Nutritional supplements to prevent diarrhea in malnourished children
Lactoferrin and Lysozyme Supplementation for Long-term Diarrhea Sequelae
This study is testing if milk-based nutritional supplements can help prevent diarrhea and improve recovery in malnourished children aged 6-24 months who have been hospitalized.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 6 Months to 24 Months |
| Sex | All |
| Sponsor | University of Washington Academic / other |
| Locations | 4 sites (Homa Bay and 3 other locations) |
| Trial ID | NCT05519254 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 6-24 months who have been hospitalized for diarrhea and malnutrition.
Not a fit: Patients who are younger than 6 months or older than 24 months, or those with specific medical conditions or contraindications, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of diarrhea and improve nutritional outcomes in malnourished children recovering from diarrhea.
How similar studies have performed: While the approach of using lactoferrin and lysozyme is promising, it is relatively novel and has not been extensively tested in this specific context.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Homa Bay and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.