NCT00607074

Impact of Anti-Giardia and Antihelmintic Treatment on Infant Growth in Bangladesh

Effects of Anti-Giardia and Antihelmintic Treatment on Infant Nutritional and Biochemical Status and Intestinal Permeability in Rural Bangladesh

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 410 (actual)
• Sponsor: University of Cambridge · Academic / Other
• Sex: All
• Age: 3 Months – 15 Months
• Healthy volunteers: Accepted

Summary

This longitudinal study aimed to assess whether regular anti-Giardia and antihelmintic treatment improved growth and small intestinal mucosal function of rural Bangladeshi infants.

Detailed description

A randomised double-blind controlled intervention of 36 weeks duration was conducted in a rural community located 40kms north-west of Dhaka, the capital of Bangladesh. Infants aged between 3 and 11 months were randomly assigned to either receiving anti-Giardia and antihelmintic treatment, or anti-Giardia treatment only, or a control group receiving placebos. Weight and supine length were recorded every 4 weeks. Every 12 weeks intestinal permeability (L/M ratio), haemoglobin, plasma albumin, alpha-1-acid glycoprotein, immunoglobulin G and Giardia intestinalis specific IgM titre (GSIgM) and eggs of the three common geohelminths and Giardia intestinalis cysts were determined.

Conditions

• Giardiasis

Interventions

Type	Name	Description
DRUG	Anti-Giardia and antihelmintic treatment (secnidazole or albendazole)	Every 4 weeks: Secnidazole (70mg/ml suspension, 0.5ml per kg of body weight) or a placebo was administered Every 12 weeks: Albendazole (syrup, 200mg)
DRUG	Anti-Giardia treatment only (secnidazole or albendazole)	Every 4 weeks: Secnidazole (70mg/ml suspension, 0.5ml per kg of body weight) Every 12 weeks: placebo of Albendazole
DRUG	Control group (placebo)	Every 4 weeks: Secnidazole placebo Every 12 weeks: Albendazole placebo

Timeline

• Start date: 2003-06-01
• Primary completion: 2004-04-01
• Completion: 2006-12-01
• First posted: 2008-02-05
• Last updated: 2008-02-05

Locations

1 site across 1 country: Bangladesh