Official Title: “Multi-Center, Double-Blind, Placebo-Controlled Study of Nitazoxanide Suspension in the Treatment of Diarrhea Caused by Entamoeba Histolytica in Children”

The purpose of this study is to determine the effect of nitazoxanide suspension in treating diarrhea caused by Entamoeba histolytica in children.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Nitazoxanide

Primary Measures

• Resolution of clinical symptoms of amebiasis

Secondary Measures

• Eradication of cyst or trophozoites of E. histolytica from post-treatment stool samples
• Time from initiation of treatment to passage of last unformed stool

Inclusion Criteria:

• Age 1 to 11 years.
• Patients with diarrhea (≥3 bowel movements/day) with one or more enteric symptoms such as bloody stools, rectal bleeding or enlarged colon.
• Positive stool ELISA test for Entamoeba histolytica within 7 days prior to enrollment.

Exclusion Criteria:

• Patients with identified causes of diarrhea other than E. histolytica.
• Use within 2 weeks of enrollment of any drug or therapy with possible anti-protozoal activity.
• Females who are pregnant, suspected of being pregnant or breastfeeding.
• Serious systemic disorders incompatible with the study.
• History of hypersensitivity to nitazoxanide.
• Patients in whom the possibility of receiving placebo and not being able to receive immediately an effective treatment will be incompatible with the severity of the patient's illness.
• Patients with amebic liver abscess.
• Patients known to have or suspected of having AIDS.
• Patient with immune deficiencies.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 1 Year

Maximum Age for this Clinical Trial: 11 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Romark Laboratories L.C.

Overall Clinical Trial Officials and Contacts

Samir M Kabil, MD Principal Investigator Benha University Hospital  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00366730

Study ID Number: RM02-3014

ClinicalTrials.gov Identifier: NCT00366730

Health Authority: Egypt: Ministry of Health and Population