Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 4:12 AM
Study NCT ID:
NCT07471659
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-13
First Post:
2026-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Daily Humiome® Post LB Intake on Wellbeing in Older Individuals With Moderate Stress Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'C109691', 'term': 'microcrystalline cellulose'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, double-blind, placebo-controlled parallel intervention trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-10', 'studyFirstSubmitDate': '2026-03-10', 'studyFirstSubmitQcDate': '2026-03-10', 'lastUpdatePostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Gut Microbiome diversity and function after 6 and 12 weeks', 'timeFrame': 'Baseline and weeks 6 and 12', 'description': 'DNA from fecal samples will be shotgun-sequenced (Illumina Hiseq 150 x2) and taxonomic (alpha and beta-diversity) and functional composition assessed by aligning functional gene copy numbers with known database (Kegg). The gut metabolomic profile will be analysed using semi-polar LC-MS / MS methods to detect the abundance of metabolites known or hypothesized to be involved in stress such as GABA, serotonin or melatonin. The faecal organic acids (acetate, propionate, butyrate, valerate, lactate) will be analysed by a targeted quantitative SCFA method (GC-MS).'}], 'primaryOutcomes': [{'measure': 'The primary outcome measure is the Perceived Symtoms of Stress 10 (PSS10) questionnaire, which assesses perceived levels of stress', 'timeFrame': 'PSS-10 will be assessed at baseline and at study end, 12 weeks later', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Perceived stress (PSS-10) after 6 weeks', 'timeFrame': 'Week 6 of 12', 'description': 'Stress will also be assesed with the PSS-10 tool half-way through the intervention (6 weeks)'}, {'measure': 'Sleep quality after 6 and 12 weeks, assessed with the SHI (Sleep Hygiene Index) questionnaire', 'timeFrame': 'Baseline, week 6 and week 12 (study end)', 'description': '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).'}, {'measure': 'Digestive health after 6 and 12 weeks', 'timeFrame': 'Baseline, week 6 and week 12', 'description': '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.\n\nIt 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)'}, {'measure': 'Depression, Anxiety and Stress', 'timeFrame': 'Baseline, 6 and 12 weeks.', 'description': '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.'}, {'measure': 'Stool frequencies', 'timeFrame': 'Assessed at baseline, week 6, and week 12', 'description': 'Mean daily number of bowel movements during the last 3 days before each visit. Recorded in a diary by each participant.'}, {'measure': 'Stool consistency', 'timeFrame': 'Baseline, week 6, week 12', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stress', 'wellbeing', 'healthy aging', 'postbiotic', 'microbiome'], 'conditions': ['Stress']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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" (Salminen et al., 2021; PMID 33948025). 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.\n\nHPLB 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 (Liévin-Le Moal, 2016; PMID 26770268).\n\nIn addition to effects on digestive health, recent preclinical studies on mice (Warda et al., 2019; PMID 30597248) and dogs (Koziol et al., 2023; PMID 37208000) suggested that HPLB can also affect mood and stress, in line with the emerging concept that the intestinal microbiome may affect wellbeing (Foster et al., 2017; PMID 29276734).\n\nIn the present placebo-controlled, double blind clinical trial, we therefore wish to test if daily supplementation with HPLB can reduce stress and improve wellbeing. We wish to test this in older volunteers, because the risk of stress increases with age (Lavretsky \\& Newhouse, 2012; PMID 22874577). 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).\n\nAdditional endpoints of the trial relate to sleep quality, digestive health, and faecal microbiome composition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "INCLUSION CRITERIA:\n\nMen 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 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.\n\nEXCLUSION CRITERIA:\n\nSuffering 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, 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."}, 'identificationModule': {'nctId': 'NCT07471659', 'acronym': 'PostWelLB', 'briefTitle': 'Effect of Daily Humiome® Post LB Intake on Wellbeing in Older Individuals With Moderate Stress Levels', 'organization': {'class': 'INDUSTRY', 'fullName': 'dsm-firmenich Switzerland AG'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '2024-06-09-POST'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Treatment', 'description': '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.', 'interventionNames': ['Dietary Supplement: Humiome Post LB']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '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.', 'interventionNames': ['Other: Microcrystalline Cellulose']}], 'interventions': [{'name': 'Humiome Post LB', 'type': 'DIETARY_SUPPLEMENT', 'description': '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.', 'armGroupLabels': ['Active Treatment']}, {'name': 'Microcrystalline Cellulose', 'type': 'OTHER', 'otherNames': ['MCC'], 'description': '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.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44800', 'city': 'Saint-Herblain', 'country': 'France', 'contacts': [{'name': 'Eleonora Rossi, PhD', 'role': 'CONTACT', 'email': 'eleonora.rossi@biofortis.fr', 'phone': '+33 240205799'}, {'name': 'Sahara Graf', 'role': 'CONTACT', 'email': 'sahara.graf@biofortis.fr', 'phone': '+33 240205799'}], 'facility': 'Biofortis', 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}], 'centralContacts': [{'name': 'Eleonora Rossi, PhD', 'role': 'CONTACT', 'email': 'eleonora.rossi@biofortis.fr', 'phone': '+33 240205799'}, {'name': 'Erik Eckhardt, PhD', 'role': 'CONTACT', 'email': 'erik.eckhardt@dsm-firmenich.com', 'phone': '+33 659328475'}], 'overallOfficials': [{'name': 'Erik Eckhardt, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'dsm-firmenich Houdan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'dsm-firmenich Switzerland AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'BioFortis', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}