The Efficacy and Safety of a <italic>Bacillus</italic> Probiotic Combination for the Treatment of Acute Diarrhea in Children: A Double-blind, Randomized, Placebo-controlled Multicentric Study
Objective: Probiotics have been researched extensively over the past few years for the prevention and treatment of diarrhea in pediatric populations. In the present study, the efficacy and safety of probiotic <italic>Bacillus subtilis</italic> HU58 and probiotic <italic>Bacillus co...
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| Language: | English |
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Jaypee Brothers Medical Publisher
2022-08-01
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| Series: | Pediatric Infectious Disease |
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| Online Access: | https://www.pidjournal.com/doi/PID/pdf/10.5005/jp-journals-10081-1370 |
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| author | Ashish Ramchandra Dhongade Sanjay Sudhakar Joshi Suhas Venkatesh Kulkarni Shashank S Jadhav Neeta Nargundkar Deepak Deshmukh Anirudh Dilip Mehta |
| author_facet | Ashish Ramchandra Dhongade Sanjay Sudhakar Joshi Suhas Venkatesh Kulkarni Shashank S Jadhav Neeta Nargundkar Deepak Deshmukh Anirudh Dilip Mehta |
| author_sort | Ashish Ramchandra Dhongade |
| collection | DOAJ |
| description | Objective: Probiotics have been researched extensively over the past few years for the prevention and treatment of diarrhea in pediatric populations. In the present study, the efficacy and safety of probiotic <italic>Bacillus subtilis</italic> HU58 and probiotic <italic>Bacillus coagulans</italic> SC208 in combination were evaluated in children for the treatment of acute diarrhea.
Materials and Methods: In this randomized, double-blind, parallel, placebo-controlled trial, 64 children with average age of 4.18 ± 3.0 years (mean ± standard deviation), out of which 32 children with antibiotic-associated diarrhea (AAD) and 32 children with acute infective diarrhea randomly received either syrup containing <italic>B. subtilis</italic> HU58 and <italic>B. coagulans</italic> SC208 probiotics or placebo syrup daily for a period of 7 days. Stool consistency, duration of diarrhea in days, and abdominal pain intensity during the treatment period, were assessed daily in all subjects for the improvement in clinical signs and symptoms. Also, an assessment of adverse events was done from the screening visit to the end of study visit.
Result: A total of 32 subjects were screened and randomized in both cohort 1 and cohort 2. At the end of the study, that is, on day 7, <italic>B. subtilis</italic> HU58 + <italic>B. coagulans</italic> SC208 syrup-treated subjects in both cohorts showed significant improvement in stool consistency and duration of diarrhea over placebo syrup. No adverse events were observed in the study of both cohorts.
Conclusion: This study’s results conclude that <italic>B. subtilis</italic> HU58 and <italic>B. coagulans</italic> SC208 syrup improved the recovery and reduced the course of acute infectious diarrhea and AAD in children, with no reported adverse effects. |
| format | Article |
| id | doaj-art-a47e044fd3ae431a984af4eeca036314 |
| institution | DOAJ |
| issn | 2582-4988 |
| language | English |
| publishDate | 2022-08-01 |
| publisher | Jaypee Brothers Medical Publisher |
| record_format | Article |
| series | Pediatric Infectious Disease |
| spelling | doaj-art-a47e044fd3ae431a984af4eeca0363142025-08-20T03:18:20ZengJaypee Brothers Medical PublisherPediatric Infectious Disease2582-49882022-08-0143869110.5005/jp-journals-10081-13702The Efficacy and Safety of a <italic>Bacillus</italic> Probiotic Combination for the Treatment of Acute Diarrhea in Children: A Double-blind, Randomized, Placebo-controlled Multicentric StudyAshish Ramchandra Dhongade0Sanjay Sudhakar Joshi1Suhas Venkatesh Kulkarni2Shashank S Jadhav3Neeta Nargundkar4Deepak Deshmukh5Anirudh Dilip Mehta6Department of Pediatrics, Sant Dnyaneshwar Medical Education and Research Centre, Pune, Maharashtra, IndiaDepartment of Pediatrics, JMFS ACPM Medical College and Hospital, Dhule, Maharashtra, IndiaDepartment of Pediatrics, Chiranjeevi Hospital, Thane, Maharashtra, IndiaShashank S Jadhav, Synergia Life Sciences Pvt. Ltd., Mumbai, Maharashtra, India, Phone: +9122 6266 9600Biosphere Clinical Research Pvt. Ltd., Thane, Maharashtra, IndiaBiosphere Clinical Research Pvt. Ltd., Thane, Maharashtra, IndiaSynergia Life Sciences Pvt. Ltd., Mumbai, Maharashtra, IndiaObjective: Probiotics have been researched extensively over the past few years for the prevention and treatment of diarrhea in pediatric populations. In the present study, the efficacy and safety of probiotic <italic>Bacillus subtilis</italic> HU58 and probiotic <italic>Bacillus coagulans</italic> SC208 in combination were evaluated in children for the treatment of acute diarrhea. Materials and Methods: In this randomized, double-blind, parallel, placebo-controlled trial, 64 children with average age of 4.18 ± 3.0 years (mean ± standard deviation), out of which 32 children with antibiotic-associated diarrhea (AAD) and 32 children with acute infective diarrhea randomly received either syrup containing <italic>B. subtilis</italic> HU58 and <italic>B. coagulans</italic> SC208 probiotics or placebo syrup daily for a period of 7 days. Stool consistency, duration of diarrhea in days, and abdominal pain intensity during the treatment period, were assessed daily in all subjects for the improvement in clinical signs and symptoms. Also, an assessment of adverse events was done from the screening visit to the end of study visit. Result: A total of 32 subjects were screened and randomized in both cohort 1 and cohort 2. At the end of the study, that is, on day 7, <italic>B. subtilis</italic> HU58 + <italic>B. coagulans</italic> SC208 syrup-treated subjects in both cohorts showed significant improvement in stool consistency and duration of diarrhea over placebo syrup. No adverse events were observed in the study of both cohorts. Conclusion: This study’s results conclude that <italic>B. subtilis</italic> HU58 and <italic>B. coagulans</italic> SC208 syrup improved the recovery and reduced the course of acute infectious diarrhea and AAD in children, with no reported adverse effects.https://www.pidjournal.com/doi/PID/pdf/10.5005/jp-journals-10081-1370acute infective diarrheaantibiotic-associated diarrheabacillus coagulans sc208bacillus subtilis hu58bristol stool scale |
| spellingShingle | Ashish Ramchandra Dhongade Sanjay Sudhakar Joshi Suhas Venkatesh Kulkarni Shashank S Jadhav Neeta Nargundkar Deepak Deshmukh Anirudh Dilip Mehta The Efficacy and Safety of a <italic>Bacillus</italic> Probiotic Combination for the Treatment of Acute Diarrhea in Children: A Double-blind, Randomized, Placebo-controlled Multicentric Study Pediatric Infectious Disease acute infective diarrhea antibiotic-associated diarrhea bacillus coagulans sc208 bacillus subtilis hu58 bristol stool scale |
| title | The Efficacy and Safety of a <italic>Bacillus</italic> Probiotic Combination for the Treatment of Acute Diarrhea in Children: A Double-blind, Randomized, Placebo-controlled Multicentric Study |
| title_full | The Efficacy and Safety of a <italic>Bacillus</italic> Probiotic Combination for the Treatment of Acute Diarrhea in Children: A Double-blind, Randomized, Placebo-controlled Multicentric Study |
| title_fullStr | The Efficacy and Safety of a <italic>Bacillus</italic> Probiotic Combination for the Treatment of Acute Diarrhea in Children: A Double-blind, Randomized, Placebo-controlled Multicentric Study |
| title_full_unstemmed | The Efficacy and Safety of a <italic>Bacillus</italic> Probiotic Combination for the Treatment of Acute Diarrhea in Children: A Double-blind, Randomized, Placebo-controlled Multicentric Study |
| title_short | The Efficacy and Safety of a <italic>Bacillus</italic> Probiotic Combination for the Treatment of Acute Diarrhea in Children: A Double-blind, Randomized, Placebo-controlled Multicentric Study |
| title_sort | efficacy and safety of a italic bacillus italic probiotic combination for the treatment of acute diarrhea in children a double blind randomized placebo controlled multicentric study |
| topic | acute infective diarrhea antibiotic-associated diarrhea bacillus coagulans sc208 bacillus subtilis hu58 bristol stool scale |
| url | https://www.pidjournal.com/doi/PID/pdf/10.5005/jp-journals-10081-1370 |
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