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Completed

NCT Number: NCT00607074

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

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Key information

Conditions

Giardiasis Digestive System Diseases Gastrointestinal Diseases Infections Intestinal Diseases Intestinal Diseases, Parasitic Parasitic Diseases Protozoan Infections

Age range

3 month–15 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Institute of Preventive and Social Medicine

Mohakhali, Dhaka Division, 1212, Bangladesh

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • infants living in the study area

Treatment and study plan

Anti-Giardia and antihelmintic treatment (secnidazole or albendazole)

Drug

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)

Anti-Giardia treatment only (secnidazole or albendazole)

Drug

Every 4 weeks: Secnidazole (70mg/ml suspension, 0.5ml per kg of body weight) Every 12 weeks: placebo of Albendazole

Control group (placebo)

Drug

Every 4 weeks: Secnidazole placebo Every 12 weeks: Albendazole placebo

Primary outcomes

  1. nutritional status

    Time frame: 9 months

Secondary outcomes

  1. intestinal permeability

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

University of Cambridge

Other

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2004
Study completion
2006
First posted
Feb 5, 2008
Registry last updated
Feb 5, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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