No impact: Indian RCT finds probiotic Bacillus clausii has little impact on acute childhood diarrhoea
The research, published in the journal Tropical Diseases, Travel Medicine and Vaccines, contrasted past research findings, which showed that the probiotic could reduce stool frequency and disease duration in children with acute diarrhoea, alongside well-documented safety and tolerability levels.
“Childhood diarrhoea remains a major disease burden, particularly in developing countries, and is a leading cause of death in children aged five and below worldwide. Treatment of acute diarrhoea now includes probiotics to potentially reduce the duration and severity of the illness,” they said.
Diarrhoea in children may cause mortality, malnutrition, and cognitive and growth impairment. Hence, physicians have resorted to ORT to manage acute diarrhoea. ORT may be effective in replacing lost fluids and electrolytes, but it does not reduce the severity or duration of the disease.
Therefore, another recommended treatment is the usage of probiotics to nurture native gut flora and correct imbalances that may contribute to diarrheal diseases.
Hence, this latest double-blind, parallel-group RCT aimed to assess the efficacy and safety of the four strains – O/C, N/R, SIN and T – of B. clausii, supplemented with ORT and zinc.
Each subject was randomly assigned to one bottle of polyantibiotic-resistant B. clausii (an oral suspension of 2 billion spores per 5ml bottle) or a matching placebo. The placebo group was given an identical plastic vial containing water, in addition to ORT and zinc supplementation.
The team recruited 454 infants and children aged six months to five years old with acute moderate diarrhoea (more than 48 hours’ duration) across nine centres in India between December 2018 and March 2020.
Treatment was administered twice a day over five days. Subjects were hospitalised on Day One and discharged at least six hours after diarrhoea resolution or for a maximum of five days.
Patients were subjected to efficacy and safety assessments daily during hospitalisation, such as monitoring stool frequency and consistency, vital signs, hydration status and feeding patterns.
Similar proportions of patients showed recovery from diarrhoea over the 120-hour mark after randomisation, with 97% in the B. clausii group and 98% on placebo.
The median recovery time was similar at 42.83 hours for the B. clausii group and 42.13 hours for the placebo.
Treatment with B. clausii was well-tolerated, with the incidence of adverse events at 9.7%, which is almost similar to the placebo group at 12.3%.
The insignificant results could have been due to the strict exclusion criteria leading to inadequate sample size, mild to moderate severity and short duration of disease among subjects, and the delay of starting treatment as most subjects were already on the second day of the disease.
In conclusion, the researchers suggested conducting large multicentre studies incorporating lessons learned from this and other studies to fully comprehend the potential utility of B. clausii in viral, non-viral and antibiotic-associated diarrhoea in children.
“Community-based studies of preventive efficacy among children in deprived urban settings may also provide valuable public health insight,” said the researchers.
Source: Tropical Diseases, Travel Medicine and Vaccines
“Efficacy and safety of Bacillus clausii (O/C, N/R, SIN, T) probiotic combined with oral rehydration therapy (ORT) and zinc in acute diarrhea in children: a randomized, doubleblind, placebo-controlled study in India”
Authors: Keya Rani Lahiri et al