of psychological stress characterized by a PSS-10 score ≥ 14 and ≤ 26,
- For women: not at risk of pregnancy (as per definitions of Appendix 13) Participants currently of childbearing potential, using an effective method of contraception.
- Menopausal without hormone replacement therapy (estrogenic replacement therapy stopped since more than 3 months can be included)
Key exclusion criteria (22 listed)
- Suffering from a metabolic disorder such as treated or untreated diabetes,
- Suffering from thyroid dysfunction, high blood pressure or other metabolic disorders treated for less than 6 months and/or non-stabilized,
- Suffering from a severe chronic disease: cancer, HIV, renal failure, hepatic or biliary disorders ongoing (except for cholecystectomy since more than two years and asymptomatic), chronic inflammatory digestive disease, arthritis or other chronic respiratory trouble (except for mild asthma under treatment),
- Suffering from GI disorders found to be inconsistent with the conduct of the study by the investigator (e.g. celiac disease, Chron's disease, etc.),
- With a known food allergy or intolerance or hypersensitivity to any of the trial products' ingredients,
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 LBHumiome Post LB is a postbiotic preparation according to the 2021 ISAPP definition (PMID: 33948025). It contains heat-treated co-fermented Limosilactobacillus fermentum (CNCM I-4831) and Lactobacillus delbrueckii ssp. lactis (CNCM I-4831), dried together with heat-treated spent fermentation medium on lactose as carrier. | Dietary supplement | Active Treatment |
| Microcrystalline CelluloseAlso: MCCMCC is typically sourced from wood pulp, or it can be chemically synthesized. It consists of linear chains of glucose, which are interlinked with β1,4-glycosidic bonds and cannot be broken by digestive enzymes. It is a very poor substrate for gut micro-organisms and is thus a good material to serve as placebo. | Other | Placebo |
Primary outcome
The primary outcome measure is the Perceived Symtoms of Stress 10 (PSS10) questionnaire, which assesses perceived levels of stress
Time frame: PSS-10 will be assessed at baseline and at study end, 12 weeks later
The PSS-10 questionnaire is a validated tool to assess self-reported levels of stress. It was originally developed in 1988 by Cohen and Williamson and published in "The social psychology of health" (pp. 31-67). S. Spacapan \& S. Oskamp (Eds.), Newbury Park, CA: Sage.
6 secondary outcomes
Perceived stress (PSS-10) after 6 weeks
Time frame: Week 6 of 12
Sleep quality after 6 and 12 weeks, assessed with the SHI (Sleep Hygiene Index) questionnaire
Time frame: Baseline, week 6 and week 12 (study end)
Digestive health after 6 and 12 weeks
Time frame: Baseline, week 6 and week 12
Depression, Anxiety and Stress
Time frame: Baseline, 6 and 12 weeks.
Stool frequencies
Time frame: Assessed at baseline, week 6, and week 12
Stool consistency
Time frame: Baseline, week 6, week 12
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 2 Sep 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.
Erik Eckhardt, PhD study director
dsm-firmenich Houdan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Humiome Post LB and Microcrystalline Cellulose in people with Stress, run by dsm-firmenich Switzerland AG at 1 site in France.
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 12 inclusion and 22 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 2 Sep 2026. 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 France. 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 Eleonora Rossi, PhD (+33 240205799, eleonora.rossi@biofortis.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure is the Perceived Symtoms of Stress 10 (PSS10) questionnaire, which assesses perceived levels of stress (time frame: PSS-10 will be assessed at baseline and at study end, 12 weeks later). 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 2 Sep 2026.