BridgeMD
New treatment option for Severe Acute Malnutrition
Official title Milk Fat Globule Membrane-Enhanced RUTF for Children With Severe Acute Malnutrition
ClinicalTrials.gov ID: NCT06869850
What this study is testing
What is Amoxicillin?
Amoxicillin is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for severe acute malnutrition.
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
- The goal of this clinical trial is to test the use of milk fat globule membrane (MFGM) in ready-to-use therapeutic food (RUTF) in children with severe acute malnutrition in Sierra Leone. The main questions it aims to answer are: Will the inclusion of MFGM in RUTF for 6-59-month-old Sierra Leonean children with severe acute malnutrition improve their neurodevelopment?
- Time commitment: about 12 weeks
- Which group you join is decided by chance.
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 59
You may be able to join if
- 6-59 months of age
- Reside within the catchment area of a participating clinic
- mid-upper arm circumference \< 11.5 cm and/or weight-for-length z-score \< -3 and/or presence of bilateral pedal pitting edema
- willingness to comply with all study procedures and availability for the duration of the study, including no plan to move from the catchment area of...
You likely can't join if
- Features of complicated SAM: inability to tolerate a 30 g test dose of RUTF, breathing difficulties, mental status changes, sepsis, diarrhea with...
- Participation in a separate therapeutic feeding program within the past month
- Known allergy to study food ingredient (peanut, milk, fish)
- Clinically evident developmental delay (most often determined based on research nursing assessment of physical appearance, movement, and informal...
- Presence of a chronic severe medical condition (other than tuberculosis and HIV), such as congenital heart disease
The study team makes the final eligibility decision.
Where it's taking place
- Bandajuma, Pujehun, Sierra Leone
- Bandasuma, Pujehun, Sierra Leone
- Bendu Malen, Pujehun, Sierra Leone
- Gbondapi, Pujehun, Sierra Leone
- Jendema, Pujehun, Sierra Leone
- Potoru, Pujehun, Sierra Leone
- Sahn Malen, Pujehun, Sierra Leone
- Taninahun, Pujehun, Sierra Leone
- Zimmi, Pujehun, Sierra Leone
- Pujehun, Sierra Leone
Compensation & support
Compensation likely.
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 study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 6 months to 59 months. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bandajuma, Pujehun, Sierra Leone; Bandasuma, Pujehun, Sierra Leone; Bendu Malen, Pujehun, Sierra Leone; Gbondapi, Pujehun, Sierra Leone; Jendema, Pujehun, Sierra Leone; Potoru, Pujehun, Sierra Leone and 4 more location(s). 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.