Nutritional supplements to prevent diarrhea in malnourished children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of milk-derived nutritional supplements, lactoferrin and lysozyme, in preventing recurrent diarrhea and improving nutritional recovery in children aged 6-24 months who have been hospitalized for diarrhea and malnutrition. The study will enroll 600 participants from seven hospitals in Western Kenya and will randomly assign them to receive either lactoferrin, lysozyme, a combination of both, or a placebo for 16 weeks. Participants will be monitored for 24 weeks with bi-weekly home visits and clinic check-ups to assess the impact of the supplements on diarrhea incidence and nutritional status.

Why it matters

Who can join: the full rules

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

Where it's running

• Homa Bay County Referral Hospital
  Homa Bay, Kenya Recruiting
• Isebania Sub-County Hospital
  Isibania, Kenya Recruiting
• Kisii Teaching and Referral Hospital
  Kisii, Kenya Recruiting
• Rongo Sub-County Hospital
  Rongo, Kenya Recruiting

Study contacts

• Principal investigator: Patricia B Pavlinac — University of Washington
• Study coordinator: Ruchi Tiwari
• Email: ruchit@uw.edu
• Phone: 2067904389

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.