GrowthNEHMONCT04055363
Human Milk Oligosaccharides (HMOs) Post-market Study on Infants
A study testing HMO-supplemented infant formula in people with Growth and Tolerance, run by Société des Produits Nestlé (SPN) at 6 sites in Spain.
Trial summary
Human milk oligosaccharides (HMOs) represent the third largest solid component of breast milk. Technology advancements made it possible to supplement infant formulas with HMOs (2'FL, LNnT). Read more about this study
- Who is it for?
- Ages 7 days to 2 monthsHealthy volunteers can take part
- Conditions the study is for
- Growth, Tolerance, Adverse Event
- What is being tested?
- HMO-supplemented infant formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 6 sitesSpain
- Study dates
- 1 Oct 2018to 31 Dec 2018
- 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 7 days to 2 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Evidence of personally signed and dated informed consent document indicating that the infant's parent(s) have been informed of all pertinent aspects of the study
- Parent(s) are willing and able to fulfill the requirements of the study protocol
- Healthy full term (37-42 weeks gestation) infant
- Be between post-natal age (Date of Birth = Day 0) 7 days to 2 months
- Parent(s) must have independently elected, before enrollment, to formula feed
Who cannot join
- Evidence of personally signed and dated informed consent document indicating that the infant's parent(s) have been informed of all pertinent aspects of the study
- Parent(s) are willing and able to fulfill the requirements of the study protocol
- Healthy full term (37-42 weeks gestation) infant
- Be between post-natal age (Date of Birth = Day 0) 7 days to 2 months
- Infants must have been exclusively consuming breast milk since birth, and their parent(s) must have made the decision to continue exclusively breastfeeding until at least 4 month of age
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites
Hospital Maternal MH Belén
A Coruña, Galicia, 15011
Universitary Hospital Quirón-Dexeus
Barcelona, 08028
Vitha Santa Catalina Hospital
Las Palmas de Gran Canaria, Canary Islands, 35005
Ruber Internacional Clinic
Madrid, 28034
Hispalense Group
Seville
Casa de la Salud, Hospital
Valencia, 46021
About this study
Official title: Growth and Feeding Tolerance of Infants Consuming a Formula Supplemented With Human Milk Oligosaccharides (HMOs): An Uncontrolled, Open-label, Prospective Study
Human milk oligosaccharides (HMOs) represent the third largest solid component of breast milk. Technology advancements made it possible to supplement infant formulas with HMOs (2'FL, LNnT). Two published RCTs have demonstrated that infant formulas supplemented with 2'FL or 2'FL+LNnT are safe, well-tolerated, support normal grow, and may support healthy GI function and confer immune benefits. The performance of HMOs-supplemented formulas assessed in a real-world setting is complementary to previously conducted RCTs conducted in highly controlled clinical settings. Main objectives will be to monitor the safety \& tolerance of HMOs-supplemented formulas in larger and diverse infant populations; to assess the performance of HMOs-supplemented formulas in mixed-fed infants, a population that was not studied in previous RCTs but likely represents a relatively common feeding regimen. Finally, considering the potential health/immune benefits of HMOs, it is also important explore the incidences of illnesses (i.e., respiratory illnesses, GI illnesses, and fever) associated with consuming HMOs-supplemented formulas and compare with breastfed infants data.
Read the detailed description
Objectives:
The main objective of this study is to document the growth and feeding tolerance of healthy term infants consuming an infant formula supplemented with HMOs for 8 weeks (56 days), in a real-world setting.
Main endpoints:
- Growth documented via monitoring the anthropometric parameters including weight, length, head circumference, BMI and their corresponding z-scores (i.e., z-scores for weight-for-age, length-for-age, weight-for-length, head circumference-for-age, and BMI-for-age) calculated using the 2006 WHO Growth Standards
- Feeding tolerance assessed via monitoring parent-reported overall GI symptom burden measured by the Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score (13-item summary score)
Additional objectives:
To describe the following outcomes in infants fed an infant formula supplemented with HMOs:
- Formula acceptability
- Despite there are no expected safety concerns, standard Adverse Events (AEs) monitoring will be implemented during the study
Additional endpoints:
- Formula acceptability assessed by the Study Formula Satisfaction Questionnaire
- Reported AEs and Serious Adverse Events (SAEs) including type, incidence, severity, seriousness and relation to study formula consumption as well as concomitant medications and non-pharmacological treatments.
- Select morbidities of interest (i.e., respiratory illnesses, GI illnesses, and fever) will be collected as part of AE reporting and specific corresponding AE guidance forms will be used to standardize reporting of such AEs
Trial design:
Uncontrolled, single arm, open-label, prospective study in infants (enrolled at postnatal age 7 days to 2 months) fed the study formula for 8 weeks (56 days)
A group of exclusively breastfed infants (BF) will serve as a reference group in parallel to the study arm. For the BF group, Infants must have been exclusively consuming breast milk since birth, and their parent(s) must have made the decision to continue exclusively breastfeeding until at least 4 month of age
Trial population:
Healthy, male and female, term infants, 7 days postnatal age to 2 months of age at the enrollment
Treatment duration:
Total study participation/intervention up to approximately 8 weeks
- Conditions
- Growth, Tolerance, Adverse Event, Disorder of Intestine, Disorder Lung
- Being tested
- HMO-supplemented infant formula
- Keywords
- Growth, Tolerance, Adverse Event, Gastrointestinal disorder, Respiratory infection, Gastrointestinal infection
- Medical subject headings
- Intestinal Diseases, Lung Diseases, Gastrointestinal Diseases, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMO-supplemented infant formulaOther
Starter Infant Formula supplemented with 1.5g/L of Human Milk Oligosaccharides
| Study group | Role | What they receive |
|---|---|---|
| Formula-fed infants | Experimental | Infants fed exclusively with experimental formula Receives: Other: HMO-supplemented infant formula |
| Mixed-fed infants | Experimental | Infants receiving breastmilk and experimental formula Receives: Other: HMO-supplemented infant formula |
| Breast-fed infants | No intervention | Reference group of exclusively breastfed |
What is being measured
The primary outcome is the main question the study is designed to answer.
World Health Organization (WHO) based weight-for-age z-scores
Weight-for-age z-scores using WHO growth standards
Measured: 8 weeks (study end)
World Health Organization (WHO) based length-for-age z-scores
Length-for-age z-scores using WHO growth standards
Measured: 8 weeks (study end)
World Health Organization (WHO) weight-for-length z-scores
Weight-for-length z-scores using WHO growth standards
Measured: 8 weeks (study end)
World Health Organization (WHO) head-circumference-for-age z-scores
head-circumference-for-age z-scores using WHO growth standards
Measured: 8 weeks (study end)
World Health Organization (WHO) based body-mass-index (BMI)-for-age z-scores
Weight and height will be combined to calculate BMI in kg/m^2, then BMI-for-age z-scores will be derived using WHO growth standards
Measured: 8 weeks (study end)
Feeding tolerance
The Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score will be used to assess GI distress. This is a validated 13-item questionnaire where each item is scored on a scale of 1 to 5 with higher values indicating greater GI distress. A composite IGSQ score is derived from summing the individual scores with a possible range of 13 to 65 where higher values indicate greater GI distress and values ≤23 indicate no digestive distress.
Measured: 4 weeks (study midpoint)
Feeding tolerance
The Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score will be used to assess GI distress. This is a validated 13-item questionnaire where each item is scored on a scale of 1 to 5 with higher values indicating greater GI distress. A composite IGSQ score is derived from summing the individual scores with a possible range of 13 to 65 where higher values indicate greater GI distress and values ≤23 indicate no digestive distress.
Measured: 8 weeks (study end)
Secondary outcomes (6)
Formula acceptability
Study Formula Satisfaction Questionnaire
Measured: 4 weeks (study midpoint), 8 weeks (study end)
Standard adverse events (AEs) reporting for safety assessment
Reported adverse events (AEs) and Serious Adverse Events (SAEs) include type, incidence, severity, seriousness and relation to feeding
Measured: From the time the informed consent form has been signed at enrollment infant age less than 7 days to 2 months through the 8 weeks of intervention
Weight
Weight measurements in grams
Measured: 8 weeks (study end)
Length
Length measurements in centimeters
Measured: 8 weeks (study end)
Head circumference
Head circumference measurements in centimeters
Measured: 8 weeks (study end)
Body-mass-index (BMI)
Weight and height will be combined to report BMI in kg/m^2
Measured: 8 weeks (study end)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start1 Oct 2018
- Primary completion30 Nov 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GrowthStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Puerta de Hierro University Hospital, University of Navarrra Hospital (Clinica Universitaria), Grupo Pulso, Casa de la Salud Hospital, Vitha Santa Catalina Hospital, Quirón-Dexeus Universitary Hospital, Hospital Ruber Internacional, Grupo Hispalense de Pediatría Hospital, MH Belén Maternal Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04055363
- Sponsor's protocol ID
- 1806INF - Spain
- Acronym
- NEHMO
- Status last verified
- Aug 2019
- First submitted
- 11 Jul 2019
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Storm HM, Shepard J, Czerkies LM, Kineman B, Cohen SS, Reichert H, Carvalho R. 2'-Fucosyllactose Is Well Tolerated in a 100% Whey, Partially Hydrolyzed Infant Formula With Bifidobacterium lactis: A Randomized Controlled Trial. Glob Pediatr Health. 2019 Mar 15;6:2333794X19833995. doi: 10.1177/2333794X19833995. eCollection 2019.
PubMed 30906817
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth and Feeding Tolerance of Infants Consuming a Formula Supplemented With Human Milk Oligosaccharides (HMOs): An Uncontrolled, Open-label, Prospective Study
- ClinicalTrials.gov ID
- NCT04055363
- Acronym / sponsor ID
- NEHMO / 1806INF - Spain
- Conditions
- Growth, Tolerance, Adverse Event, Disorder of Intestine, Disorder Lung
- Keywords
- Growth, Tolerance, Adverse Event, Gastrointestinal disorder, Respiratory infection, Gastrointestinal infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Collaborators
- Puerta de Hierro University Hospital, University of Navarrra Hospital (Clinica Universitaria), Grupo Pulso, Casa de la Salud Hospital, Vitha Santa Catalina Hospital, Quirón-Dexeus Universitary Hospital, Hospital Ruber Internacional, Grupo Hispalense de Pediatría Hospital, MH Belén Maternal Hospital
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 13 Aug 2019 (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.
Human milk oligosaccharides (HMOs) represent the third largest solid component of breast milk. Technology advancements made it possible to supplement infant formulas with HMOs (2'FL, LNnT). Two published RCTs have demonstrated that infant formulas supplemented with 2'FL or 2'FL+LNnT are safe, well-tolerated, support normal grow, and may support healthy GI function and confer immune benefits. The performance of HMOs-supplemented formulas assessed in a real-world setting is complementary to previously conducted RCTs conducted in highly controlled clinical settings. Main objectives will be to monitor the safety \& tolerance of HMOs-supplemented formulas in larger and diverse infant populations; to assess the performance of HMOs-supplemented formulas in mixed-fed infants, a population that was not studied in previous RCTs but likely represents a relatively common feeding regimen. Finally, considering the potential health/immune benefits of HMOs, it is also important explore the incidences of illnesses (i.e., respiratory illnesses, GI illnesses, and fever) associated with consuming HMOs-supplemented formulas and compare with breastfed infants data.
Detailed description
Objectives:
The main objective of this study is to document the growth and feeding tolerance of healthy term infants consuming an infant formula supplemented with HMOs for 8 weeks (56 days), in a real-world setting.
Main endpoints:
- Growth documented via monitoring the anthropometric parameters including weight, length, head circumference, BMI and their corresponding z-scores (i.e., z-scores for weight-for-age, length-for-age, weight-for-length, head circumference-for-age, and BMI-for-age) calculated using the 2006 WHO Growth Standards
- Feeding tolerance assessed via monitoring parent-reported overall GI symptom burden measured by the Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score (13-item summary score)
Additional objectives:
To describe the following outcomes in infants fed an infant formula supplemented with HMOs:
- Formula acceptability
- Despite there are no expected safety concerns, standard Adverse Events (AEs) monitoring will be implemented during the study
Additional endpoints:
- Formula acceptability assessed by the Study Formula Satisfaction Questionnaire
- Reported AEs and Serious Adverse Events (SAEs) including type, incidence, severity, seriousness and relation to study formula consumption as well as concomitant medications and non-pharmacological treatments.
- Select morbidities of interest (i.e., respiratory illnesses, GI illnesses, and fever) will be collected as part of AE reporting and specific corresponding AE guidance forms will be used to standardize reporting of such AEs
Trial design:
Uncontrolled, single arm, open-label, prospective study in infants (enrolled at postnatal age 7 days to 2 months) fed the study formula for 8 weeks (56 days)
A group of exclusively breastfed infants (BF) will serve as a reference group in parallel to the study arm. For the BF group, Infants must have been exclusively consuming breast milk since birth, and their parent(s) must have made the decision to continue exclusively breastfeeding until at least 4 month of age
Trial population:
Healthy, male and female, term infants, 7 days postnatal age to 2 months of age at the enrollment
Treatment duration:
Total study participation/intervention up to approximately 8 weeks
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Formula-fed infants | Experimental | Other: HMO-supplemented infant formulaInfants fed exclusively with experimental formula |
| Mixed-fed infants | Experimental | Other: HMO-supplemented infant formulaInfants receiving breastmilk and experimental formula |
| Breast-fed infants | No intervention | –Reference group of exclusively breastfed |
Who may qualify
- Ages
- 7 days to 2 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Evidence of personally signed and dated informed consent document indicating that the infant's parent(s) have been informed of all pertinent aspects of the study
- Parent(s) are willing and able to fulfill the requirements of the study protocol
- Healthy full term (37-42 weeks gestation) infant
- Be between post-natal age (Date of Birth = Day 0) 7 days to 2 months
- Parent(s) must have independently elected, before enrollment, to formula feed
Key exclusion criteria (5 listed)
- Evidence of personally signed and dated informed consent document indicating that the infant's parent(s) have been informed of all pertinent aspects of the study
- Parent(s) are willing and able to fulfill the requirements of the study protocol
- Healthy full term (37-42 weeks gestation) infant
- Be between post-natal age (Date of Birth = Day 0) 7 days to 2 months
- Infants must have been exclusively consuming breast milk since birth, and their parent(s) must have made the decision to continue exclusively breastfeeding until at least 4 month of age
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 |
|---|---|---|
| HMO-supplemented infant formulaStarter Infant Formula supplemented with 1.5g/L of Human Milk Oligosaccharides | Other | Formula-fed infants, Mixed-fed infants |
Primary outcome
World Health Organization (WHO) based weight-for-age z-scores
Time frame: 8 weeks (study end)
Weight-for-age z-scores using WHO growth standards
World Health Organization (WHO) based length-for-age z-scores
Time frame: 8 weeks (study end)
Length-for-age z-scores using WHO growth standards
World Health Organization (WHO) weight-for-length z-scores
Time frame: 8 weeks (study end)
Weight-for-length z-scores using WHO growth standards
World Health Organization (WHO) head-circumference-for-age z-scores
Time frame: 8 weeks (study end)
head-circumference-for-age z-scores using WHO growth standards
World Health Organization (WHO) based body-mass-index (BMI)-for-age z-scores
Time frame: 8 weeks (study end)
Weight and height will be combined to calculate BMI in kg/m^2, then BMI-for-age z-scores will be derived using WHO growth standards
Feeding tolerance
Time frame: 4 weeks (study midpoint)
The Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score will be used to assess GI distress. This is a validated 13-item questionnaire where each item is scored on a scale of 1 to 5 with higher values indicating greater GI distress. A composite IGSQ score is derived from summing the individual scores with a possible range of 13 to 65 where higher values indicate greater GI distress and values ≤23 indicate no digestive distress.
Feeding tolerance
Time frame: 8 weeks (study end)
The Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score will be used to assess GI distress. This is a validated 13-item questionnaire where each item is scored on a scale of 1 to 5 with higher values indicating greater GI distress. A composite IGSQ score is derived from summing the individual scores with a possible range of 13 to 65 where higher values indicate greater GI distress and values ≤23 indicate no digestive distress.
6 secondary outcomes
Formula acceptability
Time frame: 4 weeks (study midpoint), 8 weeks (study end)
Standard adverse events (AEs) reporting for safety assessment
Time frame: From the time the informed consent form has been signed at enrollment infant age less than 7 days to 2 months through the 8 weeks of intervention
Weight
Time frame: 8 weeks (study end)
Length
Time frame: 8 weeks (study end)
Head circumference
Time frame: 8 weeks (study end)
Body-mass-index (BMI)
Time frame: 8 weeks (study end)
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 13 Aug 2019.
- Background: PubMed 30906817Storm HM, Shepard J, Czerkies LM, Kineman B, Cohen SS, Reichert H, Carvalho R. 2'-Fucosyllactose Is Well Tolerated in a 100% Whey, Partially Hydrolyzed Infant Formula With Bifidobacterium lactis: A Randomized Controlled Trial. Glob Pediatr Health. 2019 Mar 15;6:2333794X19833995. doi: 10.1177/2333794X19833995. eCollection 2019.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HMO-supplemented infant formula in people with Growth and Tolerance, run by Société des Produits Nestlé (SPN) at 6 sites in Spain.
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 5 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 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain. 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?
World Health Organization (WHO) based weight-for-age z-scores (time frame: 8 weeks (study end)). The study lists 7 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 NCT04055363, which also lists 1 linked publication.
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 13 Aug 2019.