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Llama Antibody, Rotavirus Diarrhoea, Children

NCT01259765 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2011-08-09

No results posted yet for this study

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.

Conditions

  • Male Children
  • 6-24 Months Old With Rotaviral Diarrhoea
  • Non-cholera Patients

Interventions

DRUG

VHH batch 203027

The active product is 165 mg of VHH batch 203027 and 835 mg maltodextrin with 0.5% (w/w) caramel colour in 10 mL ORS. The osmolality (concentration of the osmotically active substances in the solution such as sugar molecules, salts etc. ) of this solution will be around 60 mOsmol/kg. The mixture of the 165 mg of VHH batch 203027 and 835 mg maltodextrin (0.5% (w/w) caramel colour will be provided per sachet.

DRUG

Placebo product

The Placebo treatment consisted of 1000 mg of maltodextrine with 5% (w/w) caramel colour in 10 mL ORS.

Sponsors & Collaborators

  • Unilever Nederland Holdings

    collaborator UNKNOWN

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    lead OTHER

Principal Investigators

  • Shafiqul A Sarker, MD, Ph. D. · International Centre for Diarrhoeal Disease Research, Bangladesh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
24 Months
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2008-09-30
Completion
2009-11-30

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01259765 on ClinicalTrials.gov