Lactoferrin and Lysozyme Supplementation for Long-term Diarrhea Sequelae

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other, Dietary supplement, Combination product
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 2
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Kenya
Homa Bay County Referral Hospital
RECRUITING
Homa Bay
Isebania Sub-County Hospital
RECRUITING
Isibania
Kisii Teaching and Referral Hospital
RECRUITING
Kisii
Rongo Sub-County Hospital
RECRUITING
Rongo
Contact Information
Primary
Ruchi Tiwari
ruchit@uw.edu
2067904389
Time Frame
Start Date: 2023-03-10
Estimated Completion Date: 2026-12
Participants
Target number of participants: 600
Treatments
Experimental: Lactoferrin Arm
16-week course of lactoferrin
Experimental: Lysozyme Arm
16-week course of lysozyme
Experimental: Combination Arm (Lactoferrin + Lysozyme)
16-week course of lactoferrin and lysozyme
Placebo_comparator: Placebo Arm
16-week course of taste/appearance-matched placebo
Related Therapeutic Areas
Sponsors
Leads: University of Washington
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This content was sourced from clinicaltrials.gov

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