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New treatment option for Diarrhea
Official title Lactoferrin and Lysozyme Supplementation for Long-term Diarrhea Sequelae
ClinicalTrials.gov ID: NCT05519254
What this study is testing
What is Lactoferrin + Lysozyme?
Lactoferrin + Lysozyme is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for diarrhea.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 24. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Homa Bay, Kenya
- Isibania, Kenya
- Kisii, Kenya
- Rongo, Kenya
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 months to 24 months. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Homa Bay, Kenya; Isibania, Kenya; Kisii, Kenya; Rongo, Kenya. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.