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Llama Antibody, Rotavirus Diarrhoea, Children

This study has been completed.
Sponsor:
Collaborator:
Unilever Nederland Holdings
Information provided by:
International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier:
NCT01259765
First received: December 13, 2010
Last updated: August 8, 2011
Last verified: February 2006
  Purpose

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.

Condition Intervention Phase
Male Children
6-24 Months Old With Rotaviral Diarrhoea
Non-cholera Patients
Drug: VHH batch 203027
Drug: Placebo product
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Safety and Tolerability of a Novel Llama-derived Anti-rotavirus VHH Fragment in Human Volunteers (Part-I), and Its Effect on Severity and Duration of Rotavirus Diarrhoea in Children (Part II). (This Registration Only Covers Part II)

Resource links provided by NLM:


Further study details as provided by International Centre for Diarrhoeal Disease Research, Bangladesh:

Primary Outcome Measures:
  • Diarrhoea severity (indicated by reduced stool volume) [ Time Frame: 4-5 days ] [ Designated as safety issue: No ]

    The primary outcome measures of this study are to evaluate the efficacy of orally administered VHH batch 203027 by its ability to reduce:

    (i) diarrhoea severity (indicated by reduced stool volume) (ii) diarrhoea duration, and (iii) duration of faecal excretion of rotavirus



Secondary Outcome Measures:
  • Secondary aim: The secondary aim is to compare the influence of the passive immunisation with VHH on serum concentrations of anti-rotavirus antibody on day 4 and 21. [ Time Frame: 4-5 days ] [ Designated as safety issue: No ]

Enrollment: 176
Study Start Date: January 2006
Study Completion Date: November 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: VHH
The active substance is "VHH batch 203027".
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.
Placebo Comparator: Placebo
Placebo product
Drug: Placebo product
The Placebo treatment consisted of 1000 mg of maltodextrine with 5% (w/w) caramel colour in 10 mL ORS.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Months to 24 Months
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01259765

Locations
Bangladesh
Dhaka Hospital
Dhaka, Bangladesh, 1212
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Unilever Nederland Holdings
Investigators
Principal Investigator: Shafiqul A Sarker, MD, Ph. D. International Centre for Diarrhoeal Disease Research, Bangladesh
  More Information

No publications provided by International Centre for Diarrhoeal Disease Research, Bangladesh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr.Shafiqul Alam Sarker, International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT01259765     History of Changes
Other Study ID Numbers: 2004-009
Study First Received: December 13, 2010
Last Updated: August 8, 2011
Health Authority: Bangladesh: Ethical Review Committee

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
llama antibody
rotavirus diarrhoea
children

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on November 25, 2014