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

Phase 3

Completed

• Conditions: Health Condition 1: K00-K95- Diseases of the digestive system

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-10-07
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• 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.

8.Use of any proton pump inhibitor, sucralfate, H2-receptor antagonist, or bismuth preparations within 1 week before initiating study IP therapy.

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