Health Condition 1: K528- Other specified noninfective gastroenteritis and colitis
Conditions
Interventions
Intervention1: BACIPRO vials: Bacillus clausii UBBC-07 suspension in water (2x10 riased to 9 CFU per 5ml vial) in 5 ml twice a day
Control Intervention1: Placebo: RO water in 5 ml twice a day
Sponsors
Unique Biotech Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: Outpatients with a proven or suspected infection anticipated to be treated on physicians prescribed amoxicillin+ clavulanate or other combinations with amoxicillin.Willing to give written informed consent/assent
Exclusion criteria
Exclusion criteria: 1.Subject with history of o Prior use of antibiotics within the previous 6 weeks. o Presence of a severe or generalised infection. o Severe chronic disease. o Pre-existing diarrhoea within the previous 4 weeks. 2.Patients with bloody or purulent stool, with pus or mucus. 3.Severe dehydration needing hospitalization. 4.Infants on exclusive breastfeeding 5.Requiring hospitalization 6.An axillary temperature greater than 38.2°C or an oral temperature greter than 38.6°C. 7.Symptoms of septicaemia 8.Subjects having hypersensitivity or history of allergy to any component of the study product. 9. Unable to take medication orally or tolerate oral rehydration. 10.Taken probiotics prior to study (2 months) or during study other than interventional product. 11.History of gastric ulcer, duodenal ulcer, combined gastric and duodenal ulcers, upper gastrointestinal bleeding, autoimmune gastritis and GERD. 12.Use of any proton pump inhibitor, sucralfate, H2-receptor antagonist, or bismuth preparations or any muscarine receptor antagonist and gastrin receptor antagonist within 2 weeks before initiating study IP therapy. 13.History of intubations for co-morbidities like, chronic lung disease (CLD), congenital heart defects (CHD) or neurologic disorders. 14.Use of any other investigational drug currently or within 30 days prior to study entry. 15.Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study. 16.Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the incidence of antibiotic-associated diarrhoea assessed in the investigational product arm compared to placebo.Timepoint: Day 1, Day 7, Day 15 and Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the efficacy parameters assessed in the investigational product arm compared to placebo at a defined time points in comparison to baselineTimepoint: Day 1, Day 7, Day 15 and Day 30;Fecal microbiota analysisTimepoint: Day 1 and Day 30 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd
Outcome results
None listed