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

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 × 10⁹ CFU/Cap) or placebo for 7 days and followed up to 15^th day. Stool consistency was recorded during the baseline, 3rd day, 7^th day and 15^th 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 15^th day. There was no reduction of score in the placebo group (scale 7) till the 15^th 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 × 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.