Efficacy of Two HMOs in Chinese Infants

Launched by SOCIÉTÉ DES PRODUITS NESTLÉ (SPN) · Apr 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of two types of human milk oligosaccharides (HMOs) on the health of healthy Chinese infants. HMOs are special sugars found in breast milk that can help support a baby’s gut health, immune system, and overall development. The trial includes two groups of formula-fed infants who will receive different HMOs and a group of breastfed infants for comparison. The goal is to see how these HMOs can positively influence the babies' gut bacteria and other important health markers.

To participate in the trial, infants need to be healthy boys or girls aged between 3 to 14 days old, born full-term, and weighing between 2.5 kg and 4.5 kg. Parents must agree to the study and be able to attend scheduled visits. Infants who are exclusively breastfed or those who are on cow's milk formula can join, but those with certain health conditions or who have recently taken specific medications may not be eligible. Participants can expect regular check-ups and monitoring throughout the study to ensure their health and gather valuable information about how HMOs affect infant development.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Healthy male and female infants of post-natal age of 3-14 days (date of birth = day 0), inclusive, at enrolment
• • Evidence of personally signed and dated informed consent document indicating that the infant's parent(s)/ legally accepted representatives LAR have been informed of all pertinent aspects of the trial.
• • Infants whose parent(s) have reached the legal age of majority in China.
• • Infants whose parent(s)/LAR are willing and able to comply with scheduled visits, and the requirements of the trial protocol.
• • Infants whose parent(s)/LAR can be contacted directly by telephone throughout the trial.
• • Infants whose parent(s)/LAR have a working freezer.
• • Singleton, healthy, full-term gestational birth (≥ 37 completed weeks of gestation), with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg.
• • For the formula-fed groups: infant is exclusively consuming and tolerating a cow' s milk infant formula for at least 3 days prior to enrolment. The infant's mother has independently elected not to breastfeed.
• • For the breastfed reference group: infant has been exclusively consuming breastmilk since birth and the infant's mother has made the decision to continue exclusively breastfeeding until at least 3 months of age.
• Exclusion Criteria:
• • 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 enrolment.
• • Infants who have a medical condition or history that could increase the risk associated with trial participation or interfere with the interpretation of trial results, including: Evidence of major congenital malformations (e.g., cleft palate, extremity malformation). Documented or suspected systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus, syphilis). Previous or ongoing severe medical or laboratory abnormality (acute or chronic) which, in the judgment of the investigator, would make the infant inappropriate for entry into the trial.
• • Infants who are presently receiving or have received prior to enrolment probiotic supplements or 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 and microbiota (e.g., oral and systemic antibiotics, glycerine suppositories, bismuth-containing medications, docusate, Maltsupex, or lactulose); growth (e.g. insulin or growth hormone); gastric acid secretion.
• • Currently participating or having participated in another clinical trial since birth.
• • Infant who has known or suspected cows' milk protein intolerance / allergy, lactose intolerance, soy intolerance / allergy.