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Llama Antibody, Rotavirus Diarrhoea, Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01259765
Recruitment Status : Completed
First Posted : December 14, 2010
Last Update Posted : August 9, 2011
Information provided by:

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

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

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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)
Study Start Date : January 2006
Primary Completion Date : September 2008
Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :
  1. Diarrhoea severity (indicated by reduced stool volume) [ Time Frame: 4-5 days ]

    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 :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 24 Months   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01259765

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

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
First Posted: December 14, 2010    Key Record Dates
Last Update Posted: August 9, 2011
Last Verified: February 2006

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

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Immunologic Factors
Physiological Effects of Drugs