Second Generation Human Milk Oligosaccharides Blend Study

NCT ID: NCT03722550

Last Updated: 2022-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 789 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-19
• Study Completion Date: 2022-01-19

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Control Group

Standard Starter Infant Formula, Standard Follow-up Formula, and Standard Growing-up Milk

Group Type: ACTIVE_COMPARATOR

Standard Starter Infant Formula, Follow-up Formula, and Growing-up Milk

Intervention Type: OTHER

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

Test Group 1

Starter 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

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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

Test Group 2

Starter 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

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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

Breastfed Group

Non-randomized Breastfed reference group

Group Type: ACTIVE_COMPARATOR

Breast-feeding

Intervention Type: OTHER

Exclusive Breast-feeding up to 4 months of age

Interventions

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

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

Intervention Type: OTHER

Breast-feeding

Exclusive Breast-feeding up to 4 months of age

Intervention Type: OTHER

Standard Starter Infant Formula, Follow-up Formula, and Growing-up Milk

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Infants whose parent(s)/Legally Acceptable Representative have reached the legal age of majority in the countries where the study is conducted.

3. Infants whose parent(s)/Legally Acceptable Representative are willing and able to comply with scheduled visits, and the requirements of the study protocol.

4. Infants whose parent(s)/Legally Acceptable Representative are able to be contacted directly by telephone throughout the study.

5. Infants whose parent(s)/Legally Acceptable Representative have a working freezer.

1. Healthy term (37-42 weeks of gestation) infant at birth.

2. At enrollment visit, post-natal age ≥ 7 days and ≤ 21 days (date of birth = day 0, 0.25 - 0.75 months old).

3. At enrollment, birth weight ≥ 2500g and ≤ 4500g.

4. 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.

5. 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.

Exclusion Criteria

1. Infants with conditions requiring infant feedings other than those specified in the protocol.

2. 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.

3. 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:

1. Evidence of major congenital malformations (e.g., cleft palate, extremity malformation).

2. Suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus, syphilis).

3. History of admission to the Neonatal Intensive Care Unit (NICU), with the exception of admission for jaundice phototherapy.

4. 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.

4. 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.

5. Currently participating or having participated in another clinical trial since birth

• Minimum Eligible Age: 7 Days
• Maximum Eligible Age: 21 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aleksander Krasnow, Lek. Med.

Role: PRINCIPAL_INVESTIGATOR

Gdańskie Centrum Zdrowia Sp. Z o.o.

Wiesław Olechowski, Dr n.med.

Role: PRINCIPAL_INVESTIGATOR

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

Sylwia Korzyńska, MD

Role: PRINCIPAL_INVESTIGATOR

Centrum Medyczne Pratia Ostrolęka

Anna Płoszczuk, Dr. n.med.

Role: PRINCIPAL_INVESTIGATOR

Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny Anna Płoszczuk

Magdalena Sidorowicz, Dr.

Role: PRINCIPAL_INVESTIGATOR

Centrum Medyczne Pratia Warszawa

Grażyna Jasieniak-Pinis, Lek. Med.

Role: PRINCIPAL_INVESTIGATOR

ATOPIA Niepubliczny Zakład Opieki Zdrowotnej Poradnie Specjalistyczne

Bartosz Korczowski, PhD MD Dr

Role: PRINCIPAL_INVESTIGATOR

Korczowski Bartosz Gabinet Lekarski

Piotr Korbal, Dr.

Role: PRINCIPAL_INVESTIGATOR

Szpital Uniwersytecki nr 2 Im. Dr Jana Biziela w Bydgoszczy Oddział Kliniczny Noworodków, Wcześniaków z Intensywną Terapią Noworodka wraz z

Marta Żołnowska, Lek. Med.

Role: PRINCIPAL_INVESTIGATOR

Centrum Medyczne Plejady

Bogusław Cimoszko, Lek. Med.

Role: PRINCIPAL_INVESTIGATOR

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

Wanda Furmaga-Jabłonska, Prof.

Role: PRINCIPAL_INVESTIGATOR

Uniwersytecki Szpital Dziecięcy w Lublinie

Marzena Nowak, Dr.

Role: PRINCIPAL_INVESTIGATOR

Centrum Medyczne PROMED

Georgios Marek Vasilopoulos, Dr.

Role: PRINCIPAL_INVESTIGATOR

Centrum Innowacyjnych Terapii Sp. z o.o.

Viktor Bauer, MD

Role: PRINCIPAL_INVESTIGATOR

Dr. Kenessey Albert Kórház-Rendelőintézet

Robert Simkó, MD

Role: PRINCIPAL_INVESTIGATOR

Futurenest Kft.

István Laki, MD

Role: PRINCIPAL_INVESTIGATOR

Kanizsai Dorottya Kórház

Éva Kovács, MD

Role: PRINCIPAL_INVESTIGATOR

Házi Gyermekorvosi Rendelő / Babadoki Kft.

Éva Szabó, MD

Role: PRINCIPAL_INVESTIGATOR

Csolnoky Ferenc Kórház

István Tokodi, MD

Role: PRINCIPAL_INVESTIGATOR

Mentaház Magánorvosi Központ Kft.

Zsuzsanna Tengelyi, MD

Role: PRINCIPAL_INVESTIGATOR

Clinexpert Kft.

Katalin Fister, MD

Role: PRINCIPAL_INVESTIGATOR

Clinexpert Gyöngyös Egészségügyi Szolgáltató Kft.

Anton Bilev, MD

Role: PRINCIPAL_INVESTIGATOR

MC ''Sveti Ivan Rilski - Chudotvorets''

Miroslava Bosheva, MD

Role: PRINCIPAL_INVESTIGATOR

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

Toni Grigorov, MD

Role: PRINCIPAL_INVESTIGATOR

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

Rositsa Karcheva-Beloeva, MD

Role: PRINCIPAL_INVESTIGATOR

Medical Center-1-Sevlievo

Margarita Koleva, MD

Role: PRINCIPAL_INVESTIGATOR

Diagnostic-consultative center Ritam TR

Stelyana Kraeva, MD

Role: PRINCIPAL_INVESTIGATOR

Alitera -Med-Medical Center

Olga Nikolova, MD

Role: PRINCIPAL_INVESTIGATOR

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

Tatyana Stoeva, MD

Role: PRINCIPAL_INVESTIGATOR

Medical Centre - Izgrev

Irina Popova, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital 'Deva Maria', Department for Naonatology

Svilen Dosev, MD

Role: PRINCIPAL_INVESTIGATOR

Multiprofile Hospital for Active treatment Ruse AD, Department of Paediatrics

Stefan Banov, MD

Role: PRINCIPAL_INVESTIGATOR

SMA Dr Stefan Banov

Sirma Dimitrova, MD

Role: PRINCIPAL_INVESTIGATOR

Medical Center Excelsior

Malgorzata Arciszewska, MD

Role: PRINCIPAL_INVESTIGATOR

Poliklinika Ginekolo.-Poloznicza

Locations

Sveti Ivan Rilski - Chudotvorets

Blagoevgrad, , Bulgaria

University Hospital Deva Maria, Department for Naonatology

Burgas, , Bulgaria

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

Kozloduy, , Bulgaria

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

Montana, , Bulgaria

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

Plovdiv, , Bulgaria

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

Rousse, , Bulgaria

Medical Center-1-Sevlievo EOOD

Sevlievo, , Bulgaria

1st Pediatric Consultative Clinic

Sofia, , Bulgaria

Medical Center Excelsior

Sofia, , Bulgaria

Medical Centre - Izgrev EOOD

Sofia, , Bulgaria

Alitera-Med-Medical Center EOOD

Sofia, , Bulgaria

Diagnostic-consultative center Ritam TR'' OOD

Stara Zagora, , Bulgaria

SMA Dr Stefan Banov

Stara Zagora, , Bulgaria

Dr. Kenessey Albert Kórház-Rendelőintézet Csecsemő és Gyermekosztály

Balassagyarmat, , Hungary

Clinexpert Kft.

Budapest, , Hungary

Clinexpert Gyöngyös Egészségügyi Szolgáltató Kft.

Gyöngyös, , Hungary

Futurenest Kft.

Miskolc, , Hungary

Kanizsai Dorottya Kórház Csecsemő és Gyermekgyógyászati Osztály

Nagykanizsa, , Hungary

Házi Gyermekorvosi Rendelő / Babadoki Kft.

Szeged, , Hungary

Mentaház Magánorvosi Központ Kft.

Székesfehérvár, , Hungary

Csolnoky Ferenc Kórház

Veszprém, , Hungary

Poliklinika Ginekolo.-Poloznicza

Bialystok, , Poland

Szpital Uniwersytecki nr 2

Bydgoszcz, , Poland

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

Gdansk, , Poland

Gdańskie Centrum Zdrowia Sp. Z o.o

Gdansk, , Poland

Centrum Medyczne Plejady

Krakow, , Poland

Grażyna Jasieniak-Pinis ATOPIA Niepubliczny Zakład Opieki Zdrowotnej Poradnie Specjalistyczne

Krakow, , Poland

Centrum Medyczne PROMED

Krakow, , Poland

Uniwersytecki Szpital Dziecięcy w Lublinie

Lublin, , Poland

Centrum Medyczne Pratia Ostrolęka

Ostrołęka, , Poland

Centrum Innowacyjnych Terapii Sp. z o.o.

Piaseczno, , Poland

Korczowski Bartosz Gabinet Lekarski

Rzeszów, , Poland

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

Tarnów, , Poland

Centrum Medyczne Pratia Warszawa

Warsaw, , Poland

Countries

Bulgaria; Hungary; Poland

References

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.

Reference Type: DERIVED

PMID: 35873420 (View on PubMed)

Other Identifiers

1624INF

Identifier Type: -

Identifier Source: org_study_id