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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
200
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.
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.
Biofortis
Saint-Herblain, France
RECRUITINGThe 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.
Time frame: PSS-10 will be assessed at baseline and at study end, 12 weeks later
Perceived stress (PSS-10) after 6 weeks
Stress will also be assesed with the PSS-10 tool half-way through the intervention (6 weeks)
Time frame: 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).
Time frame: 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)
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: Baseline, week 6, week 12