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โ† Trials
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Lactoferrin and Lysozyme Supplementation for Long-term Diarrhea Sequelae

RecruitingPhase 3Ages 6 Months - 24 MonthsAllUniversity of Washington
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In plain words

What the trial is, and whether it could suit you

Children in low- and middle-income countries who are hospitalized for diarrhea and also have malnutrition are at high risk for illness and death in the 6 months period following treatment for diarrhoea despite receiving current guideline recommended diarrhea management (such as oral rehydration solution, or "ORS"). This study will test whether nutritional supplements made from milk (lactoferrin or lysozyme) or a combination of the two (lactoferrin and lysozyme) will prevent children from having repeated diarrhea episodes and help improve their nutrition by improving their stomach health or preventing new disease during this 6-month period. The study is taking place at 7 hospitals in Western Kenya. Six hundred participants will be enrolled if they provide informed consent to participate, are aged 6-24 months, were hospitalized with diarrhea and malnutrition and have been managed by the fa

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age 6-24 months * Managed as an outpatient or inpatient for diarrhea at one of the recruiting sites * MUAC \<12.5 cm at the time of screening * Plan to stay within the study area for the next 6 months or greater Exclusion Criteria: * Age younger than 6 months or older than 24 months * Caregiver does not provide consent to study participation * History of 2 or more blood transfusions in the past 12 months * Exclusively breastfeeding at the time of enrollment * History of congenital defect or syndrome that prevents age-appropriate feeding (e.g. cleft palate) * History of allergy to dairy products * Child is not ready to return home (is not yet discharged), or discharged against medical advice * Unwilling to participate in the dual sugar permeability sub-study if selected * Enrollment in another study
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What it tests

  • Lactoferrin
  • Lysozyme
  • Lactoferrin + Lysozyme
  • Placebo
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Where

4 sites
Homa Bay County Referral Hospital
Homa Bay, Kenya
Isebania Sub-County Hospital
Isibania, Kenya
Kisii Teaching and Referral Hospital
Kisii, Kenya
Rongo Sub-County Hospital
Rongo, Kenya
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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