Probiotics for infectious diarrhea in children in south India

Phase 1

Completed

• Conditions: Health Condition 1: null- Infectious Gastroenteritis

• Registration Number: CTRI/2010/091/000339
• Lead Sponsor: Christian Medical College Vellore

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 160

Inclusion Criteria

Male and female children aged 6 months to 5 years
Diagnosis of rotaviral or cryptosporidial gastroenteritis (Rotavirus or Cryptosporidium EIA positive and three or more watery stools within a 24-hour period)
No other enteric pathogen isolated from the stool at the time of enrollment
?Able to take the contents of study capsules mixed into food or milk
?No need for antibiotics for current illness
No use of LGG/other probiotics within 30 days (yogurt consumption is not an exclusion criterion)
HIV negative
No severe malnutrition (WAZ score < 3SD below the median)
No evidence of active bowel leak, acute abdomen or colitis
No history of allergy
Parent/guardian willing to report on compliance and side effects during the study period
Families willing to provide informed consent, participate in study and have study personnel visit their home.

Exclusion Criteria

Other enteric pathogens isolated from the stool at the time of enrollment

Not willing or able to take the contents of study capsules mixed into food or milk

Need for antibiotics for current illness

HIV positive

Severe malnutrition (WAZ score < 3SD below the median)

Presence of active bowel leak, acute abdomen or colitis

?History of allergy

Parent/guardian not willing to report on compliance and side effects during the study period

Families not willing to provide informed consent, participate in study or have study personnel visit their home.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IgG to rotavirus VP6 or cryptosporidial g15 at 4 weeksTimepoint: 4 weeks

Secondary Outcome Measures

Name	Time	Method
actulose:mannitol test at 4 weeksTimepoint: 4 weeks