Amebiasis
Conditions
Keywords
Amebiasis, Entamoeba histolytica
Brief summary
The purpose of this study is to determine the effect of nitazoxanide tablets in treating diarrhea caused by Entamoeba histolytica in adults and adolescents.
Interventions
DRUGNitazoxanide
Sponsors
Romark Laboratories L.C.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥12 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Resolution of clinical symptoms of amebiasis | — |
Secondary
| Measure | Time frame |
|---|---|
| Eradication of cyst or trophozoites of E. histolytica from post-treatment stool samples | — |
| Time from initiation of treatment to passage of last unformed stool | — |
Countries
Egypt
Outcome results
None listed