Official Title: “Effects of Anti-Giardia and Antihelmintic Treatment on Infant Nutritional and Biochemical Status and Intestinal Permeability in Rural Bangladesh”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: April 2004

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.

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1

Primary Measures

• nutritional status
  • Time Frame: 9 months
    Safety Issue?: No

Secondary Measures

• intestinal permeability
  • Time Frame: 9 months
    Safety Issue?: No

• Inclusion Criteria: - infants living in the study area

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 3 Months

Maximum Age for this Clinical Trial: 15 Months

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: University of Cambridge

Overall Clinical Trial Officials and Contacts

Nicholas C Mascie-Taylor, ScD Study Chair Department of Biological Anthropology, University of Cambridge  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00607074

Study ID Number: BMRC/ERC/2001-2004/2281

ClinicalTrials.gov Identifier: NCT00607074

Health Authority: Bangladesh: Ethical Review Committee