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Probiotics for infectious diarrhea in children in south India

Probiotics for infectious diarrhea in children in south India

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2010/091/000339
Enrollment
160
Registered
2010-05-03
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Infectious Gastroenteritis

Interventions

Intervention1: Lactobacillus GG: 10 billion organisms given mixed in milk as food supplement once daily for four weeks Control Intervention1: Inulin:

Sponsors

Christian Medical College Vellore
Lead Sponsor

Eligibility

Inclusion criteria

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

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 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.

Design outcomes

Primary

MeasureTime frame
IgG to rotavirus VP6 or cryptosporidial g15 at 4 weeksTimepoint: 4 weeks

Secondary

MeasureTime frame
Lactulose:mannitol test at 4 weeksTimepoint: 4 weeks

Countries

India

Contacts

Public ContactGagandeep Kang
gkang@cmcvellore.ac.in0416-228-2052

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 8, 2026