Faltering GrowthLOTUSNCT07549360
Leveraging Optimal Tolerance in Undernourished Infants to Support Growth
A study testing Infant Formula in people with Faltering Growth and Failure to Thrive, run by Dutch Medical Food at 1 site in Thailand.
Trial summary
The goal of this study is to learn if InfaCore (IC) an energy and nutrient dense formulation (ENDF) can improve growth and tolerance in infants with or at risk of growth faltering when fed IC. Read more about this study
- Who is it for?
- Ages 1 month to 12 months
- Conditions the study is for
- Faltering Growth, Failure to Thrive
- What is being tested?
- Infant Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteThailand
- Study dates
- 15 May 2026to 15 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 month to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants aged from 1 month to </=12 months of age
- Infants taking at least 50% of daily intake from infant formula
- Diagnosis of FG (a fall in WAZ of ≥1.0 SD over 1 month or more - not including the first 2 weeks after birth) or risk of FG (static weight for >/= 1 month)
- Infants >/=37 weeks gestation at time of recruitment
- Parent/ legal guardian willing to provide written informed consent
Who cannot join
- Exclusively Breastfed infants
- Infants with other medical problems that might independently affect intake (oral or otherwise) or who have specific nutrient needs not met by IC e.g. some gastrointestinal malformations, some renal and liver conditions, inborn errors of metabolism, galactosemia
- Infants on total parenteral nutrition
- Infants with cow milk protein allergy
- Infants with soy allergy
- Infants who participated in other studies within 2 weeks prior to recruitment
Show all 10Show fewer
- Situations where the investigator has concerns about the willingness or ability of the parents/caregivers to comply with protocol requirements
- Infants who are on a vegan diet
- Infants who are allergic to fish
- Infants born preterm <37 weeks gestation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Eakkarin Mekangkul, MD contact
Thailand1 site
Department of Pediatrics, Faculty of Medicine, Chulalongkorn University
Bangkok, Bangkok, 10330
Chonnikant Visuthranukul, MD, PhD, +66 2256 4000 ext. 4903, deknet@gmail.com
About this study
The goal of this study is to learn if InfaCore (IC) an energy and nutrient dense formulation (ENDF) can improve growth and tolerance in infants with or at risk of growth faltering when fed IC.
Read the detailed description
Rationale: The definition of FG/FTT was established by a group of experts in a report published in 2023 (Cooke et al., 2023). In this report they agreed a fall in weight-for-age z-score (WAZ) of ≥1.0 SD over a period of 1 or more months (excluding the first 2 weeks after birth) which includes at least 2-3 growth measurements (Cooke et al., 2023). It is also important to consider infants at risk who have static weight for extended periods e.g., >/=4 weeks. FG/FTT affects different populations and is estimated to be 10% of infants globally.
InfaCore (IC) an energy and nutrient dense formulation is indicated for infants and young children with FG/FTT defined above or for those at risk of developing e.g., with static weight for extended periods. At risk infants might include some or all of the following those with congenital heart disease (CHD) admitted for surgical procedures, those with critical illness (CI) or on the PICU, infants cystic fibrosis (CF) or other respiratory conditions including chronic lung disease (CLD), some forms of severe cerebral palsy (CP), and those requiring a surgical procedure or post-surgery.
Objective: To demonstrate growth and tolerance in infants with or at risk of growth faltering when fed IC an Energy and Nutrient Dense Formula (ENDF).
Study design: A prospective, single-centre, single-arm open label pilot study to show growth and tolerance in infants with/at risk of FG/FTT when fed an ENDF for 8 weeks.
- Conditions
- Faltering Growth, Failure to Thrive
- Being tested
- Infant Formula
- Keywords
- Faltering Growth, Failure to Thrive, Energy and Nutrient Dense Formula, LOTUS, Infacore
- Medical subject headings
- Failure to Thrive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant FormulaOther
Also called Energy and Nutrient Dense Infant Formula (ENDF)
Prospective, single-center, single-arm open label pilot study to show growth and tolerance in infants with/at risk of FG/FTT when fed an ENDF for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Active comparator | Not described Receives: Other: Infant Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
Body Weight
Measured: 8 weeks
Change in body weight
The primary outcome is the change in weight-for-age Z-score from baseline to study completion, regardless of whether the value increases or decreases.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start15 May 2026 (estimated)
- Primary completion15 May 2026 (estimated)
- Study completion15 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Faltering 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
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single-center, single-arm open label pilot study
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dutch Medical Food
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07549360
- Sponsor's protocol ID
- LOTUSV10
- Acronym
- LOTUS
- Status last verified
- Apr 2026
- First submitted
- 18 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhang H, Gu Y, Mi Y, Jin Y, Fu W, Latour JM. High-energy nutrition in paediatric cardiac critical care patients: a randomized controlled trial. Nurs Crit Care. 2019 Mar;24(2):97-102. doi: 10.1111/nicc.12400. Epub 2018 Dec 9.
PubMed 30548121World Health Organization (WHO). Child Growth Standards. [Online]. Available from: https://www.who.int/tools/child-growth-standards/standards/weight-for-age (Accessed August 2025).
Joint WHO/FAO/UNU Expert Consultation. Protein and amino acid requirements in human nutrition. World Health Organ Tech Rep Ser. 2007;(935):1-265, back cover.
PubMed 18330140Valla FV, Berthiller J, Gaillard-Le-Roux B, Ford-Chessel C, Ginhoux T, Rooze S, Cour-Andlauer F, Meyer R, Javouhey E. Faltering growth in the critically ill child: prevalence, risk factors, and impaired outcome. Eur J Pediatr. 2018 Mar;177(3):345-353. doi: 10.1007/s00431-017-3062-1. Epub 2017 Dec 14.
PubMed 29243190Shoham J, Duffield A. Proceedings of the World Health Organization/ UNICEF/World Food Programme/United Nations High Commissioner for Refugees Consultation on the management of moderate malnutrition in children under 5 years of age. Food Nutr Bull. 2009 Sep;30(3 Suppl):S464-74. doi: 10.1177/15648265090303S306. No abstract available.
PubMed 19998867Pineda D, Bingham R, Gates A, Thompson AB, Stansfield BK. Osmolality of fortified donor human milk: An experimental study. JPEN J Parenter Enteral Nutr. 2024 Jan;48(1):57-63. doi: 10.1002/jpen.2558. Epub 2023 Sep 17.
PubMed 37608726Novak EM, Innis SM. Impact of maternal dietary n-3 and n-6 fatty acids on milk medium-chain fatty acids and the implications for neonatal liver metabolism. Am J Physiol Endocrinol Metab. 2011 Nov;301(5):E807-17. doi: 10.1152/ajpendo.00225.2011. Epub 2011 Jul 26.
PubMed 21791621Jackson AA. Protein requirements for catch-up growth. Proc Nutr Soc. 1990 Oct;49(3):507-16. doi: 10.1079/pns19900059. No abstract available.
PubMed 2080182Hulst JM, Zwart H, Hop WC, Joosten KF. Dutch national survey to test the STRONGkids nutritional risk screening tool in hospitalized children. Clin Nutr. 2010 Feb;29(1):106-11. doi: 10.1016/j.clnu.2009.07.006. Epub 2009 Aug 13.
PubMed 19682776Food And Nutrition (FAO). Technical report series 1. 2001. [Online]. Available from: https://openknowledge.fao.org/server/api/core/bitstreams/65875dc7-f8c5-4a70-b0e1-f429793860ae/content (Accessed August 2025)
Eveleens RD, Dungen DK, Verbruggen SCAT, Hulst JM, Joosten KFM. Weight improvement with the use of protein and energy enriched nutritional formula in infants with a prolonged PICU stay. J Hum Nutr Diet. 2019 Feb;32(1):3-10. doi: 10.1111/jhn.12603. Epub 2018 Oct 14.
PubMed 30318663Evans S, Twaissi H, Daly A, Davies P, Macdonald A. Should high-energy infant formula be given at full strength from its first day of usage? J Hum Nutr Diet. 2006 Jun;19(3):191-7; quiz 199-201. doi: 10.1111/j.1365-277X.2006.00689.x.
PubMed 16756534Ellis ZM, Tan HSG, Embleton ND, Sangild PT, van Elburg RM. Milk feed osmolality and adverse events in newborn infants and animals: a systematic review. Arch Dis Child Fetal Neonatal Ed. 2019 May;104(3):F333-F340. doi: 10.1136/archdischild-2018-315946. Epub 2018 Dec 6.
PubMed 30523072EUROPEAN DIRECTIVE - COMMISSION DELEGATED REGULATION (EU) (2016) - of 25 September 2015. Supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for food for special medical purposes. 128. [Online]. Available from: file:///C:/Users/garve/Downloads/CELEX_32016R0128_EN_TXT.pdf
EUROPEAN DIRECTIVE - COMMISSION DELEGATED REGULATION (EU) (2016). Compositional and information requirements for infant formula and follow-on formula. 127. [Online]. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32016R0127&qid=1650372664210&from=EN. (Accessed 2025)
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Optimal Tolerance in Undernourished Infants to Support Growth
- ClinicalTrials.gov ID
- NCT07549360
- Acronym / sponsor ID
- LOTUS / LOTUSV10
- Conditions
- Faltering Growth, Failure to Thrive
- Keywords
- Faltering Growth, Failure to Thrive, Energy and Nutrient Dense Formula, LOTUS, Infacore
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Dutch Medical FoodIndustry (pharma, biotech, devices)
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 24 Apr 2026 (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 study is to learn if InfaCore (IC) an energy and nutrient dense formulation (ENDF) can improve growth and tolerance in infants with or at risk of growth faltering when fed IC.
Detailed description
Rationale: The definition of FG/FTT was established by a group of experts in a report published in 2023 (Cooke et al., 2023). In this report they agreed a fall in weight-for-age z-score (WAZ) of ≥1.0 SD over a period of 1 or more months (excluding the first 2 weeks after birth) which includes at least 2-3 growth measurements (Cooke et al., 2023). It is also important to consider infants at risk who have static weight for extended periods e.g., >/=4 weeks. FG/FTT affects different populations and is estimated to be 10% of infants globally.
InfaCore (IC) an energy and nutrient dense formulation is indicated for infants and young children with FG/FTT defined above or for those at risk of developing e.g., with static weight for extended periods. At risk infants might include some or all of the following those with congenital heart disease (CHD) admitted for surgical procedures, those with critical illness (CI) or on the PICU, infants cystic fibrosis (CF) or other respiratory conditions including chronic lung disease (CLD), some forms of severe cerebral palsy (CP), and those requiring a surgical procedure or post-surgery.
Objective: To demonstrate growth and tolerance in infants with or at risk of growth faltering when fed IC an Energy and Nutrient Dense Formula (ENDF).
Study design: A prospective, single-centre, single-arm open label pilot study to show growth and tolerance in infants with/at risk of FG/FTT when fed an ENDF for 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single-center, single-arm open label pilot study
| Arm | Type | Receives |
|---|---|---|
| Interventional | Active comparator | Other: Infant Formula |
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Infants aged from 1 month to </=12 months of age
- Infants taking at least 50% of daily intake from infant formula
- Diagnosis of FG (a fall in WAZ of ≥1.0 SD over 1 month or more - not including the first 2 weeks after birth) or risk of FG (static weight for >/= 1 month)
- Infants >/=37 weeks gestation at time of recruitment
- Parent/ legal guardian willing to provide written informed consent
Key exclusion criteria (10 listed)
- Exclusively Breastfed infants
- Infants with other medical problems that might independently affect intake (oral or otherwise) or who have specific nutrient needs not met by IC e.g. some gastrointestinal malformations, some renal and liver conditions, inborn errors of metabolism, galactosemia
- Infants on total parenteral nutrition
- Infants with cow milk protein allergy
- Infants with soy allergy
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 |
|---|---|---|
| Infant FormulaAlso: Energy and Nutrient Dense Infant Formula (ENDF)Prospective, single-center, single-arm open label pilot study to show growth and tolerance in infants with/at risk of FG/FTT when fed an ENDF for 8 weeks. | Other | Interventional |
Primary outcome
Body Weight
Time frame: 8 weeks
Body Weight
Change in body weight
Time frame: 8 weeks
The primary outcome is the change in weight-for-age Z-score from baseline to study completion, regardless of whether the value increases or decreases.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Background: PubMed 30548121Zhang H, Gu Y, Mi Y, Jin Y, Fu W, Latour JM. High-energy nutrition in paediatric cardiac critical care patients: a randomized controlled trial. Nurs Crit Care. 2019 Mar;24(2):97-102. doi: 10.1111/nicc.12400. Epub 2018 Dec 9.
- BackgroundWorld Health Organization (WHO). Child Growth Standards. [Online]. Available from: https://www.who.int/tools/child-growth-standards/standards/weight-for-age (Accessed August 2025).
- Background: PubMed 18330140Joint WHO/FAO/UNU Expert Consultation. Protein and amino acid requirements in human nutrition. World Health Organ Tech Rep Ser. 2007;(935):1-265, back cover.
- Background: PubMed 29243190Valla FV, Berthiller J, Gaillard-Le-Roux B, Ford-Chessel C, Ginhoux T, Rooze S, Cour-Andlauer F, Meyer R, Javouhey E. Faltering growth in the critically ill child: prevalence, risk factors, and impaired outcome. Eur J Pediatr. 2018 Mar;177(3):345-353. doi: 10.1007/s00431-017-3062-1. Epub 2017 Dec 14.
- Background: PubMed 19998867Shoham J, Duffield A. Proceedings of the World Health Organization/ UNICEF/World Food Programme/United Nations High Commissioner for Refugees Consultation on the management of moderate malnutrition in children under 5 years of age. Food Nutr Bull. 2009 Sep;30(3 Suppl):S464-74. doi: 10.1177/15648265090303S306. No abstract available.
- Background: PubMed 37608726Pineda D, Bingham R, Gates A, Thompson AB, Stansfield BK. Osmolality of fortified donor human milk: An experimental study. JPEN J Parenter Enteral Nutr. 2024 Jan;48(1):57-63. doi: 10.1002/jpen.2558. Epub 2023 Sep 17.
- Background: PubMed 21791621Novak EM, Innis SM. Impact of maternal dietary n-3 and n-6 fatty acids on milk medium-chain fatty acids and the implications for neonatal liver metabolism. Am J Physiol Endocrinol Metab. 2011 Nov;301(5):E807-17. doi: 10.1152/ajpendo.00225.2011. Epub 2011 Jul 26.
- Background: PubMed 2080182Jackson AA. Protein requirements for catch-up growth. Proc Nutr Soc. 1990 Oct;49(3):507-16. doi: 10.1079/pns19900059. No abstract available.
- Background: PubMed 19682776Hulst JM, Zwart H, Hop WC, Joosten KF. Dutch national survey to test the STRONGkids nutritional risk screening tool in hospitalized children. Clin Nutr. 2010 Feb;29(1):106-11. doi: 10.1016/j.clnu.2009.07.006. Epub 2009 Aug 13.
- BackgroundFood And Nutrition (FAO). Technical report series 1. 2001. [Online]. Available from: https://openknowledge.fao.org/server/api/core/bitstreams/65875dc7-f8c5-4a70-b0e1-f429793860ae/content (Accessed August 2025)
- Background: PubMed 30318663Eveleens RD, Dungen DK, Verbruggen SCAT, Hulst JM, Joosten KFM. Weight improvement with the use of protein and energy enriched nutritional formula in infants with a prolonged PICU stay. J Hum Nutr Diet. 2019 Feb;32(1):3-10. doi: 10.1111/jhn.12603. Epub 2018 Oct 14.
- Background: PubMed 16756534Evans S, Twaissi H, Daly A, Davies P, Macdonald A. Should high-energy infant formula be given at full strength from its first day of usage? J Hum Nutr Diet. 2006 Jun;19(3):191-7; quiz 199-201. doi: 10.1111/j.1365-277X.2006.00689.x.
- Individual participant dataSharing planned: Undecided
Related trials for Faltering Growth
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
RecruitingPhase 3
Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children
Growth Disorders, Growth Failure
Active, not recruiting
Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk
Prematurity; Extreme, Feeding Disorder Neonatal
Not yet recruitingObservational study
Predictors of Postnatal Growth Failure in Preterm Infants
Premature Birth, Growth Failure
Recruiting
Targeted Fortification of Donor Breast Milk in Preterm Infants
Prematurity; Extreme, Failure to Thrive in Newborn
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.
Eakkarin Mekangkul, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant Formula in people with Faltering Growth and Failure to Thrive, run by Dutch Medical Food at 1 site in Thailand.
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 5 inclusion and 10 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: opening soon, as of the sponsor's last update on 24 Apr 2026. 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 Thailand. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chonnikant Visuthranukul, MD, PhD (+66 2256 4000 ext. 4903, deknet@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Weight (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 NCT07549360, which also lists 20 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 24 Apr 2026.