Health Condition 1: null- Acute Diarrhoea
Conditions
Interventions
Intervention1: Bacillus clausii UBBC07 ( BACIPRO) Oral Suspension: Bacillus clausii ( BACIPRO) Oral Suspension containing
Bacillus clausii UBBC07 - 2 billion cfu/ 5ml suspension
Dosage: 5ml twi
Sponsors
Unique Biotech Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Children aged between >=6 months and 2.Subjects with clinical diagnosis of acute diarrhoea. 3.Subjects who experienced more than 3 loose stools in the last 24 hours 4.Subjects with no major illness. 5.Parents of the subjects willing to give written informed Consent & willing to follow study procedures. 6.Informed Consent form signed by the subjectâ??s parent/Legally Acceptable Representative or an impartial witness
Exclusion criteria
Exclusion criteria: 1.Children with severe malnutrition (weight for height 2.Subjects requiring antibiotics during the study period. 3.Presence of severe diarrhoea which, in the opinion of the investigator, requires treatment other than investigational product and ORS. 4. Presence of visible blood in the stool. 5.Use of probiotics in the previous three weeks, use of antibiotics or any antidiarrhoeal medication in the previous three weeks. 6.Participated in any clinical trial or used any investigational product in the past 90 days. 7.Known or expected hypersensitivity to any of the active substances or excipients. 8.Previous use (within 48 hours) of kaolin, pectin, bismuth subsalicylate, racecadotril, loperamide, atropine and other anticholinergic agents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Number and Frequency of diarrhoea episodes post-therapy. 2) Duration of diarrhoea episodes post-therapy 1) Number and Frequency of diarrhoea episodes post-therapy. 2) Duration of diarrhoea episodes post-therapy. 3) Consistency of stool Timepoint: Baseline, 5th day, 10th day | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Clinical Global Impression-Improvement (CGI-I) by Investigator. 2) Number, frequency and duration of vomiting episodes 3) Number of Fever episodes. 4)Assessment of gut microbiota before and after treatment with probiotic 5)Number and frequency of hospital admissions required Timepoint: Baseline, 5th day, 10th day | — |
Countries
India
Contacts
Public ContactDr N Jayanthi
Abiogensis Clinpharm Pvt Ltd
Outcome results
None listed