Clinical Study to Evaluate the Efficacy and Safety of Bacillus clausii (probiotic) in the Treatment of Antibiotic Associated Diarrhoea

Phase 3

Completed

• Conditions: Diseases of the digestive system,

• Registration Number: CTRI/2020/03/023936
• Lead Sponsor: Advanced Enzyme Technologies Ltd

Brief Summary

A Prospective, Interventional, Randomized, Double blind, Parallel, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of *Bacillus clausii* 088AE in the Treatment of Antibiotic-Associated Diarrhoea.

Total 120 subjects

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|1. Placebo Pediatric AAD (n=30 randomized) [Pediatric; Age group: 2-10 Years] 2.    Test Pediatric AAD (n=30 randomized) [Pediatric; Age group: 2-10 Years] 3.    Placebo adolescent & Adult AAD (n=30 randomized) [Adolescent & adult; Age group: 11-up to 65 Years] 4.    Test adolescent & Adult AAD (n=30 randomized)    [Adolescent & adult; Age group: 11-up to 65  Years]

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-24
• Study Completion: 2020-07-10
• Last Update Posted: 2020-11-24

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1.Male and females aged >2 and <65 years completed years (both inclusive) with symptoms of antibiotic treatment induced diarrhea manifesting within at least 48 hours or more than prior to entering the trial 2.Patients having experienced at least three incidences of unformed stool (Type 7 by Bristol Stool form scale) within at least 48 hours or more than prior to entering the trial 3.Patients with diarrhea induced due to ongoing antibiotic therapy (Patients should be on the initial 4 days of antibiotic therapy which is given for at least for 14 days 4.Patient must have complaints of related gastrointestinal disorders caused by various abdominal discomforts within the last hour 5.Willing to give written informed consent or assent form by study participants or parent wherever applicable.

Exclusion Criteria

• 1.Patients with bloody or purulent stool, with pus or mucus.
• 2.Severe dehydration needing hospitalization.
• 3.An axillary temperature greater than (>) 38.2°C or an oral temperature > 38.6°C 4.Symptoms of septicemia (Fever, shivering, or feeling cold, fast heart rate, fast breathing and shortness of breath, sweaty or clammy skin, etc.) 5.Unable to take medication orally or tolerate oral rehydration.
• 6.Taken probiotics prior to study (2 weeks) or during study other than interventional product.
• 7.History of gastric ulcer, duodenal ulcer, combined gastric and duodenal ulcers, upper gastrointestinal bleeding, autoimmune gastritis and GERD.
• 9.Use of any muscarine receptor antagonist and gastrin receptor antagonist within 2 weeks before initiating study IP therapy.
• 10.History of intubations for co-morbidities (chronic lung disease (CLD), congenital heart defects (CHD) or neurologic disorders.
• 11.Use of any investigational drug currently or within 30 days prior to study entry.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Time to Last Unformed Stool (TTLUS) – At 24 h, 72 h, 120 h, 168 h & End.	screening to end of treatment
2.Number of unformed stools at time points - At 24 h, 72 h, 120 h, 168 h & End – starting from first IP administration.	screening to end of treatment
4.% responders as defined by the number of subjects with complete remission of diarrhea within 24 h, 72 h, 120 h, 168 h & End	screening to end of treatment
3.Time to complete resolution of functional gastrointestinal discomforts- At 24 h, 72 h, 120 h, 168 h & End	screening to end of treatment

Secondary Outcome Measures

Name	Time	Method
1.To evaluate the changes of the severity of AAD related symptoms	2.To evaluate the changes in VAS score of AAD at 24 h, 72 h, 120 h, 168 h & End

Trial Locations

Locations (2)

Rajalakshmi Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Sai hospital pune; 🇮🇳 Pune, MAHARASHTRA, India

Rajalakshmi Hospital

🇮🇳Bangalore, KARNATAKA, India

Dr Giriraja K V

Principal investigator

9738877298

drgirirajkv@gmail.com