NCT05519254 Lactoferrin and Lysozyme Supplementation for Long-term Diarrhea Sequelae
| NCT ID | NCT05519254 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Washington |
| Condition | Diarrhea |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2023-03-10 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 600 participants in total. It began in 2023-03-10 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 facility nutritionists and ready to return home. Participation in the study will entail providing information on the child's health history, collection of stool samples, blood, and potentially urine. The caregiver will be provided sachets of the investigational product to take home and mix daily with their child's porridge or other complimentary food, and asked to return to the clinic 4 times in the subsequent 6 months, and also consent to having a community health worker visit their home every two weeks for a follow up visit. The risks to the participant and their caregiver are minimal. The information gained in this study will help us create new treatments and develop new strategies to treat sick children to prevent death and illness.
Eligibility 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
Contact & Investigator
Patricia B Pavlinac
PRINCIPAL INVESTIGATOR
University of Washington
Frequently Asked Questions
Who can join the NCT05519254 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, up to 24 Months, studying Diarrhea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05519254 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 600 participants.
Is NCT05519254 currently recruiting?
Yes, NCT05519254 is actively recruiting participants. Contact the research team at ruchit@uw.edu for enrollment information.
Where is the NCT05519254 trial being conducted?
This trial is being conducted at Homa Bay, Kenya, Isibania, Kenya, Kisii, Kenya, Rongo, Kenya.
Who is sponsoring the NCT05519254 clinical trial?
NCT05519254 is sponsored by University of Washington. The principal investigator is Patricia B Pavlinac at University of Washington. The trial plans to enroll 600 participants.