Chronic Malnutrition, Stunting of Growth
Conditions
Keywords
Childhood stunting, Therapeutic food, Small-quantity lipid-based nutrient supplement, Gut microbiome, Environmental enteric dysfunction, Guatemala
Brief summary
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.
Detailed description
This randomized, open-label pilot study will compare a modified food supplement with Nutri Listo, a small-quantity lipid-based nutrient supplement currently used in Guatemala. Approximately 36 children aged 12 to 24 months with mild-to-moderate stunting will be enrolled and assigned to one of two study groups. The modified formulation combines commonly consumed food ingredients and nutrients, including peanut, green banana, chickpea, whey protein, vegetable oil, vitamins, and minerals. The comparison group will receive Nutri Listo. Both groups will receive one 30-gram sachet per day for 21 days. The study is primarily designed to evaluate whether the modified formulation can be feasibly delivered and is acceptable and well tolerated under home-based conditions. Caregivers will be contacted regularly during the intervention to assess product consumption and gastrointestinal symptoms. Stool samples will be collected near baseline and at the end of the intervention to explore short-term changes in markers of intestinal inflammation, microbial fermentation, and gut microbiome composition. This pilot is intended to generate feasibility and preliminary biological data that can inform the design of larger studies. It is not powered to determine effects on child growth or other clinical outcomes.
Interventions
DIETARY_SUPPLEMENTModified Therapeutic Food Formulation
A 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.
DIETARY_SUPPLEMENTNutri Listo SQ-LNS
A 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.
Sponsors
Wuqu' Kawoq, Maya Health Alliance
Cooperación Listo Maní+, S.A.
Arizona State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Participants are randomized to one of two parallel study arms: a modified food supplement or the Nutri Listo small-quantity lipid-based nutrient supplement comparator. Each participant receives the assigned product for 21 days.
Eligibility
Sex/Gender
ALL
Age
12 Months to 24 Months
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Caregiver report of frequent or severe abdominal distension or pain occurring shortly after consumption of fiber-rich foods
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability and palatability of the study product | Initial taste test (Day 0) and endline assessment (Day 22) | 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 | Days 1 through 21, with endline assessment on Day 22 | 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 | Days 1 through 21 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in fecal calprotectin concentration | Baseline to endline (Day 22) | 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 | Baseline to endline (Day 22) | 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 | Baseline to endline (Day 22) | 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 | Baseline and endline (Day 22) | Fecal pH will be assessed in stool samples collected at baseline and endline. |
| Fecal sIgA | Baseline and endline (Day 22) | Fecal sIgA will be assessed in baseline and endline stool samples as an exploratory marker related to gut integrity. This analysis is planned if resources are available. |
| Fecal alpha-1-antitrypsin (A1AT) | Baseline and endline (Day 22) | Fecal alpha-1-antitrypsin (A1AT) will be assessed in baseline and endline stool samples using a standard ELISA as an exploratory marker related to gut integrity. This analysis is planned if resources are available. |
| Fecal Reg1B | Baseline and endline (Day 22) | Fecal Reg1B will be assessed in baseline and endline stool samples using a standard ELISA as an exploratory marker related to gut integrity. This analysis is planned if resources are available. |
Countries
Guatemala
Contacts
CONTACTLee E Gaeddert, PhD
CONTACTWendy Rodriguez, MD
PRINCIPAL_INVESTIGATORLee Gaeddert, PhD
Wuqu' Kawoq, Maya Health Alliance
PRINCIPAL_INVESTIGATORWendy Rodriguez, MD
Wuqu' Kawoq, Maya Health Alliance
Outcome results
None listed