A clinical trial to study the effect of Saccharomyces boulardii in acute childhood diarrhoea

Phase 3

• Conditions: acute childhood diarrhoea

• Registration Number: CTRI/2008/091/000255
• Lead Sponsor: mohd mushir reyaz

Brief Summary

this is an ongoing double blinded randomized controlled clinical trial to see the efficacy and safety of Saccharomyces boulardii(250 mg BD for 3days or till recovery whichever is earlier) in acute childhood diarrhoea.it is being conducted at pediatric ward ,jnmc,amu,aligarh ,india.primary outcome variable is duration of diarrhoea .The secondary outcome variable are rehydration time,frequency of loose stool&vomiting,ORS consumed,adverse drug reaction to S.boulardii

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

children age 3mths-5yrs with acute diarrhoea.

Exclusion Criteria

severe malnutrition ,systemic illness,encephalopathy,convulsion,feature of immunodeficiency,use of IV antibiotics.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
duration of diarrhoea	3 consecutive semi-formed stool or no stool in last 12 hours

Secondary Outcome Measures

Name	Time	Method
rehydration time ,ORS consumed,frequency of vomiting and diarrhoea,adverse drug reaction to S.boulardii	3 consecutive semiformed stool or no stool in last 12 hours

Trial Locations

Locations (1)

Pediatric ward(ward :16); 🇮🇳 Aligarh, UTTAR PRADESH, India

Pediatric ward(ward :16)

🇮🇳Aligarh, UTTAR PRADESH, India

mohd mushir reyaz

Principal investigator

09997497934

mushir_reyaz@yahoo.com