An interventional study of Albendazole and Placebo in Enteropathy, sponsored by Washington University School of Medicine. Completed at 1 site in Malawi. Open to participants aged 1 Year to 3 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-03-06.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Treatment
The purpose of this study is to investigate the therapeutic effectiveness of high-dose zinc therapy and de-worming albendazole as separate interventions in restoring normal gut absorptive and immunological function as measured by the dual sugar permeability test and additional biomarkers in 1-3 year old rural Malawian children at high risk for Environmental Enteropathy.
963 studies on the registry are indexed under Intestinal Diseases; 174 are open to participants now.
This study's enrollment of 225 is above the median of 70 across 552 interventional studies indexed under Intestinal Diseases.
Browse Intestinal Diseases studies →Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
High-dose zinc, equivalent 20 mg elemental zinc, to be given once per day for 14 days
Dietary Supplement: High-dose Zinc
Albendazole to be given once on the day of enrollment. Placebo will then be given for 13 days following.
Drug: Albendazole
Placebo will be given for 14 days
Drug: Placebo
Pill form, to be given once, 200 mg dosage for children 1-2 years of age, 400 mg dosage for children 2-3 years of age
Pill form, 400 mg dose to be given once per day for 14 days in Placebo arm and 13 days in Albendazole arm following one dose of Albendazole.
Pill form, equivalent to 20 mg elemental zinc, to be given once per day for 14 days
Changes in urine lactulose:mannitol (L:M) ratio following therapy course.
Time frame: 4 weeks, 7 weeks
Change in blood endoCAb
Time frame: 7 weeks
Change in fecal calprotectin mRNA
Time frame: 4 weeks, 7 weeks
This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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Washington University School of Medicine