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Healthy InfantsNCT03722550

Second Generation Human Milk Oligosaccharides Blend Study

A study testing Starter Infant Formula, Follow-up Formula, and Growing-up Milk Supplemented With a Blend of Five Human Milk Oligosaccharides, Breast-feeding and Standard Starter Infant Formula, Follow-up Formula, and Growing-up Milk in people with Healthy Infants, run by Société des Produits Nestlé (SPN) at 34 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The aim of this trial is to show that infants fed these new formulas, containing a blend of 5 Human Milk Oligosaccharides (HMOs), allow for growth in line with infants fed formulas without HMOs. There will be different groups in the trial: three formula-fed groups and a breastfed group. Read more about this study

Who is it for?
Ages 7 to 21 daysHealthy volunteers can take part
Conditions the study is for
Healthy Infants
What is being tested?
Starter Infant Formula, Follow-up Formula, and Growing-up Milk Supplemented With a Blend of Five Human Milk Oligosaccharides, Breast-feeding and Standard Starter Infant Formula, Follow-up Formula, and Growing-up Milk
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
789 participants
Where
34 sitesin 3 countries
Study dates
19 Sep 2018to 19 Jan 2022
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 to 21 days
  • 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)/Legally Acceptable Representative has been informed of all pertinent aspects of the study.
  • Infants whose parent(s)/Legally Acceptable Representative have reached the legal age of majority in the countries where the study is conducted.
  • Infants whose parent(s)/Legally Acceptable Representative are willing and able to comply with scheduled visits, and the requirements of the study protocol.
  • Infants whose parent(s)/Legally Acceptable Representative are able to be contacted directly by telephone throughout the study.
  • Infants whose parent(s)/Legally Acceptable Representative have a working freezer.
  • Infants must meet all of the following inclusion criteria to be eligible for enrollment into the study:
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  • Healthy term (37-42 weeks of gestation) infant at birth.
  • At enrollment visit, post-natal age ≥ 7 days and ≤ 21 days (date of birth = day 0, 0.25 - 0.75 months old).
  • At enrollment, birth weight ≥ 2500g and ≤ 4500g.
  • For formula-fed group, infants must be exclusively consuming and tolerating a cow's milk infant formula at time of enrollment and their parent(s)/Legally Acceptable Representative must have independently elected, before enrollment, not to breastfeed.
  • For breastfed group, infants must have been exclusively consuming breast milk since birth, and their parent(s)/Legally Acceptable Representative must have made the decision to continue exclusively breastfeeding until at least 4 month of age.

Who cannot join

  • Infants with conditions requiring infant feedings other than those specified in the protocol.
  • Infants receiving complementary foods or liquids defined as 4 or more teaspoons per day or approximately 20 g per day of complementary foods or liquids at or prior to enrollment.
  • Infants who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results, including:
  • Evidence of major congenital malformations (e.g., cleft palate, extremity malformation).
  • Suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus, syphilis).
  • History of admission to the Neonatal Intensive Care Unit (NICU), with the exception of admission for jaundice phototherapy.
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  • Other severe medical or laboratory abnormality (acute or chronic) which, in the judgment of the investigator, would make the infant inappropriate for entry into the study.
  • Infants who are presently receiving or have received prior to enrollment any of the following: medication(s) or supplement(s) which are known or suspected to affect the following: fat digestion, absorption, and/or metabolism (e.g., pancreatic enzymes); stool characteristics (e.g., glycerin suppositories, bismuth-containing medications, docusate, Maltsupex, or lactulose); growth (e.g. insulin or growth hormone); gastric acid secretion; or any study outcomes.
  • Currently participating or having participated in another clinical trial since birth

Trial locations and contacts

34 sites in 3 countries.

34 sites in 3 countries

Bulgaria13 sites

  • Sveti Ivan Rilski - Chudotvorets

    Blagoevgrad, 2700

  • University Hospital Deva Maria, Department for Naonatology

    Burgas, 8000

  • Multiprofile Hospital for Active Treatment Sveti Ivan Rilski Kozloduy,Department of Pediatrics

    Kozloduy, 3320

  • Multiprofile Hospital for Active Treatment City Clinic - Sveti Georgi EOOD,Department of Paediatrics

    Montana, 3400

  • University Multiorofile Hospital for active treatment Sveti Georgi EAD, Pediatric clinic

    Plovdiv, 4002

  • Multiprofile Hospital for Active treatment- Ruse AD, Department of Paediatrics

    Rousse, 7000

  • Medical Center-1-Sevlievo EOOD

    Sevlievo, 5400

  • 1st Pediatric Consultative Clinic

    Sofia, 1404

  • Medical Center Excelsior

    Sofia, 1407

  • Medical Centre - Izgrev EOOD

    Sofia, 1612

  • Alitera-Med-Medical Center EOOD

    Sofia, 1618

  • Diagnostic-consultative center Ritam TR'' OOD

    Stara Zagora, 6000

  • SMA Dr Stefan Banov

    Stara Zagora, 6000

Other trials in Bulgaria

Poland13 sites

  • Poliklinika Ginekolo.-Poloznicza

    Bialystok, 15-435

  • Szpital Uniwersytecki nr 2

    Bydgoszcz, 85-168

  • Clinical Vitae Sp z o.o. Poradnia Podstawowej Opieki Zdrowotnej

    Gdansk, 80-180

  • Gdańskie Centrum Zdrowia Sp. Z o.o

    Gdansk, 80-542

  • Centrum Medyczne Plejady

    Krakow, 30-363

  • Grażyna Jasieniak-Pinis ATOPIA Niepubliczny Zakład Opieki Zdrowotnej Poradnie Specjalistyczne

    Krakow, 31-159

  • Centrum Medyczne PROMED

    Krakow, 31-411

  • Uniwersytecki Szpital Dziecięcy w Lublinie

    Lublin, 20-093

  • Centrum Medyczne Pratia Ostrolęka

    Ostrołęka, 07-410

  • Centrum Innowacyjnych Terapii Sp. z o.o.

    Piaseczno, 05-500

  • Korczowski Bartosz Gabinet Lekarski

    Rzeszów, 35-302

  • ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. Z o.o

    Tarnów, 33-100

  • Centrum Medyczne Pratia Warszawa

    Warsaw, 01-868

Other trials in Poland

Hungary8 sites

  • Dr. Kenessey Albert Kórház-Rendelőintézet Csecsemő és Gyermekosztály

    Balassagyarmat, 2660

  • Clinexpert Kft.

    Budapest, 1033

  • Clinexpert Gyöngyös Egészségügyi Szolgáltató Kft.

    Gyöngyös, 3200

  • Futurenest Kft.

    Miskolc, 3527

  • Kanizsai Dorottya Kórház Csecsemő és Gyermekgyógyászati Osztály

    Nagykanizsa, 8800

  • Házi Gyermekorvosi Rendelő / Babadoki Kft.

    Szeged, 6723

  • Mentaház Magánorvosi Központ Kft.

    Székesfehérvár, 8000

  • Csolnoky Ferenc Kórház

    Veszprém, 8200

Other trials in Hungary

About this study

Official title: Growth, Safety and Efficacy of a Starter Infant Formula, Follow-up Formula, and Growing-up Milk Supplemented With a Blend of Five Human Milk Oligosaccharides: a Double-blind, Randomized, Controlled Trial

The aim of this trial is to show that infants fed these new formulas, containing a blend of 5 Human Milk Oligosaccharides (HMOs), allow for growth in line with infants fed formulas without HMOs.

There will be different groups in the trial: three formula-fed groups and a breastfed group.

Read the detailed description

These 5 HMOs are identical to the ones found naturally in human milk. They are natural prebiotics (or complex sugars) with potential health benefits. Prebiotics are natural compounds that help the establishment of beneficial gut bacteria (such as bifidobacteria), while preventing bad bacteria from doing harm. Supplementing diets with certain prebiotics has been shown to be well tolerated in adults and infants and to provide potential benefits.Therefore, the trial also aims to understand if consuming HMOs supplemented formulas could strengthen immunity and prevent common illnesses (for example, respiratory illnesses) in infants and toddlers. Furthermore, stool frequency and consistency will be monitored, so as to evaluate digestive tolerance to the formula.

Conditions
Healthy Infants
Being tested
Starter Infant Formula, Follow-up Formula, and Growing-up Milk Supplemented With a Blend of Five Human Milk Oligosaccharides, Breast-feeding, Standard Starter Infant Formula, Follow-up Formula, and Growing-up Milk

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Starter Infant Formula, Follow-up Formula, and Growing-up Milk Supplemented With a Blend of Five Human Milk OligosaccharidesOther

    Study formulas are administered orally, ad libitum, from enrollment until 15 months of age

  • Breast-feedingOther

    Exclusive Breast-feeding up to 4 months of age

  • Standard Starter Infant Formula, Follow-up Formula, and Growing-up MilkOther

    Standard Study formulas are administered orally, ad libitum, from enrollment until 15 months of age

Study groups in NCT03722550
Study groupRoleWhat they receive
Control GroupActive comparatorStandard Starter Infant Formula, Standard Follow-up Formula, and Standard Growing-up Milk
Receives: Other: Standard Starter Infant Formula, Follow-up Formula, and Growing-up Milk
Test Group 1ExperimentalStarter Infant Formula (same as Control Group) supplemented with 1.5g/L of Human Milk Oligosaccharides, Follow-up Formula (same as Control Group) supplemented with 0.5g/L of Human Milk Oligosaccharides, and Growing-up Milk (same as Control Group) supplemented with 0.4g/L of Human Milk Oligosaccharides
Receives: Other: Starter Infant Formula, Follow-up Formula, and Growing-up Milk Supplemented With a Blend of Five Human Milk Oligosaccharides
Test Group 2ExperimentalStarter Infant Formula (same as Control Group) supplemented with 2.5g/L of Human Milk Oligosaccharides, Follow-up Formula (same as Control Group) supplemented with 0.5g/L of Human Milk Oligosaccharides, and Growing-up Milk (same as Control Group) supplemented with 0.4g/L of Human Milk Oligosaccharides
Receives: Other: Starter Infant Formula, Follow-up Formula, and Growing-up Milk Supplemented With a Blend of Five Human Milk Oligosaccharides
Breastfed GroupActive comparatorNon-randomized Breastfed reference group
Receives: Other: Breast-feeding

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To compare the growth of infants between the groups

    To compare the growth (weight gain, g/day) of infants randomized to Test Groups (TG1 or TG2) versus Control Group (CG)

    Measured: From Study Day 1 to 4 months of age

  2. To compare recurrent incidences of illness of infants between the groups

    To compare recurrent incidences of illness (specifically lower and upper respiratory tract illnesses including bronchitis/bronchiolitis), of infants randomized to Test Groups (TG1 or TG2) versus Control Group (CG)

    Measured: From Study Day 1 to 15 months of age

Secondary outcomes (22)

  1. Infant illness and infection outcomes

    Specific parent-reported infant illness symptoms and physician confirmed diagnoses of lower respiratory tract infection (LRTI), upper respiratory tract infection (URTI), total respiratory tract infection (TRTI), gastrointestinal infection (GII), ear illness [including: otitis media (OM), ear infection, ear inflammation, and ear pain], and fever will be combined to report infant illness and infection outcomes (Episode, incidence, duration, severity, and recurrence)

    Measured: at different stages of feeding 1st age Infant Formula, 2nd age Follow-up Formula, and 3rd age Growing-up Milk when applicable

  2. Medication use (specifically antimicrobials and antipyretics)

    Medication type and duration of intake will be combined to report the medication use

    Measured: From enrollment until 15 months of age

  3. Absenteeism: Time away from daycare (infant) or work (parent)

    Time away from daycare (infant) or work (parent)

    Measured: From enrollment until 15 months of age

  4. Fecal microbiome composition, diversity, community type

    Fecal microbiota composition, diversity, and microbiota community type will be assessed using cutting-edge next generation sequencing technology and combined to report the Fecal microbiome

    Measured: Stool sample collected at infant age less than 0.75, 3, 6, 12, and 15 months of age (a subset of 105 infants per formula group; 90 breastfed infants)

  5. Fecal metabolic profile

    Measures of fecal metabolism will be combined to report fecal metabolic profile (fecal pH, fecal organic acids, as well as additional targeted/untargeted metabolomics and cell-based functional assays)

    Measured: Stool sample collected at infant age less than 0.75, 3, 6, 12, and 15 months of age (a subset of 105 infants per formula group; 90 breastfed infants)

  6. Markers of immune and gut health

    Fecal markers of immune and gut health will include secretory immunoglobulin A IgA [total], alpha-1 antitrypsin, and calprotectin.

    Measured: Stool sample collected at infant age less than 0.75, 3, 6, 12, and 15 months of age (a subset of 105 infants per formula group; 90 breastfed infants)

  7. Blood Markers of immune health

    Plasma and peripheral blood mononuclear cells, Extracellular in vivo and ex vivo circulating cytokine levels will be measured in plasma

    Measured: At 6 months of age

  8. Gastrointestinal tolerance

    Stool patterns (stool frequency and consistency), Gastrointestinal symptoms, Gastrointestinal-related behaviors, and milk intake will be combined to report the gastrointestinal tolerance

    Measured: Stool sample collected at infant age less than 0.75, 3, 6, 12, and 15 months of age (a subset of 105 infants per formula group; 90 breastfed infants)

  9. Cognitive and behavioral outcomes

    Assessment at 15 months through the use of the MacArthur-Bates Communicative Development Inventories (MCDI) and the Early Childhood Behavior Questionnaire (ECBQ), two parent-reported questionnaires that evaluate early language/vocabulary and development of communication skills, that will be combined to report the cognitive and behavioral outcomes

    Measured: At 15 months of age

  10. DNA Genotyping of fucosyltransferase 2 and 3 (secretor status)

    Association between secretor status and illnesses/infections via microbiome modulation will be evaluated.

    Measured: At Study Day 60 +/- 5 days

  11. Breastmilk collection for Human Milk Oligosaccharides profile analysis (breastfeeding mothers only)

    A small sample of milk (1ml) will be hand pumped, collected in an Eppendorf tube and stored frozen

    Measured: At Study Day 90 +/- 5 days

  12. Anthropometric measurements: Weight

    Weight measurements in grams to report anthropometric measurements.

    Measured: From enrollment until 15 months of age

  13. Anthropometric measurements: Length

    Length measurements in centimeters to report anthropometric measurements.

    Measured: From enrollment until 15 months of age

  14. Anthropometric measurements: Head circumference

    Head circumference measurements in centimeters to report anthropometric measurements.

    Measured: From enrollment until 15 months of age

  15. Anthropometric measurements: BMI

    BMI measurements in kg/m^2 to report anthropometric measurements.

    Measured: From enrollment until 15 months of age

  16. Anthropometric measurements: World Health Organization (WHO) growth standard calculated z-scores

    WHO growth standard z-scores including weight-for-age, length-for-age, weight-for-length, head-circumference-for-age, BMI-for-age and weight velocity will be calculated and combined to report anthropometric measurements.

    Measured: From enrollment until 15 months of age

  17. Vital signs: Infant respiration

    Infant respiration in breaths per minute will also be measured to report vital signs

    Measured: From enrollment until 15 months of age

  18. Vital signs: Heart rate

    Heart rate in beasts per minute will also be measured to report vital signs

    Measured: From enrollment until 15 months of age

  19. Vital signs: Body temperature

    Body temperature in Celsius degree will also be measured to report vital signs

    Measured: From enrollment until 15 months of age

  20. 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 21 days or 0.75 months through the 2 weeks post-study telephone contact at infant age 464 days

  21. Bone index measurement

    Bone index measurement will be conducted using a non-invasive and radiation-free ultra-sound sonometer measuring bone transmission time and speed of sound at the radius and tibia site, including also the measurement of the femur and radius length

    Measured: From enrollment until 15 months of age

  22. Dietary pattern

    Dietary pattern will be evaluated using a Food frequency questionnaire including sixteen key food groups for infants and young children

    Measured: From 6 months of age until 15 months of age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2018
  2. Study start19 Sep 2018
  3. Primary completion5 Nov 2021
  4. Study completion19 Jan 2022

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
789 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03722550
Sponsor's protocol ID
1624INF
Status last verified
Feb 2022
First submitted
27 Sep 2018
Last updated
17 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bosheva M, Tokodi I, Krasnow A, Pedersen HK, Lukjancenko O, Eklund AC, Grathwohl D, Sprenger N, Berger B, Cercamondi CI; 5 HMO Study Investigator Consortium. Infant Formula With a Specific Blend of Five Human Milk Oligosaccharides Drives the Gut Microbiota Development and Improves Gut Maturation Markers: A Randomized Controlled Trial. Front Nutr. 2022 Jul 6;9:920362. doi: 10.3389/fnut.2022.920362. eCollection 2022.

    PubMed 35873420

Questions about this trial

What is this clinical trial studying?

A study testing Starter Infant Formula, Follow-up Formula, and Growing-up Milk Supplemented With a Blend of Five Human Milk Oligosaccharides, Breast-feeding and Standard Starter Infant Formula, Follow-up Formula, and Growing-up Milk in people with Healthy Infants, run by Société des Produits Nestlé (SPN) at 34 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 11 inclusion and 9 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 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in Bulgaria, Poland, Hungary. 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?

To compare the growth of infants between the groups (time frame: From Study Day 1 to 4 months of age). 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 NCT03722550, 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 17 Feb 2022.

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