Health Condition 1: K00-K95- Diseases of the digestive system
Conditions
Interventions
Intervention1: Bacillus clausii 088AE: 6 Billion colony forming unit per day
2 Billion CFU per sachet daily three times
Infants and Children 2 sachet per day
Adults 3 sachet per day
Method of admin
Sponsors
Advanced Enzyme Technologies Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and females aged >2 and 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Time to Last Unformed Stool (TTLUS) â?? At 24 h, 72 h, 120 h, 168 h & End. 2.Number of unformed stools at time points - At 24 h, 72 h, 120 h, 168 h & End â?? starting from first IP administration. 3.Time to complete resolution of functional gastrointestinal discomforts- At 24 h, 72 h, 120 h, 168 h & End 4.% responders as defined by the number of subjects with complete remission of diarrhea within 24 h, 72 h, 120 h, 168 h & End Timepoint: screening to end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 3.Tolerance 4.Assessment of safety of the Investigational products 5.Adverse event 6.Physical examination 7. Biomarker of systemic safety Timepoint: screening to end of treatment | — |
Countries
India
Contacts
Public ContactDr Harish S
ICBio Clinical Research Pvt. Ltd
Outcome results
None listed