Second Generation Human Milk Oligosaccharides Blend Study
Launched by SOCIÉTÉ DES PRODUITS NESTLÉ (SPN) · Oct 24, 2018
Trial Information
Current as of June 26, 2025
Completed
Keywords
ClinConnect Summary
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 examp...
Gender
ALL
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.
- 6. Infants must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- • 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
About Société Des Produits Nestlé (Spn)
Société des Produits Nestlé (SPN) is a global leader in nutrition, health, and wellness, dedicated to advancing scientific research and innovation in the food and beverage sector. As a subsidiary of Nestlé S.A., SPN focuses on developing high-quality products that promote healthier lifestyles and improve overall well-being. The organization actively sponsors clinical trials to evaluate the efficacy and safety of its nutritional offerings, collaborating with healthcare professionals and research institutions to gather valuable insights that inform product development and public health initiatives. Through its commitment to evidence-based research, SPN aims to enhance consumer trust and contribute to the advancement of nutritional science.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Lublin, , Poland
Budapest, , Hungary
Veszprém, , Hungary
Székesfehérvár, , Hungary
Kraków, , Poland
Piaseczno, , Poland
Bydgoszcz, , Poland
Sevlievo, , Bulgaria
Kraków, , Poland
Blagoevgrad, , Bulgaria
Burgas, , Bulgaria
Kozloduy, , Bulgaria
Montana, , Bulgaria
Plovdiv, , Bulgaria
Ruse, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Stara Zagora, , Bulgaria
Stara Zagora, , Bulgaria
Balassagyarmat, , Hungary
Gyöngyös, , Hungary
Miskolc, , Hungary
Nagykanizsa, , Hungary
Szeged, , Hungary
Białystok, , Poland
Gdańsk, , Poland
Gdańsk, , Poland
Kraków, , Poland
Ostrołęka, , Poland
Rzeszów, , Poland
Tarnów, , Poland
Warsaw, , Poland
Patients applied
Trial Officials
Aleksander Krasnow, Lek. Med.
Principal Investigator
Gdańskie Centrum Zdrowia Sp. Z o.o.
Wiesław Olechowski, Dr n.med.
Principal Investigator
ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. Z o.o.
Sylwia Korzyńska, MD
Principal Investigator
Centrum Medyczne Pratia Ostrolęka
Anna Płoszczuk, Dr. n.med.
Principal Investigator
Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny Anna Płoszczuk
Magdalena Sidorowicz, Dr.
Principal Investigator
Centrum Medyczne Pratia Warszawa
Grażyna Jasieniak-Pinis, Lek. Med.
Principal Investigator
ATOPIA Niepubliczny Zakład Opieki Zdrowotnej Poradnie Specjalistyczne
Bartosz Korczowski, PhD MD Dr
Principal Investigator
Korczowski Bartosz Gabinet Lekarski
Piotr Korbal, Dr.
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.
Principal Investigator
Centrum Medyczne Plejady
Bogusław Cimoszko, Lek. Med.
Principal Investigator
Clinical Vitae Sp z o.o. Poradnia Podstawowej Opieki Zdrowotnej
Wanda Furmaga-Jabłonska, Prof.
Principal Investigator
Uniwersytecki Szpital Dziecięcy w Lublinie
Marzena Nowak, Dr.
Principal Investigator
Centrum Medyczne PROMED
Georgios Marek Vasilopoulos, Dr.
Principal Investigator
Centrum Innowacyjnych Terapii Sp. z o.o.
Viktor Bauer, MD
Principal Investigator
Dr. Kenessey Albert Kórház-Rendelőintézet
Robert Simkó, MD
Principal Investigator
Futurenest Kft.
István Laki, MD
Principal Investigator
Kanizsai Dorottya Kórház
Éva Kovács, MD
Principal Investigator
Házi Gyermekorvosi Rendelő / Babadoki Kft.
Éva Szabó, MD
Principal Investigator
Csolnoky Ferenc Kórház
István Tokodi, MD
Principal Investigator
Mentaház Magánorvosi Központ Kft.
Zsuzsanna Tengelyi, MD
Principal Investigator
Clinexpert Kft.
Katalin Fister, MD
Principal Investigator
Clinexpert Gyöngyös Egészségügyi Szolgáltató Kft.
Anton Bilev, MD
Principal Investigator
MC ''Sveti Ivan Rilski - Chudotvorets''
Miroslava Bosheva, MD
Principal Investigator
University Multiorofile Hospital for active treatment Sveti Georgi EAD, Pediatric clinic
Toni Grigorov, MD
Principal Investigator
Multiprofile Hospital for Active Treatment City Clinic - Sveti Georgi EOOD,Department of Paediatrics,
Rositsa Karcheva-Beloeva, MD
Principal Investigator
Medical Center-1-Sevlievo
Margarita Koleva, MD
Principal Investigator
Diagnostic-consultative center Ritam TR
Stelyana Kraeva, MD
Principal Investigator
Alitera -Med-Medical Center
Olga Nikolova, MD
Principal Investigator
Multiprofile Hospital for Active Treatment Sveti Ivan Rilski Kozloduy,Department of Pediatrics
Tatyana Stoeva, MD
Principal Investigator
Medical Centre - Izgrev
Irina Popova, MD
Principal Investigator
University Hospital 'Deva Maria', Department for Naonatology
Svilen Dosev, MD
Principal Investigator
Multiprofile Hospital for Active treatment Ruse AD, Department of Paediatrics
Stefan Banov, MD
Principal Investigator
SMA Dr Stefan Banov
Sirma Dimitrova, MD
Principal Investigator
Medical Center Excelsior
Malgorzata Arciszewska, MD
Principal Investigator
Poliklinika Ginekolo.-Poloznicza
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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