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| Name | Class |
|---|---|
| Merieux NutriSciences (China) | UNKNOWN |
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The aim of this randomized, controlled, multi-center, double-blind study of healthy term infants is to test the safety and efficacy of a new infant formula with a specific blend of six human milk oligosaccharides. The primary objective of the trial is to demonstrate the safety of the new infant formula supplemented by comparing the growth of infants randomized to the experimental formula versus the control formula from enrollment to the age of 4 months. The study has an interventional phase up to 6 months of age including 5 visits followed by an observational phase up to 12 months of age for a subgroup of the first 50 breastfed infants and the first 110 formula-fed infants including 2 additional visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group | Experimental | New infant formula with 6 HMOs blend |
|
| Control group | Active Comparator | Standard infant formula without 6 HMOs blend |
|
| Reference group | No Intervention | Breastfeeding |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New infant formula with 6 HMOs blend | Other | Infants are fed with HMO formula from the date of enrollment to the age of 6 months, exclusive formula feeding until the age of 4 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight gain (g/day) between enrollment and the age of 4 months | until the age of 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Fecal secretory IgA (mg/g dry feces) at the age of 4 months corrected for baseline values | until the age of 4 months | |
| Weight (g) at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively | until the age of 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Faecal markers of immune health and gut inflammation and barrier integrity at baseline, the age of 4 months, 6 months and 12 months respectively | calprotectin, α-1-antitrypsin, lipocalin-2, claudin-3, cathelicidin, α-defensin and β-defensin assessed by ELISA | until the age of 12 months |
| Illnesses and infections based on standard AE/SAE reporting |
Inclusion Criteria:
Exclusion Criteria:
Conditions requiring infant feedings other than those specified in the protocol.
Medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results, including:
Presently receiving or have received prior to enrollment any 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 gut microbiota (e.g., oral, or 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 interventional clinical trial since birth.
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| Name | Affiliation | Role |
|---|---|---|
| Wei CAI, MD, Ph.D. | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Jining Medical College | Jining | China | ||||
| Shanghai Public Health Clinical Center affiliated to Fudan University |
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Test group: infant formula with 6 HMOs blend; Control group: infant formula without 6 HMOs blends
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| Standard infant formula without 6 HMOs blend | Other | Infants are fed with standard formula from the date of enrollment to the age of 6 months, exclusive formula feeding until the age of 4 months. |
|
| Body length (cm) at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively | until the age of 12 months |
| Body length gain (cm/week) at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively | until the age of 12 months |
| Head circumference (cm) at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively | until the age of 12 months |
| Head circumference gain (cm/week) at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively | until the age of 12 months |
| Weight-for-age WHO growth standard z-scores at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively | until the age of 12 months |
| Length-for-age WHO growth standard z-scores at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively | until the age of 12 months |
| Weight-for-length WHO growth standard z-scores at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively | until the age of 12 months |
| Head-circumference-for-age WHO growth standard z-scores at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively | until the age of 12 months |
| Weight gain (g/day) between enrollment and the age of 6 months and 12 months respectively | until the age of 12 months |
| Stool pattern, GI symptoms and GI-related behaviors recorded in the retrospective 1-day questionnaire at baseline and in the prospective 3-day GI Symptom and Behavior Diary for 3 days prior to the age of 42 days, 3 months, 4 months, 6 months | until the age of 6 months |
| Fecal microbiome composition, diversity, community type assessed by NGS sequencing at baseline, the age of 4 months, 6 months and 12 months respectively | until the age of 12 months |
| Fecal acetic acid, propionic acid, butyric acid, isobutyric acid, valeric acid, isovaleric acid, and total short chain fatty acids at baseline, the age of 4 months, 6 months and 12 months respectively | until the age of 12 months |
| Fecal pH at baseline, the age of 4 months, 6 months and 12 months respectively | until the age of 12 months |
| Fecal secretory IgA (mg/g dry feces) at the age of 6 months corrected for baseline values | until the age of 6 months |
| until the age of 12 months |
| Medication use based on standard AE/SAE reporting | until the age of 12 months |
| Breastmilk composition assessed by HPLC at baseline, the age of 42 days, 4 months and 6 months respectively | until the age of 6 months |
| Shanghai |
| China |
| Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | China |
| The Third People's Hospital affiliated to Hebei Medical University | Shijiazhuang | China |
| The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine | Tianjin | China |