Second Generation Human Milk Oligosaccharides Blend Study

NCT03722550 | Completed

• 1 other identifier: 1624INF
• Study Type: interventional
• Target: 789
• Locations: 3 countries
• Sites: 34

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.

Conditions

Healthy Infants

Outcome Measures

Primary Outcomes (2)

• 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)

  From Study Day 1 to 4 months of age

• 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)

  From Study Day 1 to 15 months of age

Secondary Outcomes (22)

• Infant illness and infection outcomes

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

• Medication use (specifically antimicrobials and antipyretics)

  From enrollment until 15 months of age

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

  From enrollment until 15 months of age

• Fecal microbiome composition, diversity, community type

  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)

• Fecal metabolic profile

  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)

Study Arms (4)

Control Group

ACTIVE COMPARATOR

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

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

Test Group 1

EXPERIMENTAL

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

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

Test Group 2

EXPERIMENTAL

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

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

Breastfed Group

ACTIVE COMPARATOR

Non-randomized Breastfed reference group

Other: Breast-feeding

Interventions

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

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

Test Group 1; Test Group 2

Breast-feeding OTHER

Exclusive Breast-feeding up to 4 months of age

Breastfed Group

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

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

Control Group

Eligibility Criteria

• Age: 7 Days - 21 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (34)

Sveti Ivan Rilski - Chudotvorets

Blagoevgrad, 2700, Bulgaria

Location

University Hospital Deva Maria, Department for Naonatology

Burgas, 8000, Bulgaria

Location

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

Kozloduy, 3320, Bulgaria

Location

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

Montana, 3400, Bulgaria

Location

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

Plovdiv, 4002, Bulgaria

Location

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

Rousse, 7000, Bulgaria

Location

Medical Center-1-Sevlievo EOOD

Sevlievo, 5400, Bulgaria

Location

1st Pediatric Consultative Clinic

Sofia, 1404, Bulgaria

Location

Medical Center Excelsior

Sofia, 1407, Bulgaria

Location

Medical Centre - Izgrev EOOD

Sofia, 1612, Bulgaria

Location

Alitera-Med-Medical Center EOOD

Sofia, 1618, Bulgaria

Location

Diagnostic-consultative center Ritam TR'' OOD

Stara Zagora, 6000, Bulgaria

Location

SMA Dr Stefan Banov

Stara Zagora, 6000, Bulgaria

Location

Dr. Kenessey Albert Kórház-Rendelőintézet Csecsemő és Gyermekosztály

Balassagyarmat, 2660, Hungary

Location

Clinexpert Kft.

Budapest, 1033, Hungary

Location

Clinexpert Gyöngyös Egészségügyi Szolgáltató Kft.

Gyöngyös, 3200, Hungary

Location

Futurenest Kft.

Miskolc, 3527, Hungary

Location

Kanizsai Dorottya Kórház Csecsemő és Gyermekgyógyászati Osztály

Nagykanizsa, 8800, Hungary

Location

Házi Gyermekorvosi Rendelő / Babadoki Kft.

Szeged, 6723, Hungary

Location

Mentaház Magánorvosi Központ Kft.

Székesfehérvár, 8000, Hungary

Location

Csolnoky Ferenc Kórház

Veszprém, 8200, Hungary

Location

Poliklinika Ginekolo.-Poloznicza

Bialystok, 15-435, Poland

Location

Szpital Uniwersytecki nr 2

Bydgoszcz, 85-168, Poland

Location

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

Gdansk, 80-180, Poland

Location

Gdańskie Centrum Zdrowia Sp. Z o.o

Gdansk, 80-542, Poland

Location

Centrum Medyczne Plejady

Krakow, 30-363, Poland

Location

Grażyna Jasieniak-Pinis ATOPIA Niepubliczny Zakład Opieki Zdrowotnej Poradnie Specjalistyczne

Krakow, 31-159, Poland

Location

Centrum Medyczne PROMED

Krakow, 31-411, Poland

Location

Uniwersytecki Szpital Dziecięcy w Lublinie

Lublin, 20-093, Poland

Location

Centrum Medyczne Pratia Ostrolęka

Ostrołęka, 07-410, Poland

Location

Centrum Innowacyjnych Terapii Sp. z o.o.

Piaseczno, 05-500, Poland

Location

Korczowski Bartosz Gabinet Lekarski

Rzeszów, 35-302, Poland

Location

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

Tarnów, 33-100, Poland

Location

Centrum Medyczne Pratia Warszawa

Warsaw, 01-868, Poland

Location

Related Publications (1)

• 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.

  PMID: 35873420 DERIVED

MeSH Terms

Interventions

Lactation

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Postpartum Period

Study Officials

• Aleksander Krasnow, Lek. Med.

  Gdańskie Centrum Zdrowia Sp. Z o.o.

  PRINCIPAL INVESTIGATOR

• Wiesław Olechowski, Dr n.med.

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

  PRINCIPAL INVESTIGATOR

• Sylwia Korzyńska, MD

  Centrum Medyczne Pratia Ostrolęka

  PRINCIPAL INVESTIGATOR

• Anna Płoszczuk, Dr. n.med.

  Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny Anna Płoszczuk

  PRINCIPAL INVESTIGATOR

• Magdalena Sidorowicz, Dr.

  Centrum Medyczne Pratia Warszawa

  PRINCIPAL INVESTIGATOR

• Grażyna Jasieniak-Pinis, Lek. Med.

  ATOPIA Niepubliczny Zakład Opieki Zdrowotnej Poradnie Specjalistyczne

  PRINCIPAL INVESTIGATOR

• Bartosz Korczowski, PhD MD Dr

  Korczowski Bartosz Gabinet Lekarski

  PRINCIPAL INVESTIGATOR

• Piotr Korbal, Dr.

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

  PRINCIPAL INVESTIGATOR

• Marta Żołnowska, Lek. Med.

  Centrum Medyczne Plejady

  PRINCIPAL INVESTIGATOR

• Bogusław Cimoszko, Lek. Med.

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

  PRINCIPAL INVESTIGATOR

• Wanda Furmaga-Jabłonska, Prof.

  Uniwersytecki Szpital Dziecięcy w Lublinie

  PRINCIPAL INVESTIGATOR

• Marzena Nowak, Dr.

  Centrum Medyczne PROMED

  PRINCIPAL INVESTIGATOR

• Georgios Marek Vasilopoulos, Dr.

  Centrum Innowacyjnych Terapii Sp. z o.o.

  PRINCIPAL INVESTIGATOR

• Viktor Bauer, MD

  Dr. Kenessey Albert Kórház-Rendelőintézet

  PRINCIPAL INVESTIGATOR

• Robert Simkó, MD

  Futurenest Kft.

  PRINCIPAL INVESTIGATOR

• István Laki, MD

  Kanizsai Dorottya Kórház

  PRINCIPAL INVESTIGATOR

• Éva Kovács, MD

  Házi Gyermekorvosi Rendelő / Babadoki Kft.

  PRINCIPAL INVESTIGATOR

• Éva Szabó, MD

  Csolnoky Ferenc Kórház

  PRINCIPAL INVESTIGATOR

• István Tokodi, MD

  Mentaház Magánorvosi Központ Kft.

  PRINCIPAL INVESTIGATOR

• Zsuzsanna Tengelyi, MD

  Clinexpert Kft.

  PRINCIPAL INVESTIGATOR

• Katalin Fister, MD

  Clinexpert Gyöngyös Egészségügyi Szolgáltató Kft.

  PRINCIPAL INVESTIGATOR

• Anton Bilev, MD

  MC ''Sveti Ivan Rilski - Chudotvorets''

  PRINCIPAL INVESTIGATOR

• Miroslava Bosheva, MD

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

  PRINCIPAL INVESTIGATOR

• Toni Grigorov, MD

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

  PRINCIPAL INVESTIGATOR

• Rositsa Karcheva-Beloeva, MD

  Medical Center-1-Sevlievo

  PRINCIPAL INVESTIGATOR

• Margarita Koleva, MD

  Diagnostic-consultative center Ritam TR

  PRINCIPAL INVESTIGATOR

• Stelyana Kraeva, MD

  Alitera -Med-Medical Center

  PRINCIPAL INVESTIGATOR

• Olga Nikolova, MD

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

  PRINCIPAL INVESTIGATOR

• Tatyana Stoeva, MD

  Medical Centre - Izgrev

  PRINCIPAL INVESTIGATOR

• Irina Popova, MD

  University Hospital 'Deva Maria', Department for Naonatology

  PRINCIPAL INVESTIGATOR

• Svilen Dosev, MD

  Multiprofile Hospital for Active treatment Ruse AD, Department of Paediatrics

  PRINCIPAL INVESTIGATOR

• Stefan Banov, MD

  SMA Dr Stefan Banov

  PRINCIPAL INVESTIGATOR

• Sirma Dimitrova, MD

  Medical Center Excelsior

  PRINCIPAL INVESTIGATOR

• Malgorzata Arciszewska, MD

  Poliklinika Ginekolo.-Poloznicza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Unique coding of the study products
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2018
• First Posted: October 29, 2018
• Study Start: September 19, 2018
• Primary Completion: November 5, 2021
• Study Completion: January 19, 2022
• Last Updated: February 17, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

BU (13); HU (8); PL (13)