Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07471659
Brief 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.
Study:
NCT07471659
Study Brief:
Protocol Section:
NCT07471659