Llama Antibody, Rotavirus Diarrhoea, Children

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: Male

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 of diarrhoea in children with proven rotavirus infection (Part II). This entry only covers Part II.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
• Collaborator: Unilever Nederland Holdings
• Treatments: Antibodies

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.