Healthy Infants
Conditions
Keywords
Human Milk Oligosaccharides, Infant gut microbiota, Infant gut health, Immune response, Growth, Tolerance
Brief summary
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.
Interventions
OTHERExperimental Group (EG)
Starter infant formula will be administered to the participants orally, ad libtium to 6 months, after which they will transfer to a classical follow-up formula (non-trial formula) until the end of the trial (12 months of age).
OTHERControl Group (CG)
Starter infant formula will be administered to the participants orally, ad libtium to 6 months, after which they will transfer to a classical follow-up formula (non-trial formula) until the end of the trial (12 months of age).
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Days to 14 Days
Healthy volunteers
Yes
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 (small amounts of other feedings allowed during the first three days of life before breastfeeding is well-established) 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bifidobacteria abundance in fecal samples | just prior to 3 months of age | Bifidobacteria abundance using qPCR technology |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fecal markers of intestinal immune health | From enrollment until 6 months of age | Fecal secretory IgA measured by ELISA |
| Infant sleep duration and night-time wakings per 24 hours | From enrollment until 6 months of age | Brief infant sleep questionnaire (BISQ) |
| Infant illness, infections and medication usage | From the time the informed consent form has been signed at enrollment infant age less than 3 days until 12 months of age | AEs and Serious Adverse Events (SAEs) |
| Medication use (type and duration) | From enrollment until 12 months of age | Concomitant medication form and Infant Illness Diary |
| Infant Health Related Quality of Life | From enrollment until 6 months of age | Infant Toddler Quality of Life Questionnaire (ITQoL -SF47) |
| Growth | From enrollment until 12 months of age | Weight (g) and corresponding Z-scores |
| Physical Examination | At enrollment and at 12 months of age | — |
| Infant Illness | From enrollment until 12 months of age | Infant Illness Diary |
| Gut microbiota composition | From enrollment until 12 months of age | Relative abundance of beneficial and potentially pathogenic species using next generation sequencing (NGS) technology |
| Fecal metabolism | From enrollment until 12 months of age | Fecal pH analyzed using HPLC as well as targeted or untargeted metabolomics profiling |
| Fecal markers of gut barrier function | From enrollment until 6 months of age | Calprotectin measured by ELISA |
| Fecal markers of inflammation | From enrollment until 6 months of age | Levels of cytokines such as IL-1β measured by ELISA |
| Stool patterns | From enrollment until 14 days | Stool frequency, consistency, and difficulty in passing stools assessed using a 1-day retrospective stool consistency diary (24-hr recall) |
| GI symptoms and behaviors | From enrollment until 6 months of age | IGSQ-13 Questionnaire |
| Immune competence | From enrollment until 12 months of age | Pediatric Immune System Index score |
Other
| Measure | Time frame | Description |
|---|---|---|
| Infant dietary pattern | From 6 months of age until 12 months of age | 3-day food diary |
| Formula feeding | From enrollment until 12 months of age | Total quantity of milk consumed for formula-feeding |
| Breastfeeding | From enrollment until 12 months of age | The frequency of breastfeeding, duration and type of breastfeeding (exclusive, predominant, partial) |
Countries
China
Contacts
Primary ContactQiaoji Li
Backup ContactJoyce Li
Outcome results
None listed