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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group (EG) | Experimental | Starter infant formula supplemented with two HMOs. Following the intervention period, the infants will consume a standard infant follow-up formula (non-trial formula). |
|
| Control Group (CG) | Active Comparator | Starter infant formula not supplemented with two HMOs. Following the intervention period, the infants will consume a standard infant follow-up formula (non-trial formula). |
|
| Breastfed Group (BG) | No Intervention | Breast Milk |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental Group (EG) | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Bifidobacteria abundance in fecal samples | Bifidobacteria abundance using qPCR technology | just prior to 3 months of age |
| Measure | Description | Time Frame |
|---|---|---|
| Gut microbiota composition | Relative abundance of beneficial and potentially pathogenic species using next generation sequencing (NGS) technology | From enrollment until 12 months of age |
| Fecal metabolism |
| Measure | Description | Time Frame |
|---|---|---|
| Formula feeding | Total quantity of milk consumed for formula-feeding | From enrollment until 12 months of age |
| Breastfeeding | The frequency of breastfeeding, duration and type of breastfeeding (exclusive, predominant, partial) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiaoji Li | Contact | 008613910051543 | qiaoji.li@rd.nestle.com | |
| Joyce Li | Contact | 008615810125435 | Joyce.Li@rd.nestle.com |
| Name | Affiliation | Role |
|---|---|---|
| Wei Cai, MD | Shanghai Institute for Pediatric Research, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The International Peace Maternity & Child Health Hospital of China Welfare Institute | Recruiting | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41172301 | Derived | Wang Y, Le Roy CI, Li J, Han S, Liu Z, Lahiry A, Sahu H, Li Q, Dong J, Mondragon A, Samuel TM, Cai W. Efficacy of a Ready-to-Feed Starter Liquid Infant Formula Containing 2-Fucosyllactose and Lacto-N-Neotetraose in Chinese Infants: Protocol for a Double Blind, Randomized Controlled Trial. JMIR Res Protoc. 2025 Oct 31;14:e66489. doi: 10.2196/66489. |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Control Group (CG) | Other | 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). |
|
Fecal pH analyzed using HPLC as well as targeted or untargeted metabolomics profiling
| From enrollment until 12 months of age |
| Fecal metabolism | Short chain fatty acids analyzed using HPLC as well as targeted or untargeted metabolomics profiling | From enrollment until 12 months of age |
| Fecal markers of intestinal immune health | Fecal secretory IgA measured by ELISA | From enrollment until 6 months of age |
| Fecal markers of gut barrier function | Calprotectin measured by ELISA | From enrollment until 6 months of age |
| Fecal markers of gut barrier function | α-1-antitrypsin measured by ELISA | From enrollment until 6 months of age |
| Fecal markers of gut barrier function | Lipocalin-2 measured by ELISA | From enrollment until 6 months of age |
| Fecal markers of inflammation | Levels of cytokines such as IL-1β measured by ELISA | From enrollment until 6 months of age |
| Fecal markers of inflammation | Levels of cytokines such as IFN-γ measured by ELISA | From enrollment until 6 months of age |
| Fecal markers of inflammation | Levels of cytokines such as TNF-α measured by ELISA | From enrollment until 6 months of age |
| Stool patterns | Stool frequency, consistency, and difficulty in passing stools assessed using a 1-day retrospective stool consistency diary (24-hr recall) | From enrollment until 14 days |
| Stool patterns | Stool frequency, consistency, and difficulty in passing stools assessed using a 3-day prospective collection recorded in the stool consistency diary. | From enrollment until 12 months of age |
| GI symptoms and behaviors | IGSQ-13 Questionnaire | From enrollment until 6 months of age |
| Immune competence | Pediatric Immune System Index score | From enrollment until 12 months of age |
| Infant sleep duration and night-time wakings per 24 hours | Brief infant sleep questionnaire (BISQ) | From enrollment until 6 months of age |
| Infant Health Related Quality of Life | Infant Toddler Quality of Life Questionnaire (ITQoL -SF47) | From enrollment until 6 months of age |
| Growth | Weight (g) and corresponding Z-scores | From enrollment until 12 months of age |
| Growth | Length (cm) and corresponding Z-scores | From enrollment until 12 months of age |
| Growth | Head circumference (cm) and corresponding Z-scores | From enrollment until 12 months of age |
| Growth | Weight gain and corresponding Z-scores | From enrollment until 12 months of age |
| Growth | Length gain, corresponding Z-scores | From enrollment until 12 months of age |
| Physical Examination | At enrollment and at 12 months of age |
| Infant Illness | Infant Illness Diary | From enrollment until 12 months of age |
| Infant illness, infections and medication usage | AEs and Serious Adverse Events (SAEs) | From the time the informed consent form has been signed at enrollment infant age less than 3 days until 12 months of age |
| Medication use (type and duration) | Concomitant medication form and Infant Illness Diary | From enrollment until 12 months of age |
| From enrollment until 12 months of age |
| Infant dietary pattern | 3-day food diary | From 6 months of age until 12 months of age |
| D008722 | Methods |