Efficacy of Two HMOs in Chinese Infants
ConditionHealthy Infants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-14
SponsorSociété des Produits Nestlé (SPN)
About this trial
This is a randomized, controlled, double-blind, intervention trial of healthy male and female term infants to evaluate the efficacy of the 2 HMOs on beneficially modulating the gut microbiota, gut maturation, gut barrier integrity, immune response, and other developmental outcomes in healthy Chinese infants. The trial consists of 2 randomized formula-fed groups, and a non-randomized breastfed reference group.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Experimental Group (EG)
- Control Group (CG)
Treatment groups
262 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov