Impact of nutrition on pharmacokinetics and efficacy of praziquantel
Impact of pre-treatment food intake on praziquantel efficacy, side-effects and pharmacokinetics in Schistosoma-infected school-aged children
All children will be screened for Schistosoma infection at baseline using the study diagnostic procedures. Only children with a confirmed Schistosoma infection will be enrolled in the randomized controlled trial. All enrolled participants will receive a single oral dose of praziquantel (40 mg/kg body weight). Prior to treatment, all participants will be assessed for their status of the following micronutrients: haemoglobin, serum ferritin, sTfR, 25-hydroxyvitamin D, retinol binding protein, serum albumin, CRP, and AGP. Furthermore, all participants will be randomly allocated in a 1:1:1 ratio to one of three study arms: (i) no food provided by the study prior to treatment, with participants encouraged to consume their usual meal at home; (ii) a high-carbohydrate meal provided prior to treatment; or (iii) a high-fat meal provided prior to treatment. The meals will be administered before praziquantel treatment according to the study protocol. Randomization will be performed after completion of baseline assessments using a computer-generated randomization sequence implemented in R. Allocation will be balanced with respect to sex, age, and baseline infection intensity. Following meal consumption, all participants will receive praziquantel under direct observation. Subsequently, treatment efficacy, pharmacokinetic parameters and treatment-related adverse events will be assessed.
1. Aged between and including 6 and 15 years 2. A parent/legal guardian provided written informed consent 3. The child provided a signed assent form 4. Agree to comply with study procedures, including providing two stool samples and a urine sample at baseline and during the follow-up survey between 21- and 35-days post-treatment, and venous blood collection and blood micro sampling for dried blood spots (DBS)
1. Presence or signs of major systemic diseases, i.e., temperature ≥ 38°C, severe anaemia (below 80 g/L, Hb according to WHO , based on baseline clinical examination 2. History of severe acute or chronic illness 3. Recent use of an anthelmintic drug (within the last 4 weeks) 4. Participation in other intervention studies during the same study period 5. Pregnancy and/or a planned pregnancy within the next 3 months 6. A known allergy to investigational products (i.e., praziquantel or study foods) 7. Taking a medication known to be contraindicated for or interacting with praziquantel