Complex Conditions, Including Impairment of the GI TractNICCNCT04265729
Neocate In Infants and Children With Complex Conditions
A study testing Neocate Infant and Junior marketed products in people with Complex Conditions, Including Impairment of the GI Tract, run by Nutricia Research at 4 sites in 3 countries.
Trial summary
Infants and young children up to 10 years of age with a complex condition involving the gastrointestinal tract are at risk of poor nutritional status, including faltering growth. Due to the complex condition, standard nutrition is often not tolerated and causes gastrointestinal symptoms. Read more about this study
- Who is it for?
- Ages 0 to 10 years
- Conditions the study is for
- Complex Conditions, Including Impairment of the GI Tract
- What is being tested?
- Neocate Infant and Junior marketed products
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 1 Jul 2021to 24 Jul 2023
- 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 0 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants and young children aged from 0 up to and including 10 years of age.
- Severe impairment of at least 1 organ system
- Impairment of the gastrointestinal tract, i.e. gastrointestinal disease, congenital abnormality, surgical resection, or gastrointestinal dysfunction (including symptoms of gastrointestinal dysmotility or malabsorption).
- Receiving at least 75% of their energy intake from Neocate (Neocate Infant or Junior powdered (marketed) product) at the time of study entry (V1).
- Expected to receive at least 75% of their energy intake from the study product for at least 4 weeks from study entry (V1).
- Written informed consent provided by parents/guardians and assent by the child, if applicable, according to local law.
Who cannot join
- Infants born with a gestational age <37 weeks that are <40 weeks corrected age at the time of study entry (V1).
- Infants or children with endoscopically confirmed eosinophilic oesophagitis and prescribed an amino acid-based formula only for the management of the eosinophilic oesophagitis.
- Infants or children with a medical diagnosis that includes only (suspected) cow's milk allergy and/or multiple food allergy.
- Infants or children with renal dysfunction, e.g. acute or chronic kidney failure or kidney cancer.
- Infants or children with thyroid disorder or parathyroid disorder.
- Expected to receive parenteral nutrition during intervention from study entry (V1).
- Participation in any other studies involving investigational or marketed products concomitantly or within 1 month prior to study entry (V1).
- Investigator's uncertainty about the willingness or ability of the parents/guardians to comply with the protocol requirements.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
United States2 sites
GI Care for Kids
Atlanta, Georgia, 30342
Prisma Health - Upstate
Greenville, South Carolina, 29615
About this study
Official title: An Open-label, Explorative, Post Launch Study of Neocate Amino Acid-based Feeds to Evaluate Nutritional Status and Gastrointestinal Tolerance in Infants and Children With Complex Conditions
Infants and young children up to 10 years of age with a complex condition involving the gastrointestinal tract are at risk of poor nutritional status, including faltering growth. Due to the complex condition, standard nutrition is often not tolerated and causes gastrointestinal symptoms.
Formulas in which protein is replaced by its smallest elements, amino acids are easier for the body to digest and absorb. These formulas might be tolerated better and reduce gastrointestinal symptoms in infants and young children with complex conditions.
The objectives of the present, exploratory study are to gain clinical evidence related to the nutritional status and gastrointestinal tolerance in infants and young children with complex conditions receiving Neocate as their primary source of nutrition. Additional objectives are to describe the nutritional and pharmacological management of these infants and young children. Study duration for each participant will be 52 weeks at maximum.
- Being tested
- Neocate Infant and Junior marketed products
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neocate Infant and Junior marketed productsDietary supplement
use of Neocate Infant and Junior marketed products
| Study group | Role | What they receive |
|---|---|---|
| single test product arm | Other | use of Neocate Infant and Junior marketed products (product type depending on subject's age and condition) Receives: Dietary Supplement: Neocate Infant and Junior marketed products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exploratory: Weight
Weight [in g/kg]
Measured: 0 weeks
Exploratory: Weight
Weight [in g/kg]
Measured: 4 weeks
Exploratory: Weight
Weight [in g/kg]
Measured: 16 weeks
Exploratory: Weight
Weight [in g/kg]
Measured: 52 weeks
Exploratory: Length
Length/height [in cm]
Measured: 0 weeks
Exploratory: Length
Length/height [in cm]
Measured: 4 weeks
Exploratory: Length
Length/height [in cm]
Measured: 16 weeks
Exploratory: Length
Length/height [in cm]
Measured: 52 weeks
Exploratory: head circumference
head circumference (for children <2 years of age) [in cm]
Measured: 0 weeks
Exploratory: head circumference
head circumference (for children <2 years of age) [in cm]
Measured: 4 weeks
Exploratory: head circumference
head circumference (for children <2 years of age) [in cm]
Measured: 16 weeks
Exploratory: head circumference
head circumference (for children <2 years of age) [in cm]
Measured: 52 weeks
Exploratory: Biochemical markers of nutritional status
Macronutrient, micronutrient and mineral levels in blood [in a.o. mmol/L]
Measured: 0 weeks
Exploratory: Biochemical markers of nutritional status
Macronutrient, micronutrient and mineral levels in blood [in a.o. mmol/L]
Measured: 4 weeks
Exploratory: Biochemical markers of nutritional status
Macronutrient, micronutrient and mineral levels in blood [in a.o. mmol/L]
Measured: 16 weeks
Exploratory: Biochemical markers of nutritional status
Macronutrient, micronutrient and mineral levels in blood [in a.o. mmol/L]
Measured: 52 weeks
Exploratory: Gastrointestinal tolerance
GastrointestinaI symptoms [none/mild/moderate/severe]
Measured: 0 weeks
Exploratory: Gastrointestinal tolerance
GastrointestinaI symptoms [none/mild/moderate/severe]
Measured: 4 weeks
Exploratory: Gastrointestinal tolerance
GastrointestinaI symptoms [none/mild/moderate/severe]
Measured: 16 weeks
Exploratory: Gastrointestinal tolerance
GastrointestinaI symptoms [none/mild/moderate/severe]
Measured: 52 weeks
Exploratory: Stool frequency
number of stools per day
Measured: 0 weeks
Exploratory: Stool frequency
number of stools per day
Measured: 4 weeks
Exploratory: Stool frequency
number of stools per day
Measured: 16 weeks
Exploratory: Stool frequency
number of stools per day
Measured: 52 weeks
Exploratory: Stool consistency
parent reported stool consistency using stool scales (scale depending on diaper use or not) with categories within the range hard to watery
Measured: 0 weeks
Exploratory: Stool consistency
parent reported stool consistency using stool scales (scale depending on diaper use or not) with categories within the range hard to watery
Measured: 4 weeks
Exploratory: Stool consistency
parent reported stool consistency using stool scales (scale depending on diaper use or not) with categories within the range hard to watery
Measured: 16 weeks
Exploratory: Stool consistency
parent reported stool consistency using stool scales (scale depending on diaper use or not) with categories within the range hard to watery
Measured: 52 weeks
Exploratory: Nutrient intake
calculated energy, protein and micronutrient levels from parent diary [in a.o. mg/d]
Measured: 0 weeks
Exploratory: Nutrient intake
calculated energy, protein and micronutrient levels from parent diary [in a.o. mg/d]
Measured: 4 weeks
Exploratory: Nutrient intake
calculated energy, protein and micronutrient levels from parent diary [in a.o. mg/d]
Measured: 16 weeks
Exploratory: Nutrient intake
calculated energy, protein and micronutrient levels from parent diary [in a.o. mg/d]
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start1 Jul 2021
- Primary completion24 Jul 2023
- Study completion24 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Conditions, Including Impairment of the GI TractStudies of the same condition, open and under way.
- More trials run by Nutricia ResearchThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutricia Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265729
- Sponsor's protocol ID
- MPR18TA23134
- Acronym
- NICC
- Status last verified
- Oct 2026
- First submitted
- 28 Jan 2020
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Explorative, Post Launch Study of Neocate Amino Acid-based Feeds to Evaluate Nutritional Status and Gastrointestinal Tolerance in Infants and Children With Complex Conditions
- ClinicalTrials.gov ID
- NCT04265729
- Acronym / sponsor ID
- NICC / MPR18TA23134
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Nutricia ResearchIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 24 Jul 2023 (actual)
- Study completion
- 24 Jul 2023 (actual)
- First posted
- 12 Feb 2020 (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.
Infants and young children up to 10 years of age with a complex condition involving the gastrointestinal tract are at risk of poor nutritional status, including faltering growth. Due to the complex condition, standard nutrition is often not tolerated and causes gastrointestinal symptoms.
Formulas in which protein is replaced by its smallest elements, amino acids are easier for the body to digest and absorb. These formulas might be tolerated better and reduce gastrointestinal symptoms in infants and young children with complex conditions.
The objectives of the present, exploratory study are to gain clinical evidence related to the nutritional status and gastrointestinal tolerance in infants and young children with complex conditions receiving Neocate as their primary source of nutrition. Additional objectives are to describe the nutritional and pharmacological management of these infants and young children. Study duration for each participant will be 52 weeks at maximum.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single test product arm | Other | Dietary Supplement: Neocate Infant and Junior marketed productsuse of Neocate Infant and Junior marketed products (product type depending on subject's age and condition) |
Who may qualify
- Ages
- 0 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Infants and young children aged from 0 up to and including 10 years of age.
- Severe impairment of at least 1 organ system
- Impairment of the gastrointestinal tract, i.e. gastrointestinal disease, congenital abnormality, surgical resection, or gastrointestinal dysfunction (including symptoms of gastrointestinal dysmotility or malabsorption).
- Receiving at least 75% of their energy intake from Neocate (Neocate Infant or Junior powdered (marketed) product) at the time of study entry (V1).
- Expected to receive at least 75% of their energy intake from the study product for at least 4 weeks from study entry (V1).
Key exclusion criteria (8 listed)
- Infants born with a gestational age <37 weeks that are <40 weeks corrected age at the time of study entry (V1).
- Infants or children with endoscopically confirmed eosinophilic oesophagitis and prescribed an amino acid-based formula only for the management of the eosinophilic oesophagitis.
- Infants or children with a medical diagnosis that includes only (suspected) cow's milk allergy and/or multiple food allergy.
- Infants or children with renal dysfunction, e.g. acute or chronic kidney failure or kidney cancer.
- Infants or children with thyroid disorder or parathyroid disorder.
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 |
|---|---|---|
| Neocate Infant and Junior marketed productsuse of Neocate Infant and Junior marketed products | Dietary supplement | single test product arm |
Primary outcome
Exploratory: Weight
Time frame: 0 weeks
Weight [in g/kg]
Exploratory: Weight
Time frame: 4 weeks
Weight [in g/kg]
Exploratory: Weight
Time frame: 16 weeks
Weight [in g/kg]
Exploratory: Weight
Time frame: 52 weeks
Weight [in g/kg]
Exploratory: Length
Time frame: 0 weeks
Length/height [in cm]
Exploratory: Length
Time frame: 4 weeks
Length/height [in cm]
Exploratory: Length
Time frame: 16 weeks
Length/height [in cm]
Exploratory: Length
Time frame: 52 weeks
Length/height [in cm]
Exploratory: head circumference
Time frame: 0 weeks
head circumference (for children <2 years of age) [in cm]
Exploratory: head circumference
Time frame: 4 weeks
head circumference (for children <2 years of age) [in cm]
Exploratory: head circumference
Time frame: 16 weeks
head circumference (for children <2 years of age) [in cm]
Exploratory: head circumference
Time frame: 52 weeks
head circumference (for children <2 years of age) [in cm]
Exploratory: Biochemical markers of nutritional status
Time frame: 0 weeks
Macronutrient, micronutrient and mineral levels in blood [in a.o. mmol/L]
Exploratory: Biochemical markers of nutritional status
Time frame: 4 weeks
Macronutrient, micronutrient and mineral levels in blood [in a.o. mmol/L]
Exploratory: Biochemical markers of nutritional status
Time frame: 16 weeks
Macronutrient, micronutrient and mineral levels in blood [in a.o. mmol/L]
Exploratory: Biochemical markers of nutritional status
Time frame: 52 weeks
Macronutrient, micronutrient and mineral levels in blood [in a.o. mmol/L]
Exploratory: Gastrointestinal tolerance
Time frame: 0 weeks
GastrointestinaI symptoms [none/mild/moderate/severe]
Exploratory: Gastrointestinal tolerance
Time frame: 4 weeks
GastrointestinaI symptoms [none/mild/moderate/severe]
Exploratory: Gastrointestinal tolerance
Time frame: 16 weeks
GastrointestinaI symptoms [none/mild/moderate/severe]
Exploratory: Gastrointestinal tolerance
Time frame: 52 weeks
GastrointestinaI symptoms [none/mild/moderate/severe]
Exploratory: Stool frequency
Time frame: 0 weeks
number of stools per day
Exploratory: Stool frequency
Time frame: 4 weeks
number of stools per day
Exploratory: Stool frequency
Time frame: 16 weeks
number of stools per day
Exploratory: Stool frequency
Time frame: 52 weeks
number of stools per day
Exploratory: Stool consistency
Time frame: 0 weeks
parent reported stool consistency using stool scales (scale depending on diaper use or not) with categories within the range hard to watery
Exploratory: Stool consistency
Time frame: 4 weeks
parent reported stool consistency using stool scales (scale depending on diaper use or not) with categories within the range hard to watery
Exploratory: Stool consistency
Time frame: 16 weeks
parent reported stool consistency using stool scales (scale depending on diaper use or not) with categories within the range hard to watery
Exploratory: Stool consistency
Time frame: 52 weeks
parent reported stool consistency using stool scales (scale depending on diaper use or not) with categories within the range hard to watery
Exploratory: Nutrient intake
Time frame: 0 weeks
calculated energy, protein and micronutrient levels from parent diary [in a.o. mg/d]
Exploratory: Nutrient intake
Time frame: 4 weeks
calculated energy, protein and micronutrient levels from parent diary [in a.o. mg/d]
Exploratory: Nutrient intake
Time frame: 16 weeks
calculated energy, protein and micronutrient levels from parent diary [in a.o. mg/d]
Exploratory: Nutrient intake
Time frame: 52 weeks
calculated energy, protein and micronutrient levels from parent diary [in a.o. mg/d]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neocate Infant and Junior marketed products in people with Complex Conditions, Including Impairment of the GI Tract, run by Nutricia Research at 4 sites in 3 countries.
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Germany, United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exploratory: Weight (time frame: 0 weeks). The study lists 32 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2026.