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

Sponsored by:	University of Cambridge
Information provided by:	University of Cambridge
ClinicalTrials.gov Identifier:	NCT00607074

Purpose

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

Condition	Intervention
Giardiasis	Drug: Anti-Giardia and antihelmintic treatment (secnidazole or albendazole) Drug: Anti-Giardia treatment only (secnidazole or albendazole) Drug: Control group (placebo)

MedlinePlus related topics: Giardia Infections

Drug Information available for: Albendazole Secnidazole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Effects of Anti-Giardia and Antihelmintic Treatment on Infant Nutritional and Biochemical Status and Intestinal Permeability in Rural Bangladesh

Further study details as provided by University of Cambridge:

Primary Outcome Measures:

nutritional status [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

intestinal permeability [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Enrollment:	410
Study Start Date:	June 2003
Study Completion Date:	December 2006
Primary Completion Date:	April 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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

Assigned Interventions

1: Experimental

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

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.

Eligibility

Ages Eligible for Study:	3 Months to 15 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria: - infants living in the study area

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00607074

Locations

Bangladesh, Dhaka
National Institute of Preventive and Social Medicine
Mohakhali, Dhaka, Bangladesh, 1212

Sponsors and Collaborators

University of Cambridge

Investigators

Study Chair:

Nicholas C Mascie-Taylor, ScD

Department of Biological Anthropology, University of Cambridge

More Information

No publications provided by University of Cambridge

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Goto R, Mascie-Taylor CG, Lunn PG. Impact of anti-Giardia and anthelminthic treatment on infant growth and intestinal permeability in rural Bangladesh: a randomised double-blind controlled study. Trans R Soc Trop Med Hyg. 2009 May;103(5):520-9. Epub 2008 Sep 11.

Responsible Party:	Department of Biological Anthropology, University of Cambridge ( Dr Rie Goto )
Study ID Numbers:	BMRC/ERC/2001-2004/2281, BMRC/ERC/2001-2004/2281
Study First Received:	January 22, 2008
Last Updated:	February 4, 2008
ClinicalTrials.gov Identifier:	NCT00607074 History of Changes
Health Authority:	Bangladesh: Ethical Review Committee

Study placed in the following topic categories:

Albendazole
Protozoan Infections
Digestive System Diseases
Gastrointestinal Diseases
Secnidazole
Tubulin Modulators

Anthelmintics
Parasitic Diseases
Antimitotic Agents
Intestinal Diseases, Parasitic
Giardiasis
Intestinal Diseases

Additional relevant MeSH terms:

Anti-Infective Agents
Protozoan Infections
Antiprotozoal Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiplatyhelmintic Agents
Gastrointestinal Diseases
Mitosis Modulators
Mastigophora Infections
Anthelmintics
Antimitotic Agents
Giardiasis

Intestinal Diseases
Pharmacologic Actions
Anticestodal Agents
Albendazole
Antiparasitic Agents
Digestive System Diseases
Therapeutic Uses
Secnidazole
Tubulin Modulators
Parasitic Diseases
Sarcomastigophora Infections
Intestinal Diseases, Parasitic

ClinicalTrials.gov processed this record on May 07, 2009