A Study of Probiotic Bacillus subtilis HU58 for the Management of Antibiotic-Associated Diarrhoea in Adults

Dr Dilip Mehta, de Souza A, Jadhav SS, Devale M

Dr Dilip Mehta, de Souza A, Jadhav SS, Devale M

Keywords: Probiotic Bacillus subtilis HU58, Antibiotic Associated Diarrhoea (AAD),, Colony Forming Units (CFU), Bristol Stool Chart, Stool consistency

Abstract

Aim: To evaluate the effectiveness of a novel probiotic Bacillus subtilis HU58 in an open-labelled placebo-controlled
trial in a group of 60 patients with Antibiotic Associated Diarrhoea (AAD).
Materials and Methods: The study was conducted in 60 patients suffering from AAD. Patients received either
Probiotic Bacillus subtilis HU58 (2 X 109 CFU/Cap) or placebo for 7 days and followed up to 15th day. Stool
consistency was recorded during the baseline, 3rd day, 7th day and 15th day and analyzed according to the Bristol
stool chart. The trial was approved by an Independent Ethics Committee and registered with CTRI. Before
enrolment, an informed written consent was obtained from the patients.
Results: Stool consistency as assessed according to the Bristol stool chart had decreased in the probiotic
treated group (p<0.0001) as compared to the placebo group (p=0.8003). At baseline the stool consistency measurements
according to the Bristol stool chart in both groups (probiotic group and placebo group) were found
to be 7. The stool frequency had reduced from 7-8 stools per day to 1-2 stools per day. Significant improvement
was observed in 16 patients (scale 4), mild improvement observed in 6 patients (scale 5) and no improvement
was observed in 8 patients (scale 6) as observed till the 15th day. There was no reduction of score in the placebo
group (scale 7) till the 15th day. Also the stool frequency in this group had just reduced from 7-8 stools to 3-4
stools per day.
Conclusions: This study had shown that Probiotic Bacillus subtilis HU58 at a dose of 2 X 109 CFU/Cap once a
day for 7 days was well tolerated and safe and compared to placebo the probiotic group significantly showed a
reduced incidence of AAD.
Conflict/s of Interest: Dr. Dilip Mehta, Dr. Anselm de Souza and Dr. Shashank Jadhav are CEO, Managing Director
and Med. Director from Synergia Life Sciences Pvt. Ltd. respectively.
Source/s of Support: Synergia Life Sciences funded this study.

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