A multicentric, randomised, placebo controlled double blind study to compare safety and tolerability of Saccharomyces boulardii in acute diarrhoea
- Conditions
- Health Condition 1: null- Acute DiarrhoeaHealth Condition 2: R197- Diarrhea, unspecified
- Registration Number
- CTRI/2018/06/014480
- Lead Sponsor
- Alkem Laboratories Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Subjects aged between 6 months - 5 years of either gender presenting with acute diarrhea of <= 72 hours duration without history of intake of any antibiotic and without dehydration or with features of mild or moderate dehydration.
2.Parent or legal guardian of the subjects /subject must give written informed consent for study participation.
3.Parent of the subjects must follow all instructions as per the protocol
1.Subjects with clinical signs of dysentery, severe dehydration requiring hospitalization or parenteral fluid therapy.
2.Intake of any systemic antibiotic or any anti-diarrheal medication, in the previous 3 weeks prior to screening
3.Subjects who are debilitated or seriously ill or immunocompromised.
4.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.
5.Use of probiotics in the last 3 weeks prior to baseline visit.
6.Current use of any drugs or treatments which is supposed to decrease the gastrointestinal motility or any other concomitant anti-diarrheal medication.
7.Subjects who have undergone ileostomy, jejunostomy or colostomy
8.Subjects with hypersensitivity to any ingredient in the formulation.
9.Subjects with coexisting features of acute systemic disease like septicemia, meningitis, pneumonia etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Duration of diarrhea will be computed as time in hours after study product administration to the last abnormal (loose or liquid) stool preceding a normal stool output and the same would also be computed during the study period. Stool frequency will be noted as number of times the subject passes stool every day. Stool consistency will be evaluated on a 4 point Likert scale: 1- normal, 2- Loose, 3- semi-solid, 4 â?? liquid.Timepoint: 5 days
- Secondary Outcome Measures
Name Time Method Subjects in both groups will be followed up 3 months post intervention to compare the incidence of acute diarrheal episodes between the test and placebo group.Timepoint: 3 months;The assessment of the safety of the study medications will be evaluated by monitoring of both serious (SAE) and non-serious solicited and unsolicited adverse events during the study period. Assessment of tolerability will be done by the physician on a 4 point Likert Scale 1- excellent, 2- good, 3- fair, 4- poor.Timepoint: 5 days