Amino Acid Supplementation in Children with Stunting (NCT06676215) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Amino Acid Supplementation in Children with Stunting
Philippines60 participantsStarted 2025-02-01
Plain-language summary
The goal of this intervention study is to determine the effects of indispensable amino acid (IAA) supplementation on children of either sex, aged 18 to 36 months. The main questions it aims to answer are:
* Does IAA supplementation affect biomarkers of Environmental Enteric Dysfunction (EED), through the Dual Sugar Lactulose/Rhamnose (L/R) test, plasma intestinal fatty acid binding protein, plasma lipopolysaccharide binding protein, fecal myeloperoxidase, fecal neopterin, and gut microbiota?
* Does IAA supplementation impact amino acid digestion, as assessed by a dual-stable isotope tracer?
* What is the weight gain and the changes in length-for-Age z-scores (LAZ) and body composition?
The researchers will compare the effects of consumption of standard complementary food with added IAA against a control group that has no added IAA through the assessment of the various biomarkers.
Participants will:
* answer questions regarding personal, demographic, anthropometric, and food intake information.
* provide biological samples, including breath, urine, stool, blood, and saliva.
* consume solutions or meals that contain sugars and/or stable isotope tracers.
* visit the FNRI and receive house visits by study staff.
* consume complementary food with or without supplement daily for 28 days.
Who can participate
Age range
18 Months – 36 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18 to 36 months old (of either sex)
* Stunted (LAZ of less than -2)
* Parent, caregiver or guardian able and willing to give written, informed consent
Exclusion Criteria:
* Wasted (WHZ of less than -2)
* Overweight (WHZ of more than 2)
* Have had diarrhea (by self-report) in the preceding month
* Sibling or twin of another participating study child (2 children of different families in the same household are both eligible)
* Have taken antibiotics in the preceding month
* Have food allergies/intolerance
* Had a serious illness within the last three (3) months or have any underlying condition which in the opinion of the pediatrician would put the subject at undue risk of failing study completion or would interfere with analysis of study results
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline in the Gut Permeability as Assessed by the Lactulose/Rhamnose (L/R) Test at 28 days
Timeframe: Baseline and end of intervention at 28 days
Trial details
NCT IDNCT06676215
SponsorFood and Nutrition Research Institute, Philippines