Health Condition 1: K598- Other specified functional intestinal disorders
Conditions
Interventions
Intervention1: Bacillus subtilis HU58 syrup: 5 ml once a day for 7 Days
Control Intervention1: Placebo Syrup
: 5 ml once a day for 7 Days
Sponsors
Synergia Lifesciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children aged 1 to 12 years. 2. Children undergoing treatment with antibiotics irrespective of indication and type of antibiotics. 3. AAD defined as passage of three or more liquid or watery stools occurring in a 24-hour period. 4. Children and Parents willingness to participate in the clinical study and willing to give informed consent/assent.
Exclusion criteria
Exclusion criteria: 1. History of pre-existing diarrhea within the previous 4 weeks. 2. Subjects requiring hospitalization. 3. Subjects with severe dehydration requiring 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, Crohnâ??s disease, history of carcinomas of the bowel, malabsorption syndrome, intolerance to certain food types (lactose), functional diarrhea 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 |
|---|---|
| The primary outcome evaluates Stool consistency as assessed by Bristol Stool Scale (BSS), GI Restoration Questionnaire, Physicians Global Assessment and duration of diarrhea in days Timepoint: Day 1, Day 3 and Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| secondary outcome evaluates abdominal pain intensity as assessed by the visual analogue scale from baseline to end of studyTimepoint: Day 1, Day 3 and Day 7 | — |
Countries
India
Contacts
Public ContactMr Sohal Pendse
ProRelix Research
Outcome results
None listed