An interventional study of Modified Therapeutic Food Formulation and Nutri Listo SQ-LNS in Stunting of Growth and Chronic Malnutrition, sponsored by Wuqu' Kawoq, Maya Health Alliance. Not yet recruiting at 1 site in Guatemala. Open to participants aged 12 Months to 24 Months. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Wuqu' Kawoq, Maya Health Alliance · Not applicable, Interventional, and Other
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:
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:
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.
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.
Exclusion Criteria:
Participants will receive one 30-gram sachet of the modified therapeutic food formulation daily for 21 days. During the first 3 days, caregivers will divide the daily sachet into two approximately 15-gram servings. From Day 4 onward, the full daily amount may be given at one time or divided based on caregiver preference.
Dietary Supplement: Modified Therapeutic Food Formulation
Participants will receive one 30-gram sachet of Nutri Listo small-quantity lipid-based nutrient supplement daily for 21 days, with micronutrients adjusted for the study daily total. During the first 3 days, caregivers will divide the daily sachet into two approximately 15-gram servings. From Day 4 onward, the full daily amount may be given at one time or divided based on caregiver preference.
Dietary Supplement: Nutri Listo SQ-LNS
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.
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.
Also known as: Nutri Listo
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.
Time frame: Initial taste test (Day 0) and endline assessment (Day 22)
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.
Time frame: Days 1 through 21, with endline assessment on Day 22
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.
Time frame: Days 1 through 21
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.
Time frame: Baseline to endline (Day 22)
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.
Time frame: Baseline to endline (Day 22)
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.
Time frame: Baseline to endline (Day 22)
Fecal pH
Fecal pH will be assessed in stool samples collected at baseline and endline.
Time frame: Baseline and endline (Day 22)
Fecal sIgA
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.
Time frame: Baseline and endline (Day 22)
Fecal alpha-1-antitrypsin (A1AT)
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.
Time frame: Baseline and endline (Day 22)
Fecal Reg1B
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.
Time frame: Baseline and endline (Day 22)
Plan to share: Yes — De-identified individual participant data that underlie results reported in study publications will be made available to qualified researchers upon reasonable request, subject to applicable ethics, consent, privacy, and data-use requirements. De-identified microbiome sequencing data and limited non-identifying metadata will be deposited in an appropriate public repository when required by the journal or repository standards. Direct participant identifiers will not be shared.
Supporting information: Study protocol
No publications or documents are linked to this record.
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Wuqu' Kawoq, Maya Health Alliance