Effect of the probiotic strain, Lactiplantibacillus plantarum P9, on chronic constipation: A randomized, double-blind, placebo-controlled study.

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• This study suggested that P9-associated constipation symptom relief was not attributed to macroscopic changes in the host gut bacteriome and phageome
• However, results supported that taking P9 could alleviate constipation, with the symptom relief effects linked to desired changes and interactions with different types of host microbes, including the gut commensal bacteria (L. plantarum, Ruminococcus_B gnavus, Oscillospiraceae sp., Lachnospiraceae sp.) and the bacteriophage family, Herelleviridae.

Introduction

This study investigated the effect of a specific probiotic strain in alleviating Chronic Constipation (CC).

Methods

• The study employed a 42-day randomised control trial (RTC) double-blind, placebo-controlled design, with 163 patients, (mean age =22.68 ±5.66 years for the probiotic group and 21.59 ±4.59 years for the placebo group), diagnosed with CC (Rome IV criteria)
• The male to female ratio was 15–63 and 17–68 in probiotic and placebo groups respectively
• Groups were standardised with no differences observed in baseline age, gender ratio, drug treatment, high-fibre diet and smoking between the two groups (P >0.18)
• Participants were randomly assigned to the probiotic Lactiplantibacillis plantarum P9 (n=78; 2 g per sachet, 1 ×1011 CFU/day) or the placebo (n =85; maltodextrin powder) groups.

Results

Primary outcomes: weekly mean complete spontaneous bowel movements (CSBMs):

• At 28-days CSBM was 28% higher in the P9 group (P=0.039) compared with the placebo group
• At 42-days CSBM remained significantly higher in the P9 group (P=0.026) compared with the placebo group, and increased 2-fold compared with baseline (P <0.05)
• Authors noted that the CSBM benefits were maintained even after 14 days of not taking the supplement.

Secondary outcomes: The effects of P9 supplementation on constipation-related parameters, including the weekly mean frequency of spontaneous bowel movements (SBMs) demonstrated:

• After 28-days of P9 supplementation, SBMs were 12% higher than the placebo group (P=0.039)
• No differences were observed in the weekly mean stool consistency and straining scores between groups (P>0.05).

Patients’ quality of life and psychological state, using a PAC-QOL questionnaire related to: worries and concerns (WO), physical discomfort, psychosocial discomfort, and satisfaction and found:

• At day 14 WO in the P9 group was 1.22-fold lower than those in the placebo group (P <0.05)
• No differences in the other 3 items between P9 and placebo groups (P >0.05) were observed
• Supplementation resulted in a significant change in relative abundance of the P9 genome (≥0.01%)
• However, no differences were observed in alpha diversity after P9 consumption compared with placebo.

Conclusion

• The results indicated that P9 administration alleviated patients’ constipation symptoms and improved their quality of life but did not impact on gut bacteria or phageome
• Lactiplantibacillis plantarum P9 supplementation impacted several beneficial bacteria species (e.g. (Lactiplantibacillus plantarum and Ruminococcus_B gnavus), and reduced levels of other bacteria and phage taxa (e.g. Oscillospiraceae sp., Lachnospiraceae sp., and Herelleviridae) which may be implicated in constipation relief mechanisms.

• In this study, the use of P9 administration significantly improved patients’ defecation frequency which could have beneficial implications for patients suffering from chronic constipation
• Probiotic effects are known to be strain- and host-specific, and based on this study P9 administration for relief of constipation needs to be taken for at least two weeks to improve aspects of patients’ quality of life and 4 weeks for improvements in constipation.

• Future trials should include factors that impact gut motility and constipation symptoms, such as: a detailed daily diet (dietary composition, fibre content, and water intake) and physical activity scale (intensity and duration), and longer term use of P9 or comparison across strains
• The relatively small study size and short duration of this study, as well as the younger age groups included may be pertinent when considering future research.