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Lactoferrin and Lysozyme Supplementation for Long-term Diarrhea Sequelae

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 11, 2025 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Secondary endpoints: 22 to 23v8 See this version in full on ClinicalTrials.gov ↗
  2. Re-verified, no change to tracked fieldsv7
  3. Enrollment target: 150 to 600v6
  4. Interventions: Lactoferrin (Dietary Supplement), Lactoferrin + Lysosyme (Combination Product), Lysosyme (Dietary Supplement), Placebo (Other) to Lactoferrin (Dietary Supplement), Lactoferrin + Lysozyme (Combination Product), Lysozyme (Dietary Supplement), Placebo (Other)v5
  5. Primary endpoints revised (2) Secondary endpoints: 25 to 22v4 Show 1 more changeShow less
    • Secondary endpoints: 25 to 22

    See this version in full on ClinicalTrials.gov ↗

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  1. Primary endpoints revised (2) Study sites: 1 to 4 · Secondary endpoints revised (25) · Study description expanded, about 3 wordsv3 Show 3 more changesShow less
    • Study sites: 1 to 4
    • Secondary endpoints revised (25)
    • Study description expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Not Yet Recruiting to Recruiting Primary endpoints revised (2) · Study sites: 0 to 1 · Start date changed from estimate of Jan 2023 to Mar 10, 2023 · 3 morev2 Show 6 more changesShow less
    • Primary endpoints revised (2)
    • Study sites: 0 to 1
    • Start date changed from estimate of Jan 2023 to Mar 10, 2023
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: 19 to 25
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05519254
Lead Sponsor University of Washington
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions Diarrhea, Wasting, Malnutrition, Child
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov