A Phase 3 interventional study of Lactoferrin and Lysozyme in Diarrhea, Wasting and Malnutrition, Child, sponsored by University of Washington. Recruiting at 4 sites in Kenya. Open to participants aged 6 Months to 24 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-11.
Sponsored by University of Washington · Phase 3, Interventional, and Treatment
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.
Current diarrhea management strategies in low- and middle-income countries (oral rehydration solution, ReSoMal and zinc) focus primarily on the management of dehydration and micronutrient replacement and appear to have negligible impact in preventing future diarrheal episodes or improving nutritional outcomes. Lactoferrin and lysozyme are milk-derived nutritional supplements that may reduce the risk of diarrheal episodes and accelerate nutritional recovery by treating or preventing underlying enteric infections and/or improving enteric function. Children with moderate or severe wasting are at particularly high-risk of death, diarrhea recurrence, and nutritional deterioration following a diarrheal episode. This factorial, double-blind, placebo-controlled, randomized trial aims to determine the efficacy of lactoferrin and lysozyme supplementation in decreasing diarrhea incidence and improving nutritional recovery in children convalescing from diarrhea and wasting. We will explore whether these interventions improve outcomes by reducing enteric pathogens, improving enteric function and/or increasing hemoglobin concentrations in these children. This study aims to enroll 600 Kenyan children aged 6-24 months from facilities in Western Kenya. Enrolled children will be randomized to 16-weeks of lactoferrin, lysozyme, a combination of the two, or placebo and be followed up for 24 weeks total, with bi-weekly home visits by community health workers and clinic visits at 4, 10, 16, and 24 weeks. Results of this study will inform management strategies for children with moderate/severe wasting at high risk for mortality, morbidity, and nutritional deterioration following diarrhea.
Aim 1: To determine whether a 16-week course of lactoferrin, lysozyme or a combination of both shortens time to WHO-defined recovery from wasting (MUAC ≥12.5cm) and reduces the incidence of moderate-to-severe diarrhea during the subsequent 6-months following presentation to a health facility with diarrhea among children with moderate/severe childhood wasting (MUAC \<12.5 cm at the time of screening).
Hypothesis: Children randomized to lactoferrin, lysozyme, or the combination of both will experience a lower incidence of moderate-to-severe diarrhea and an earlier recovery from wasting (increased MUAC) over the subsequent 6-months than placebo-treated children. Combination therapy will provide synergistic benefit in reducing diarrhea and improving nutritional recovery.
Aim 2: To explore whether a 16-week course of lactoferrin, lysozyme or combination therapy improves secondary clinical, nutritional, enteric pathogen, and enteric function outcomes.
Hypothesis: Children randomized to lactoferrin, lysozyme, or the combination will experience fewer hospitalizations and deaths, improved linear growth, a reduced prevalence of specific enteric bacteria associated with linear growth failure (Campylobacter, LT-ETEC, EAEC, typical EPEC and/or Shigella), improved markers of enteric dysfunction (myeloperoxidase, alpha antitrypsin, neopterin, and the lactulose:rhamnose ratio) and improved hemoglobin, as compared to placebo-treated children.
Aim 3: To evaluate acceptability, adherence and cost-effectiveness of lactoferrin and/or lysozyme in Kenya.
Hypothesis: Both therapies will be highly acceptable to caregivers and health workers. Adherence to the therapies will be high among participants (≥ 95%). Lactoferrin and lysozyme, alone and in combination, will be more cost-effective interventions for reducing moderate-to-severe diarrhea in the short-term as compared to the standard-of-care.
877 studies on the registry are indexed under Diarrhea; 76 are open to participants now.
This study's planned enrollment of 600 is above the median of 137 across 738 interventional studies indexed under Diarrhea.
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Exclusion Criteria:
16-week course of lactoferrin
Dietary Supplement: Lactoferrin
16-week course of lysozyme
Dietary Supplement: Lysozyme
16-week course of lactoferrin and lysozyme
Combination Product: Lactoferrin + Lysozyme
16-week course of taste/appearance-matched placebo
Other: Placebo
Caregivers of children will be instructed to provide 1.5g of lactoferrin with 40g of unmodified rice powder daily mixed with 125 mL of porridge or other complimentary food.
Caregivers of children will be instructed to provide 41.5g of Lysosure daily mixed with 125 mL of porridge or other complimentary food.
Drug pages: Lactoferrin · Muramidase
Caregivers of children will be instructed to provide 40g of Lysosure with 1.5 grams of lactoferrin daily mixed with 125 mL of porridge or other complimentary food.
Caregivers of children will be instructed to provide 41.5 grams of unmodified rice powder daily mixed with 125 mL of porridge or other complimentary food.
Incidence of moderate-to-severe diarrhea
Defined as total number of new diarrhea episodes (\> 48 hours after a diarrhea-free period) deemed moderate-to-severe, divided by the child-time at risk during the 6-month follow-up period. Moderate-to-severe diarrhea will be defined as ≥ 3 using the CODA (Community DiarrhoeA) diarrhea severity score or dysentery (evidence or reported visible blood in stool).
Time frame: 6 months
Time to nutritional recovery
Defined as the number of days since enrollment to the date of the second of two consecutive MUAC measurements ≥ 12.5 cm.
Time frame: 6 months
Incidence of diarrhea (any severity)
Diarrhea (any severity) will be defined as diarrhea (3 or more abnormally loose or watery stool) during follow-up, irrespective of severity, ascertained through follow-up visit questionnaires and a diarrhea diary. Episodes will be defined as per the primary outcome.
Time frame: 6 months
Incidence of severe diarrhea
Severe diarrhea defined by the CODA diarrhea severity score of 7 or more or dysentery. Episodes will be defined as per the primary outcome.
Time frame: 6 months
Incidence of dysentery
Dysentery will be defined as evidence or reported visible blood in stool. Episodes will be defined as per the primary outcome.
Time frame: 6 months
Incidence of medically-attended diarrhea
Medically-attended diarrhea will be defined as diarrhea that led to an outpatient or inpatient visit at a health facility or hospital that is typically attended by a nurse, clinical officer, and/or physician. Episodes will be defined as per the primary outcome.
Time frame: 6 months
Cumulative duration of diarrhea
Defined as cumulative days of diarrhea ascertained from follow-up visit questionnaires and a diarrhea diary, irrespective of episodes
Time frame: 6 months
Proportion of children who recovered from wasting based on two consecutive MUAC measurements ≥12.5 at any point during the follow-up period.
Time frame: 6 months
Incidence of hospitalization
Defined as any inpatient admission that results in an overnight stay (irrespective of diagnosis) in a health-facility and time to hospitalization or death analyzed as a combined outcome
Time frame: 6 months
Composite outcome of time to hospitalization and death
Hospitalization will be defined as any inpatient admission that results in an overnight stay (irrespective of diagnosis) in a health-facility
Time frame: 6 months
Hemoglobin concentration
Will be determined at week 16
Time frame: Measured at week 16
Change in length for age z-score (linear growth)
Growth that includes length and weight measurements at each time point will be used to create age-standardized z-scores, calculated using WHO-established reference standards and the WHO ANTHRO software. Linear growth will be defined as change (Δ) in LAZ.
Time frame: 6 months
Change in weight for length z-score
Growth that includes length and weight measurements at each time point will be used to create age-standardized z-scores, calculated using WHO-established reference standards and the WHO ANTHRO software. Ponderal growth will be defined as change (Δ) in weight for length z-score (WLZ) and Δ MUAC.
Time frame: 6 months
Change in mid-upper arm circumference (cm)
Growth that includes length and weight measurements at each time point will be used to create age-standardized z-scores, calculated using WHO-established reference standards and the WHO ANTHRO software. Ponderal growth will be defined as change (Δ) in weight for length z-score (WLZ) and Δ MUAC.
Time frame: 6 months
Concentration of fecal alpha antitrypsin (mg/g)
Fecal biomarker of enteric function
Time frame: Measured at baseline, week 4, 16, and 24
Concentration of fecal myeloperoxidase (ng/mL)
Fecal biomarker of enteric function
Time frame: Measured at baseline, week 4, 16, and 24
Concentration of fecal calprotectin (mcg/g)
Fecal biomarker of enteric function
Time frame: Measured at baseline, week 4, 16, and 24
Lactulose:rhamnose ratio
Lactulose:rhamnose ratio is a functional assessment of enteric integrity. Ratio will be measured in subset of 50 children per arm (200 children total).
Time frame: Measured at week 4, 10, 16, and 24 for a subset of 200 participants (50 per arm)
Proportion of participants with enteric infections
Determined by qPCR at or below the minimum limit of detection (cycle thresholds \[CT\] \<35)
Time frame: Measured at week 4 for all participants and at week 16 and 24 for a subset of 200 participants (50 per arm)
Proportion of caregivers reporting that administration of lactoferrin and/or lysozyme was desirable or satisfactory via 5-point Likert scale responses in surveys and focus group discussions (FGDs)
Acceptability measure
Time frame: Week 4, 10, 16 (surveys) and 6 months (FGDs)
Proportion of caregivers reporting perceived trust, safety, and comfort in administering lactoferrin and/or lysozyme via 5-point Likert scale responses in surveys and focus group discussions (FGDs)
Acceptability measure
Time frame: Week 16 (surveys) and 6 months (FGDs)
Proportion of caregivers self-reporting their child consumed some or all of the investigational product ≥95% of the time using daily pictorial logs
Adherence measure
Time frame: 16 weeks
Proportion of children adherent to the recommended dosing based on objectively measured container consumption (± 10% consumption of prescribed IP in all weeks)
Adherence measure
Time frame: 16 weeks
Incremental costs of diarrhea
Incremental costs of diarrhea will be measured in each arm and compared to the placebo arm
Time frame: 6 months
Cost-per-episode of diarrhea averted
Cost-per-episode of diarrhea averted will be measured in each arm and compared to the placebo arm
Time frame: 6 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — The de-identified analytic dataset and analytic R code will be made publicly available.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: After publication.
Access criteria: Publicly available
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Studies of the drugs tested here: Lactoferrin · Muramidase