The goal of this clinical trial is to learn whether a modified food supplement is acceptable and well tolerated by children aged 12 to 24 months with mild-to-moderate stunting in rural Guatemala. The study will also explore whether the food is associated with short-term changes in stool markers related to gut inflammation and microbial activity.
The main questions are:
* Will children accept and regularly eat the modified food supplement? * What stomach or bowel symptoms, if any, occur while children eat the supplement? * Do stool markers related to gut health change over the short study period?
Researchers will compare the modified food supplement with Nutri Listo, a small-quantity lipid-based nutrient supplement already used in Guatemala. Children will be assigned by chance to one of the two groups.
Participants will:
* Complete a brief taste and acceptability test * Eat one 30-gram sachet of the assigned food each day for 21 days * Have their caregiver receive brief phone or WhatsApp check-ins during the study * Provide a stool sample near the beginning and end of the study
This is a small pilot study. It is designed to assess feasibility, acceptability, tolerability, and early biological signals rather than to determine whether the modified food improves growth or other clinical outcomes.
Children aged 12 to 24 months at enrollment
Mild-to-moderate stunting, defined as height-for-age Z-score (HAZ) less than -1 and greater than -3
Primary caregiver willing and able to provide informed consent
Caregiver has access to a phone or WhatsApp, or has a trusted proxy such as a family member or neighbor who can assist with phone calls or WhatsApp communication
Moderate or severe acute malnutrition, defined as weight-for-height Z-score (WHZ) less than -2
Antibiotic use within the preceding 14 days
Known food allergy or intolerance to study ingredients, including peanut, dairy, or egg
History of persistent diarrhea, defined as watery stools lasting more than 7 consecutive days within the past month
Parallel
Modified Therapeutic Food Formulation
Dietary supplementA nutrient-dense, food-based supplement packaged in single-use 30-gram sachets. The formulation includes green banana flour, chickpea flour, roasted peanut paste, high-oleic oil, whey protein concentrate, micronutrients, and other food ingredients. Participants receive 30 grams daily for 21 days.
Nutri Listo SQ-LNS
Dietary supplementA commercially available small-quantity lipid-based nutrient supplement used in Guatemala for young children. For this study, Nutri Listo is provided in 30-gram sachets with the daily micronutrient amount adjusted for the study. Participants receive 30 grams daily for 21 days.
Acceptability and palatability of the study product
Acceptability and palatability will be assessed using structured study questionnaires. During the initial taste test, staff will record the amount of modified therapeutic food consumed, observed feeding behavior, and whether the caregiver believes the child would eat the product every day. At endline, caregivers will rate overall acceptance of the assigned study product on a 4-point scale: refused most of the time, accepted with difficulty, accepted well, or liked it very much.
Adherence to daily study product consumption
Adherence will be assessed during scheduled WhatsApp or telephone monitoring contacts using caregiver reports of whether the child consumed all, some, or none of the assigned product. At endline, staff will count remaining sachets and collect used sachets or wrappers to estimate product consumption during the 21-day home-feeding period.
Frequency and severity of gastrointestinal symptoms
During scheduled monitoring contacts, caregivers will report gastrointestinal symptoms occurring since the previous contact, including stomach pain, diarrhea or loose stools, vomiting, and bloating or gas. Symptom severity will be recorded as none, mild, or severe, and the specific symptom type will be documented when symptoms are reported.
Change in fecal calprotectin concentration
Fecal calprotectin will be measured using standard clinical assays in baseline and endline stool samples as a marker of intestinal inflammation. The outcome is the change in fecal calprotectin concentration from baseline to endline. Exploratory analyses will also compare the baseline-to-endline change between the modified therapeutic food and Nutri Listo arms.
Change in fecal short-chain fatty acid concentrations
Fecal short-chain fatty acids, including acetate, propionate, and butyrate, will be measured using established analytical methods in baseline and endline stool samples. The outcome is the change in short-chain fatty acid concentrations from baseline to endline. Exploratory analyses will also compare changes between the modified therapeutic food and Nutri Listo arms.
Directional change in gut microbiome composition
Gut microbiome composition will be assessed using 16S ribosomal RNA gene sequencing of baseline and endline stool samples. Analyses will characterize overall bacterial community structure and the relative abundance of major bacterial taxa and assess directional changes from baseline to endline. Exploratory analyses will also compare changes between study arms.
Fecal pH
Fecal pH will be assessed in stool samples collected at baseline and endline.
Click on the lead sponsor to view all of their trials.
Wuqu' Kawoq, Maya Health Alliance
Lead sponsor
Cooperación Listo Maní+, S.A.
Collaborator
Arizona State University
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
