Maternal and child undernutrition and overweight in low-income and middle-income countries.
Robert E Black, Cesar G Victora, Susan P Walker...
https://pubmed.ncbi.nlm.nih.gov/23746772Actively Recruiting
Phase 3
Age: 6Months - 24Months
All Genders
Healthy Volunteers
ID05519254
Lactoferrin and Lysozyme Supplementation for Long-term Diarrhea Sequelae in Children with Malnutrition
Led by University of Washington · Updated on 2025-09-11
600
Participants Needed
4
Research Sites
21 weeks
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how nutritional supplements made from milk proteins, lactoferrin and lysozyme, may help children aged 6 to 24 months who were hospitalized for diarrhea and have malnutrition. These children are at high risk of repeated diarrhea and poor nutritional recovery despite receiving usual treatments like oral rehydration solutions. The study is a phase 3, double-blind, placebo-controlled randomized trial taking place at seven hospitals in Western Kenya, enrolling 600 participants. Participants will be randomly assigned to receive one of four treatments daily for 16 weeks: lactoferrin, lysozyme, a combination of both, or a placebo made of rice powder. Caregivers will mix the assigned supplement with porridge or other complementary foods. After treatment, children will be followed for a total of 24 weeks with clinic visits at weeks 4, 10, 16, and 24, along with bi-weekly home visits by community health workers. During the study, researchers will collect health history information and samples including stool, blood, and possibly urine. They will monitor diarrhea episodes, nutritional recovery, hospitalizations, growth measurements, and markers of intestinal health. Caregivers will report adherence and acceptability of the supplements. The study aims to assess whether these supplements reduce diarrhea recurrence and improve nutrition over six months, while also evaluating safety and cost-effectiveness.
CONDITIONS
Brief Title
Lactoferrin and Lysozyme Supplementation for Long-term Diarrhea Sequelae
Who Can Participate
Age: 6Months - 24Months
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Age between 6 and 24 months
- Hospitalized or treated as outpatient for diarrhea at a recruiting site
- Moderate or severe wasting with MUAC less than 12.5 cm at screening
- Plan to remain within the study area for at least 6 months
You will not qualify if you...
- Younger than 6 months or older than 24 months
- Caregiver does not consent to participation
- History of two or more blood transfusions in past 12 months
- Exclusively breastfeeding at enrollment
- Congenital defect or syndrome preventing age-appropriate feeding (e.g., cleft palate)
- Allergy to dairy products
- Child not ready to return home or discharged against medical advice
- Unwilling to participate in the dual sugar permeability sub-study if selected
- Enrolled in another study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 16 weeks
Participants receive a 16-week course of lactoferrin, lysozyme, a combination of the two, or placebo to reduce diarrhea incidence and improve nutritional recovery.
Clinic visits at weeks 4, 10, and 16 with bi-weekly home visits by community health workers
Follow-up
Duration - 8 weeks
Participants are monitored for an additional 8 weeks after treatment to observe long-term effects on diarrhea incidence and nutritional recovery.
Clinic visit at week 24 with bi-weekly home visits by community health workers
Trial Site Locations
Total: 4 locations
1
Homa Bay County Referral Hospital
Homa Bay, Kenya
Actively Recruiting
2
Isebania Sub-County Hospital
Isibania, Kenya
Actively Recruiting
3
Kisii Teaching and Referral Hospital
Kisii, Kenya
Actively Recruiting
4
Rongo Sub-County Hospital
Rongo, Kenya
Actively Recruiting
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Research Team
R
Ruchi Tiwari
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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Published Research Related To This Trial
Impact of Childhood Nutritional Status on Pathogen Prevalence and Severity of Acute Diarrhea.
Kirkby D Tickell, Patricia B Pavlinac, Grace C John-Stewart...
https://pubmed.ncbi.nlm.nih.gov/29140236Mortality after inpatient treatment for diarrhea in children: a cohort study.
Alison Talbert, Moses Ngari, Evasius Bauni...
https://pubmed.ncbi.nlm.nih.gov/30686268The effect of acute malnutrition on enteric pathogens, moderate-to-severe diarrhoea, and associated mortality in the Global Enteric Multicenter Study cohort: a post-hoc analysis.
Kirkby D Tickell, Rumana Sharmin, Emily L Deichsel...
https://pubmed.ncbi.nlm.nih.gov/31981554Determinants of linear growth faltering among children with moderate-to-severe diarrhea in the Global Enteric Multicenter Study.
Rebecca L Brander, Patricia B Pavlinac, Judd L Walson...
https://pubmed.ncbi.nlm.nih.gov/31767012Supplementation With Lactoferrin and Lysozyme Ameliorates Environmental Enteric Dysfunction: A Double-Blind, Randomized, Placebo-Controlled Trial.
William D Cheng, Karl J Wold, Lucy B Bollinger...
https://pubmed.ncbi.nlm.nih.gov/30829679Randomized double-blind controlled trial of bovine lactoferrin for prevention of diarrhea in children.
Theresa J Ochoa, Elsa Chea-Woo, Nelly Baiocchi...
https://pubmed.ncbi.nlm.nih.gov/22939927Efficacy of rice-based oral rehydration solution containing recombinant human lactoferrin and lysozyme in Peruvian children with acute diarrhea.
Nelly Zavaleta, Dante Figueroa, Juan Rivera...
https://pubmed.ncbi.nlm.nih.gov/17255841Lactoferrin and lysozyme to promote nutritional, clinical and enteric recovery: a protocol for a factorial, blinded, placebo-controlled randomised trial among children with diarrhoea and malnutrition (the Boresha Afya trial).
Ruchi Tiwari, Kirkby D Tickell, Emily Yoshioka...
https://pubmed.ncbi.nlm.nih.gov/39122384