Llama Antibody, Rotavirus Diarrhoea, Children

NCT01259765 | Completed Phase 2 DMC

• 1 other identifier: 2004-009
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

llama antibody; rotavirus diarrhoea; children

Outcome Measures

Primary Outcomes (1)

• Diarrhoea severity (indicated by reduced stool volume)

  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

  4-5 days

Secondary Outcomes (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.

  4-5 days

Study Arms (2)

VHH

ACTIVE COMPARATOR

The active substance is "VHH batch 203027".

Drug: VHH batch 203027

Placebo

PLACEBO COMPARATOR

Placebo product

Drug: Placebo product

Interventions

VHH batch 203027 DRUG

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.

VHH

Placebo product DRUG

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

Placebo

Eligibility Criteria

• Age: 6 Months - 24 Months
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• Unilever Nederland Holdings: collaborator

Study Sites (1)

Dhaka Hospital

Dhaka, 1212, Bangladesh

Location

Related Publications (1)

• Sarker SA, Jakel M, Sultana S, Alam NH, Bardhan PK, Chisti MJ, Salam MA, Theis W, Hammarstrom L, Frenken LG. Anti-rotavirus protein reduces stool output in infants with diarrhea: a randomized placebo-controlled trial. Gastroenterology. 2013 Oct;145(4):740-748.e8. doi: 10.1053/j.gastro.2013.06.053. Epub 2013 Jul 2.

  PMID: 23831050 DERIVED

Study Officials

• Shafiqul A Sarker, MD, Ph. D.

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 13, 2010
• First Posted: December 14, 2010
• Study Start: January 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: November 1, 2009
• Last Updated: August 9, 2011

Record last verified: 2006-02

Locations

BA (1)