Normalization of bowel movement frequency following four weeks ingestion of the postbiotic Humiome® Post LB in healthy Japanese adults with high self-reported bowel movement frequency
Objective
The objective of this placebo-controlled, randomized, double blind, parallel group intervention trial was to test if daily administration of HPLB for 4 weeks would normalize bowel-movement frequency in a healthy Japanese cohort of adult individuals with high self-reported bowel movement frequency.
Method
One hundred Japanese volunteers with self-reported bowel movement frequency between 10 and 20 per week in the week before the study start were randomized to receive 170 mg HPLB twice daily (20 billion inanimate cell bodies per day) or placebo for 4 weeks. Bowel movements and stool scores were recorded daily. Fecal samples were taken at start (T0) and end (T4) of the study. The primary endpoint was stool frequency over the last week. Secondary endpoints included average days per week with at least one bowel movement, fecal scoring, and microbial alpha diversity at T4 versus T0.
Results
In the HPLB group, average daily bowel movements dropped from 12.3 ± 2.2 (S.D.) in the week prior to intervention to 7.4 ± 3.3 in the last week (n=50). In the placebo group, they dropped from 12.5 ± 2.5 to 8.7 ± 3.5 (n=47; between-group difference in the last week was statistically significant; P=0.029). HPLB also led to a significant reduction versus placebo in the number of days with at least one bowel movement after weeks 3 and 4 (secondary endpoint). Microbiome diversity (Shannon index) tended to be higher in the HPLB group at T4 compared to placebo (P=0.053).
Conclusion
Four weeks of ingestion of Humiome® Post LB may help reduce high bowel movement frequency compared to placebo in healthy individuals with self-reported high numbers of bowel movements. The observed trend towards higher microbial diversity with Humiome® Post LB versus placebo suggests that the effect is related to microbiome modulation.
Clinical Trial Registration - The trial (UMIN-CTR registration UMIN000051486) was approved by the Seishinkai Medical Corporation Takara Clinic Ethics Committee (Approval number: 2306-00218-0106-12-TC)