Health Condition 1: R197- Diarrhea, unspecified
Conditions
Interventions
Intervention1: Probiotic Bacillus subtilis HU58 and Bacillus coagulans SC208 Syrup: 5 ml of syrup to be given once
a day orally for 7 days
The dose will be increased to twice daily at visit 3 (Day 3
Sponsors
Synergia Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or Female subjects between �1 to � 12years of age both inclusive. 2. The investigator believes that the parent(s) or Legally Acceptable Representative(s) (LAR(s)) of the child will comply with the requirements of the protocol. 3. Written informed consent /assent obtained from the parent(s)/LAR(s) of the subject and the subject respectively for participation in the study. Cohort 1: 1. Subjects undergoing treatment with antibiotics irrespective of indication and the type of antibiotics. 2. Subject suffering from Antibiotic-associated Diarrhoea defined as passage of three or more liquid or watery stools occurring in a 24-hour period. Cohort 2: 1. Subject with clinical diagnosis of acute infective diarrhoea defined as passage of three or more liquid or watery stools occurring in a 24-hour period and lasting for less than three days).
Exclusion criteria
Exclusion criteria: 1. History of pre-existing diarrhoea within the previous 4 weeks. 2. Subjects requiring hospitalisation. 3. Subjects with Severe dehydrationrequiring intravenous rehydration. 4. Subjects with bloody and/or purulent stools 5. Subjects with symptoms or suspicion of an organic lesion of the digestive tract, or with undiagnosed abdominal pain or rectal bleeding or other GI disorder especially ulcerative colitis, Crohnââ?¬Ë?s disease, history of carcinomas of the bowel, malabsorption syndrome, intolerance to certain food types (lactose), functional diarrhoea and functional constipation. 6. Subjects with gastrointestinal surgery. 7. History of severe chronic systemic diseases, critical/life-threatening illness or immunodeficiency diseases. 8. Known hypersensitivity to any of the ingredients in the probiotic product or the placebo. 9. Use of proton-pump inhibitors, laxatives or anti-diarrhoeal drugs, as well as use of a probiotic 14 days before and during the study 10. Participation in another clinical study within 30 days before the beginning or anytime during the duration of the current clinical study. 11. Any other condition which, in the opinion of the Investigator, prevents the child from participating in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Stool consistency (as assessed by Bristol Stool Scale (BSS)[ including 7 types as follows: type 1 to 2 indicates constipation; type 3 to 5 suggests normal stools; and type 6 to 7 means liquid stool] 2.Duration of diarrhoea in days (time between the start of treatment until last diarrheal/watery stool before recovery or end of study treatment).Timepoint: 7 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| Abdominal pain intensity [as measured by visual analogue scale (VAS)].Timepoint: 7 Days;The assessment of safety of Investigational Product will be based on the frequency of Adverse Events and changes in laboratory values. All safety variables will be summarized using descriptive statisticsTimepoint: 7 Days | — |
Countries
India
Contacts
Public ContactDr Shashank S Jadhav
Biosphere Clinical Research Pvt.Ltd
Outcome results
None listed