A Clinical Study to Evaluate the Effectiveness of Bacillus coagulans LBSC in the Treatment of Acute Diarrhea with Abdominal Discomfort and Flatulence.

Phase 2

Completed

• Conditions: Health Condition 1: - Health Condition 2: - Health Condition 3: null- Acute Diarrhea with Abdominal Discomfort and Flatulence.

• Registration Number: CTRI/2018/01/011635
• Lead Sponsor: Advanced Enzymes Technologies Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-03-11
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

1. Male and females aged more than 18 and less than 65 years completed years (both inclusive) with symptoms of acute diarrhea manifesting within 48 hours prior to entering the trial.

2. Subject having experienced at least three incidences of unformed stool (Type 7 by Bristol Stool form scale) within 48 hours prior to entering the trial (referring to any instances of watery stool or soft stool as determined after placing the stool in a container)

3. Subjects must have complaints of abdominal discomfort caused by gastrointestinal gas accumulation within the last hour

4. Written informed consent by study participants

Exclusion Criteria

1. Subjects requiring hospitalization for treatment of severe acute diarrhea or otherwise requires intravenous fluids or antibiotics on an outpatient basis

2. Subjects with bloody or purulent stool

3. Subjects having erythrocytes or leukocytes in the stool at more than 3 per high power field

4. Subjects having an axillary temperature greater than 38.2 degrees Celsius (C) or an oral temperature more than 38.6 degrees C

5. Subjects having other symptoms of septicemia.

6. Subjects unable to take medication orally or tolerate oral rehydration

7. Participant having a systolic blood pressure less than 90 millimeter of mercury (mmHg) and or diastolic blood pressure less than 60 mmHg in sitting posture

8. Subjects have gastric ulcer, duodenal ulcer, combined gastric and duodenal ulcers, upper gastrointestinal bleeding and GERD.

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

10. Use of any muscarine receptor antagonist and gastrin receptor antagonist within 2 weeks before initiating study IP therapy

11. Autoimmune gastritis

12.History of intubations for co morbidities (Chronic Lung Disease (CLD), Congenital Heart Defects (CHD), or neurologic disorders)

Study & Design

• Study Type: Interventional
• Study Design: Not specified