Clinical Trial: Schistosoma Mansoni Morbidity in Children Aged 1-5 Years

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Intestinal Schistosomiasis in Children Aged 1-5 Years,Morbidity Assessment and the Effect of Praziquantel on Morbidity; Along Lake Victoria Shorelines.

Brief Summary: This study is about intestinal schistosomiasis, commonly known as bilharzia, in children aged 1-5 years along Lake Victoria shoreline.The children will be screened for S. mansoni and the effects of the disease will be assessed.Children found positive with S. mansoni will be treated with praziquantel and followed up for a year.

Detailed Summary: The study has three phases: in the first phase (Phase I) a baseline pretreatment schistosomiasis morbidity assessment of children aged 1-5 years will take place. The Kato-Katz technique will be used to detect and enumerate S. mansoni eggs in faecal samples from each participating child. Communities with the highest S. mansoni prevalence and intensity will be chosen and included in the study. In the second phase (Phase II) the S. mansoni positive children will be divided randomly into two intervention groups, single and double dose praziquantel treatment arms. Abdominal ultrasound will be combined with clinical examination to accurately identify hepatosplenomegaly. The sizes of both the liver and spleen will be examined. Anthropometric measurements and Hb for each child will also be recorded. In the last phase (Phase III), the effect of praziquantel on S. mansoni morbidity will be evaluated in all the treated children aged 1-5 years.
Sponsor: Makerere University

Current Primary Outcome: Presence/absence of organomegaly at Day 0 and 8 months follow-up visits [ Time Frame: 2 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Cure rate at 30 days after treatment [ Time Frame: 2 years ]

Original Secondary Outcome: Same as current

Information By: Makerere University

Dates:
Date Received: May 30, 2013
Date Started: December 2012
Date Completion:
Last Updated: September 16, 2014
Last Verified: September 2014