Stunted GrowthNCT06676215
Amino Acid Supplementation in Children with Stunting
A study testing IAA mix supplement and Complementary food comprised of rice and legumes in people with Stunted Growth, run by Food and Nutrition Research Institute, Philippines at 1 site in Philippines.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 36 months
- Conditions the study is for
- Stunted Growth
- What is being tested?
- IAA mix supplement and Complementary food comprised of rice and legumes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePhilippines
- Study dates
- 1 Feb 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Philippines1 site
Department of Science and Technology - Food and Nutrition Research Institute
City of Taguig, National Capital Region, 1631
Michael E. Serafico, PhD Chemistry, +632 8837 8113 ext. 329, michaelserafico@gmail.com
Amster Fei P. Baquiran, BS Chemistry
About this study
Official title: Efficacy of Amino Acid Supplementation on Gut Function and Nutritional Status in FIlipino Children Below Three Years Old
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?
Read more
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.
Read the detailed description
Protocol treatment will start within two weeks of enrollment to the study. Following the baseline study assessments, each participant will receive the standard complementary foods (in the control group) or standard complementary foods supplemented with IAAs (histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, and valine) (in the intervention group).
Standard complementary foods will be comprised of ingredients mainly of rice and legumes. Standard complementary foods are foods that meet the dietary needs of children 6-36 months of age.
At least three observed (controlled) feeding sessions per week will be conducted over the 4 weeks of the study to confirm that the entire supplement was consumed or confirm intake. The observed feeding will take place at the child's home or at the barangay center. Uptake on non-observed days will be based on the caregiver's report. On each intervention monitoring day, a questionnaire will also be administered to assess child morbidity that day and on the day prior. A pediatrician or an alternate medical practitioner will also be invited during the data collection where in stable isotopes will be administered. The duties and responsibilities of the physician include: medical assessment of the participant, assistance in the collection of blood samples, assessment of adverse events (if any), and provision of first aid (if needed).
In the absence of treatment delays due to adverse events, the intervention will continue for 1 month or until one of the following criteria apply:
- Child is not able to tolerate the supplement (throws up)
- Severe acute malnutrition (SAM)
- Inter-current illness that prevents further administration of treatment
- Unacceptable adverse event(s)
- Study participant voluntarily withdraws from treatment OR
- Other general or specific changes in the study participant's condition render the study participant unacceptable for further treatment in the judgment of the investigator.
For each participant, tests to be conducted at study enrolment will be spread over three days. At the end of the study, endline tests will be spread over 2 days. Baseline visits for breath, blood, urine, and fecal collection should be conducted within -3 days prior to study treatment (day 3) while endline visits should be conducted within +7 days of study treatment (day 31). The intervention will be provided in coded sachets, distributed as per convenient for local custom to best ensure compliance with a minimum of three supervised feeds per week to ensure supplement is consumed at least periodically by the child and also to assess compliance.
- Conditions
- Stunted Growth
- Being tested
- IAA mix supplement, Complementary food comprised of rice and legumes
- Keywords
- Amino Acid Supplementation, Gut Function, Nutritional Interventions, Stunting, Children Below 3 Years Old
- Medical subject headings
- Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IAA mix supplementDietary supplement
The intervention is a daily IAA dose that provides x1.5 the estimated average requirement (EAR) for a healthy child. This IAA dose will be mixed to the complementary food and will be taken once daily for 4 weeks (28 days) by the child in the intervention group.
Complementary food comprised of rice and legumesOther
Each study child will receive standard complementary food which he/she will take once daily for 4 weeks (28 days)
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | complementary food supplemented with indispensable amino acid (IAA) mix Receives: Dietary Supplement: IAA mix supplement; Other: Complementary food comprised of rice and legumes |
| Control Group | Experimental | complementary food without IAA mix Receives: Other: Complementary food comprised of rice and legumes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the Gut Permeability as Assessed by the Lactulose/Rhamnose (L/R) Test at 28 days
Measured: Baseline and end of intervention at 28 days
Secondary outcomes (6)
Change from Baseline in Protein Absorption as Assessed by the Dual Stable Isotope Tracer (DSIT) Technique at 28 days
Measured: Baseline and end of intervention at 28 days
Change from Baseline in Gut Digestive Capacity Measured by the 13C-Sucrose Breath Test (SBT) at 28 days
Measured: Baseline and end of intervention at 28 days
Change from Baseline in Gut Function Based on Plasma LPS-Binding Protein (LPSBP) Concentration at 28 days
Measured: Baseline and end of intervention at 28 days
Change from Baseline in Gut Function Based on Intestinal Fatty Acid Binding Protein (iFABP) Concentration at 28 days
Measured: Baseline and end of intervention at 28 days
Change from Baseline in Gut Inflammation Based on Fecal Myeloperoxidase Concentration at 28 days
Measured: Baseline and end of intervention at 28 days
Change from Baseline in Gut Inflammation Based on Fecal Neopterin Concentration at 28 days
Measured: Baseline and end of intervention at 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start1 Feb 2025 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (53)Papers the sponsor has linked to this study.
- Other trials for Stunted GrowthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Food and Nutrition Research Institute, Philippines
- Sponsor type
- Other government
- Collaborators
- International Atomic Energy Agency, University of Glasgow, Ghana Atomic Energy Commission, Kamuzu University of Health Sciences, University of Zambia, Rutgers, The State University of New Jersey, St. John's Research Institute, cnesten, Morocco
- Responsible party
- Principal investigator, Amster Fei Baquiran, Food and Nutrition Research Institute, Philippines
- Investigators
- Amster Fei P. Baquiran, BS Chemistry, Principal investigator, Department of Science and Technology Food and Nutrition Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06676215
- Sponsor's protocol ID
- FIERC-2023-004
- Status last verified
- Oct 2024
- First submitted
- 4 Oct 2024
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abtahi S, Sailer A, Roland JT, Haest X, Chanez-Paredes SD, Ahmad K, Sadiq K, Iqbal NT, Ali SA, Turner JR. Intestinal Epithelial Digestive, Transport, and Barrier Protein Expression Is Increased in Environmental Enteric Dysfunction. Lab Invest. 2023 Apr;103(4):100036. doi: 10.1016/j.labinv.2022.100036. Epub 2023 Jan 10.
PubMed 36870290Antiporta DA, Ambikapathi R, Bose A, Maciel B, Mahopo TC, Patil C, Turab A, Olortegui MP, Islam M, Bauck A, McCormick B, Caulfield LE; MAL-ED Network Investigators. Micronutrient intake and the probability of nutrient adequacy among children 9-24 months of age: results from the MAL-ED birth cohort study. Public Health Nutr. 2021 Jun;24(9):2592-2602. doi: 10.1017/S1368980020000877. Epub 2020 Jul 2.
PubMed 32611463Arnold BF, Null C, Luby SP, Unicomb L, Stewart CP, Dewey KG, Ahmed T, Ashraf S, Christensen G, Clasen T, Dentz HN, Fernald LC, Haque R, Hubbard AE, Kariger P, Leontsini E, Lin A, Njenga SM, Pickering AJ, Ram PK, Tofail F, Winch PJ, Colford JM Jr. Cluster-randomised controlled trials of individual and combined water, sanitation, hygiene and nutritional interventions in rural Bangladesh and Kenya: the WASH Benefits study design and rationale. BMJ Open. 2013 Aug 30;3(8):e003476. doi: 10.1136/bmjopen-2013-003476.
PubMed 23996605Arsenault JE, Brown KH. Effects of protein or amino-acid supplementation on the physical growth of young children in low-income countries. Nutr Rev. 2017 Sep 1;75(9):699-717. doi: 10.1093/nutrit/nux027.
PubMed 28938793Budge S, Parker AH, Hutchings PT, Garbutt C. Environmental enteric dysfunction and child stunting. Nutr Rev. 2019 Apr 1;77(4):240-253. doi: 10.1093/nutrit/nuy068.
PubMed 30753710Capanzana MV, Aguila DV, Gironella GMP, Montecillo KV. Nutritional status of children ages 0-5 and 5-10 years old in households headed by fisherfolks in the Philippines. Arch Public Health. 2018 Apr 16;76:24. doi: 10.1186/s13690-018-0267-3. eCollection 2018.
PubMed 29686867Denno DM, VanBuskirk K, Nelson ZC, Musser CA, Hay Burgess DC, Tarr PI. Use of the lactulose to mannitol ratio to evaluate childhood environmental enteric dysfunction: a systematic review. Clin Infect Dis. 2014 Nov 1;59 Suppl 4:S213-9. doi: 10.1093/cid/ciu541.
PubMed 25305289Devi S, Varkey A, Sheshshayee MS, Preston T, Kurpad AV. Measurement of protein digestibility in humans by a dual-tracer method. Am J Clin Nutr. 2018 Jun 1;107(6):984-991. doi: 10.1093/ajcn/nqy062.
PubMed 29771297Dewey KG, Brown KH. Update on technical issues concerning complementary feeding of young children in developing countries and implications for intervention programs. Food Nutr Bull. 2003 Mar;24(1):5-28. doi: 10.1177/156482650302400102.
PubMed 12664525Elango R. Tolerable Upper Intake Level for Individual Amino Acids in Humans: A Narrative Review of Recent Clinical Studies. Adv Nutr. 2023 Jul;14(4):885-894. doi: 10.1016/j.advnut.2023.04.004. Epub 2023 Apr 14.
PubMed 37062432Fahim SM, Das S, Sanin KI, Gazi MA, Mahfuz M, Islam MM, Ahmed T. Association of Fecal Markers of Environmental Enteric Dysfunction with Zinc and Iron Status among Children at First Two Years of Life in Bangladesh. Am J Trop Med Hyg. 2018 Aug;99(2):489-494. doi: 10.4269/ajtmh.17-0985. Epub 2018 Jun 7.
PubMed 29893201Faubion WA, Camilleri M, Murray JA, Kelly P, Amadi B, Kosek MN, Enders F, Larson J, Grover M, Boe G, Dyer R, Singh R. Improving the detection of environmental enteric dysfunction: a lactulose, rhamnose assay of intestinal permeability in children aged under 5 years exposed to poor sanitation and hygiene. BMJ Glob Health. 2016 Jul 4;1(1):e000066. doi: 10.1136/bmjgh-2016-000066. eCollection 2016.
PubMed 28588929Ghosh S, Suri D, Uauy R. Assessment of protein adequacy in developing countries: quality matters. Br J Nutr. 2012 Aug;108 Suppl 2:S77-87. doi: 10.1017/S0007114512002577.
PubMed 23107551Gibson RS, Ferguson EL, Lehrfeld J. Complementary foods for infant feeding in developing countries: their nutrient adequacy and improvement. Eur J Clin Nutr. 1998 Oct;52(10):764-70. doi: 10.1038/sj.ejcn.1600645.
PubMed 9805226Goron A, Moinard C. Amino acids and sport: a true love story? Amino Acids. 2018 Aug;50(8):969-980. doi: 10.1007/s00726-018-2591-x. Epub 2018 May 31.
PubMed 29855718
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Amino Acid Supplementation on Gut Function and Nutritional Status in FIlipino Children Below Three Years Old
- ClinicalTrials.gov ID
- NCT06676215
- Acronym / sponsor ID
- FIERC-2023-004
- Conditions
- Stunted Growth
- Keywords
- Amino Acid Supplementation, Gut Function, Nutritional Interventions, Stunting, Children Below 3 Years Old
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Food and Nutrition Research Institute, PhilippinesOther government
- Collaborators
- International Atomic Energy Agency, University of Glasgow, Ghana Atomic Energy Commission, Kamuzu University of Health Sciences, University of Zambia, Rutgers, The State University of New Jersey, St. John's Research Institute, cnesten, Morocco
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 6 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Protocol treatment will start within two weeks of enrollment to the study. Following the baseline study assessments, each participant will receive the standard complementary foods (in the control group) or standard complementary foods supplemented with IAAs (histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, and valine) (in the intervention group).
Standard complementary foods will be comprised of ingredients mainly of rice and legumes. Standard complementary foods are foods that meet the dietary needs of children 6-36 months of age.
At least three observed (controlled) feeding sessions per week will be conducted over the 4 weeks of the study to confirm that the entire supplement was consumed or confirm intake. The observed feeding will take place at the child's home or at the barangay center. Uptake on non-observed days will be based on the caregiver's report. On each intervention monitoring day, a questionnaire will also be administered to assess child morbidity that day and on the day prior. A pediatrician or an alternate medical practitioner will also be invited during the data collection where in stable isotopes will be administered. The duties and responsibilities of the physician include: medical assessment of the participant, assistance in the collection of blood samples, assessment of adverse events (if any), and provision of first aid (if needed).
In the absence of treatment delays due to adverse events, the intervention will continue for 1 month or until one of the following criteria apply:
- Child is not able to tolerate the supplement (throws up)
- Severe acute malnutrition (SAM)
- Inter-current illness that prevents further administration of treatment
- Unacceptable adverse event(s)
- Study participant voluntarily withdraws from treatment OR
- Other general or specific changes in the study participant's condition render the study participant unacceptable for further treatment in the judgment of the investigator.
For each participant, tests to be conducted at study enrolment will be spread over three days. At the end of the study, endline tests will be spread over 2 days. Baseline visits for breath, blood, urine, and fecal collection should be conducted within -3 days prior to study treatment (day 3) while endline visits should be conducted within +7 days of study treatment (day 31). The intervention will be provided in coded sachets, distributed as per convenient for local custom to best ensure compliance with a minimum of three supervised feeds per week to ensure supplement is consumed at least periodically by the child and also to assess compliance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Dietary Supplement: IAA mix supplement, Other: Complementary food comprised of rice and legumescomplementary food supplemented with indispensable amino acid (IAA) mix |
| Control Group | Experimental | Other: Complementary food comprised of rice and legumescomplementary food without IAA mix |
Who may qualify
- Ages
- 18 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IAA mix supplementThe intervention is a daily IAA dose that provides x1.5 the estimated average requirement (EAR) for a healthy child. This IAA dose will be mixed to the complementary food and will be taken once daily for 4 weeks (28 days) by the child in the intervention group. | Dietary supplement | Intervention Arm |
| Complementary food comprised of rice and legumesEach study child will receive standard complementary food which he/she will take once daily for 4 weeks (28 days) | Other | Control Group, Intervention Arm |
Primary outcome
Change from Baseline in the Gut Permeability as Assessed by the Lactulose/Rhamnose (L/R) Test at 28 days
Time frame: Baseline and end of intervention at 28 days
6 secondary outcomes
Change from Baseline in Protein Absorption as Assessed by the Dual Stable Isotope Tracer (DSIT) Technique at 28 days
Time frame: Baseline and end of intervention at 28 days
Change from Baseline in Gut Digestive Capacity Measured by the 13C-Sucrose Breath Test (SBT) at 28 days
Time frame: Baseline and end of intervention at 28 days
Change from Baseline in Gut Function Based on Plasma LPS-Binding Protein (LPSBP) Concentration at 28 days
Time frame: Baseline and end of intervention at 28 days
Change from Baseline in Gut Function Based on Intestinal Fatty Acid Binding Protein (iFABP) Concentration at 28 days
Time frame: Baseline and end of intervention at 28 days
Change from Baseline in Gut Inflammation Based on Fecal Myeloperoxidase Concentration at 28 days
Time frame: Baseline and end of intervention at 28 days
Change from Baseline in Gut Inflammation Based on Fecal Neopterin Concentration at 28 days
Time frame: Baseline and end of intervention at 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Background: PubMed 36870290Abtahi S, Sailer A, Roland JT, Haest X, Chanez-Paredes SD, Ahmad K, Sadiq K, Iqbal NT, Ali SA, Turner JR. Intestinal Epithelial Digestive, Transport, and Barrier Protein Expression Is Increased in Environmental Enteric Dysfunction. Lab Invest. 2023 Apr;103(4):100036. doi: 10.1016/j.labinv.2022.100036. Epub 2023 Jan 10.
- Background: PubMed 32611463Antiporta DA, Ambikapathi R, Bose A, Maciel B, Mahopo TC, Patil C, Turab A, Olortegui MP, Islam M, Bauck A, McCormick B, Caulfield LE; MAL-ED Network Investigators. Micronutrient intake and the probability of nutrient adequacy among children 9-24 months of age: results from the MAL-ED birth cohort study. Public Health Nutr. 2021 Jun;24(9):2592-2602. doi: 10.1017/S1368980020000877. Epub 2020 Jul 2.
- Background: PubMed 23996605Arnold BF, Null C, Luby SP, Unicomb L, Stewart CP, Dewey KG, Ahmed T, Ashraf S, Christensen G, Clasen T, Dentz HN, Fernald LC, Haque R, Hubbard AE, Kariger P, Leontsini E, Lin A, Njenga SM, Pickering AJ, Ram PK, Tofail F, Winch PJ, Colford JM Jr. Cluster-randomised controlled trials of individual and combined water, sanitation, hygiene and nutritional interventions in rural Bangladesh and Kenya: the WASH Benefits study design and rationale. BMJ Open. 2013 Aug 30;3(8):e003476. doi: 10.1136/bmjopen-2013-003476.
- Background: PubMed 28938793Arsenault JE, Brown KH. Effects of protein or amino-acid supplementation on the physical growth of young children in low-income countries. Nutr Rev. 2017 Sep 1;75(9):699-717. doi: 10.1093/nutrit/nux027.
- Background: PubMed 30753710Budge S, Parker AH, Hutchings PT, Garbutt C. Environmental enteric dysfunction and child stunting. Nutr Rev. 2019 Apr 1;77(4):240-253. doi: 10.1093/nutrit/nuy068.
- Background: PubMed 29686867Capanzana MV, Aguila DV, Gironella GMP, Montecillo KV. Nutritional status of children ages 0-5 and 5-10 years old in households headed by fisherfolks in the Philippines. Arch Public Health. 2018 Apr 16;76:24. doi: 10.1186/s13690-018-0267-3. eCollection 2018.
- Background: PubMed 25305289Denno DM, VanBuskirk K, Nelson ZC, Musser CA, Hay Burgess DC, Tarr PI. Use of the lactulose to mannitol ratio to evaluate childhood environmental enteric dysfunction: a systematic review. Clin Infect Dis. 2014 Nov 1;59 Suppl 4:S213-9. doi: 10.1093/cid/ciu541.
- Background: PubMed 29771297Devi S, Varkey A, Sheshshayee MS, Preston T, Kurpad AV. Measurement of protein digestibility in humans by a dual-tracer method. Am J Clin Nutr. 2018 Jun 1;107(6):984-991. doi: 10.1093/ajcn/nqy062.
- Background: PubMed 12664525Dewey KG, Brown KH. Update on technical issues concerning complementary feeding of young children in developing countries and implications for intervention programs. Food Nutr Bull. 2003 Mar;24(1):5-28. doi: 10.1177/156482650302400102.
- Background: PubMed 37062432Elango R. Tolerable Upper Intake Level for Individual Amino Acids in Humans: A Narrative Review of Recent Clinical Studies. Adv Nutr. 2023 Jul;14(4):885-894. doi: 10.1016/j.advnut.2023.04.004. Epub 2023 Apr 14.
- Background: PubMed 29893201Fahim SM, Das S, Sanin KI, Gazi MA, Mahfuz M, Islam MM, Ahmed T. Association of Fecal Markers of Environmental Enteric Dysfunction with Zinc and Iron Status among Children at First Two Years of Life in Bangladesh. Am J Trop Med Hyg. 2018 Aug;99(2):489-494. doi: 10.4269/ajtmh.17-0985. Epub 2018 Jun 7.
- Background: PubMed 28588929Faubion WA, Camilleri M, Murray JA, Kelly P, Amadi B, Kosek MN, Enders F, Larson J, Grover M, Boe G, Dyer R, Singh R. Improving the detection of environmental enteric dysfunction: a lactulose, rhamnose assay of intestinal permeability in children aged under 5 years exposed to poor sanitation and hygiene. BMJ Glob Health. 2016 Jul 4;1(1):e000066. doi: 10.1136/bmjgh-2016-000066. eCollection 2016.
Related trials for Stunted Growth
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
RecruitingObservational study
Study of Proteus Syndrome and Related Congenital Disorders
Proteus Syndrome, PIK3CA Related Overgrowth Spectrum
Active, not recruitingPhase 2
Maternal Probiotic Intervention to Improve Gut Health-Trial II-Pakistan
Environmental Enteric Dysfunction (EED), Stunting
Recruiting
STV Analysis Versus Visual Evaluation of Cardiotocography in FGR
Fetal Growth Retardation
RecruitingPhase 2
Statin Intervention for Severe Early-Onset Placental Insufficiency. (STATIN-PRE Trial)
Preeclampsia (PE), Intrauterine Growth Restriction (IUGR)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amster Fei P. Baquiran, BS Chemistry principal investigator
Department of Science and Technology Food and Nutrition Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IAA mix supplement and Complementary food comprised of rice and legumes in people with Stunted Growth, run by Food and Nutrition Research Institute, Philippines at 1 site in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amster Fei P. Baquiran, BS Chemistry (+632 8837 8113 ext. 341, afpbaquiran@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the Gut Permeability as Assessed by the Lactulose/Rhamnose (L/R) Test at 28 days (time frame: Baseline and end of intervention at 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06676215, which also lists 53 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2024.