Health Condition 1: - Health Condition 2: - Health Condition 3: null- Acute Diarrhea with Abdominal Discomfort and Flatulence.
Conditions
Interventions
Intervention1: Lactic Acid Bacillus: Pharmaceutical form: Powder
Dosing schedule in the study: 2 Billion colony forming unit by reconstituting in 100 ml water
twice-thrice daily prior to meal.
Control Intervention1: Placebo: Pharmaceutical form:Powder, Dosing schedule in the study: 2 Billion colony forming unit by reconstituting in 100 ml water
twice-thrice daily prior to meal
Sponsors
Advanced Enzymes Technologies Ltd
Eligibility
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Time To Last Unformed Stool (TTLUS) 2. Number of unformed stools produced from first IP administration to the end of treatment. 3. Change in severity of abdominal pain within 24 hours of starting the IP 4. Time to complete resolution of abdominal discomfort 5.Percentage change responders as defined by the number of subjects with complete remission of diarrhea within 48 hours 6. Number of subjects reporting reoccurrence of diarrhea symptoms within 120 hours Timepoint: Screening to End of Treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Quality of life 2. Assessment for safety 3. Assessment of rate of incidence of AE and SAEâ??s Timepoint: Screening to End of Treatment | — |
Countries
India
Contacts
Public ContactDr Harish s
ICBio Clinical Research Pvt. Ltd.
Outcome results
None listed