Effect of probiotic Bacillus clausii UBBC07 in children with Acute Diarrhoea
- Conditions
- Acute Diarrhoea
- Registration Number
- CTRI/2017/08/009543
- Lead Sponsor
- Unique Biotech Ltd
- Brief Summary
This is a prospective,double-blind, multicentric, randomized, parallel-group study to evaluate thecomparable safety and efficacy of *Bacillusclausii* UBBC07 suspension (2 billion cfu/5 mL)over placebo for treatment of acute diarrhoea in children of age six months tofive years. In all, 120 subjects will be randomized by blockrandomization technique in order to enroll subjects in a targeted ratio of 1:1(test: placebo). Test group and placebo group will have approximately equalnumber of subjects in the age groups of 6 months to 5 years. Subjects who hadexperienced >3 loose stools in last 24 hours will be randomized to receiveeither test or placebo product. The IP will be administered for a period offive days.
Subjects will be evaluatedfor the frequency and duration of diarrhoea,consistency of stools (primary efficacy parameters), vomiting, fever and anyhospital admissions required and on Clinical GlobalImpression-Improvement (CGI-I) scale by the investigator and assessment of gutmicrobiota before and after treatment with probiotic (secondary parameters).
Stool consistency will beassessed by Bristol Stool Form scale which categorizes the stool in to seventypes. CGI-I will be evaluated on the 7-point scale.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 120
- 1.Children aged between ≥6 months and ≤5 years 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 subject’s parent/Legally Acceptable Representative or an impartial witness.
- 1.Children with severe malnutrition (weight for height < 3 SD of WHO charts).
- 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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Number and Frequency of diarrhoea episodes post-therapy. Baseline, 5th day, 10th day 2) Duration of diarrhoea episodes post-therapy Baseline, 5th day, 10th day 2) Duration of diarrhoea episodes post-therapy. Baseline, 5th day, 10th day 3) Consistency of stool Baseline, 5th day, 10th day
- Secondary Outcome Measures
Name Time Method 1) Clinical Global Impression-Improvement (CGI-I) by Investigator. 2) Number, frequency and duration of vomiting episodes
Trial Locations
- Locations (2)
KRM Hospital & Research Centre
🇮🇳Lucknow, UTTAR PRADESH, India
M V Hospital and Research Centre
🇮🇳Lucknow, UTTAR PRADESH, India
KRM Hospital & Research Centre🇮🇳Lucknow, UTTAR PRADESH, IndiaDr A K VermaPrincipal investigator9839089844krmhrclko@gmail.com