NCT07471659

Effect of Daily Humiome® Post LB Intake on Wellbeing in Older Individuals With Moderate Stress Levels

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: dsm-firmenich Switzerland AG · Industry
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Accepted

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.

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" (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. 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 (Liévin-Le Moal, 2016; PMID 26770268). In 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). In 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). Additional endpoints of the trial relate to sleep quality, digestive health, and faecal microbiome composition.

Conditions

• Stress

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Humiome Post LB	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.
OTHER	Microcrystalline Cellulose	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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-11-01
• Completion: 2026-12-01
• First posted: 2026-03-13
• Last updated: 2026-03-13

Locations

1 site across 1 country: France