Status:
COMPLETED
Llama Antibody, Rotavirus Diarrhoea, Children
Lead Sponsor:
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborating Sponsors:
Unilever Nederland Holdings
Conditions:
Male Children
6-24 Months Old With Rotaviral Diarrhoea
Eligibility:
MALE
6-24 years
Phase:
PHASE2
Brief Summary
The investigators hypothesize that : oral administration of VHH batch 203027 will be * safe and tolerable for healthy Bangladeshi humans of all age groups (Part I) * effective in reducing severity o...
Detailed Description
Brief Summary Study investigating the efficacy of oral administration of VHH antibody fragment derived from antibodies as found in milk of llamas and camels via a prototype food product in reducing th...
Eligibility Criteria
Inclusion
- Sex: Male
- Age: 6-24 months
- History of watery diarrhoea of 48 hours or less
- At least 4 liquid stools during the previous 24 hours
- No V. cholerae in a dark-field test microscopy
- Presence of rotavirus in stool as determined by ELISA
- Written informed consent for participation by respective parents/guardians
Exclusion
- Systemic infection(s) requiring antibiotic treatment
- Severe malnutrition (W/H \<-3SD)
- History of bloody diarrhoea
- Patient unwilling to comply with study protocol
- Currently participating or have participated in another clinical trial during the last 3 weeks prior to this study.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT01259765
Start Date
January 1 2006
End Date
November 1 2009
Last Update
August 9 2011
Active Locations (1)
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1
Dhaka Hospital
Dhaka, Bangladesh, 1212