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| Name | Class |
|---|---|
| Medrio, Inc | UNKNOWN |
| SAS Institute | INDUSTRY |
| Veeva Systems | INDUSTRY |
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This is a non-randomized, single-arm, open-label, prospective interventional study using a commercially available starter infant formula in healthy term formula-fed infants with a parallel group of healthy term breast-fed infants as reference group. Approximately 120 male and female infants (60 per group) who are 3-28 days old and are exclusively or predominately formula-feeding or breastfeeding will be enrolled.
Breastmilk contains an abundance of structurally diverse compounds having important physiologic roles. These include glycoproteins which are biologically active and involved in infant gut, immune and brain development (Jiang and Lönnerdal 2016).
The overall purpose of this study is to study the effectiveness of a term infant formula rich in glycoprotein (formula-fed group) on gastrointestinal tolerance, and gastrointestinal health in healthy term infants compared to a breast-fed reference group. We hypothesize that there will be comparable gastrointestinal tolerance in formula-fed and breast-fed and that fecal bifidobacteria changes in early infancy in the formula-fed group are similar to that of breast-fed infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Formula-Fed (FF) Group | Experimental | Subjects will be fed commercial bovine milk-based, whey-predominant, α-lactalbumin-enriched term formula with high sn-2 palmitate fat blend, supplemented with oligofructose for 6 weeks. |
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| Breast-Fed (BF) Group | No Intervention | Subjects will continue exclusive/ predominant breastfeeding for 6 weeks. Breastmilk may be consumed directly from the breast or breast milk may be expressed and fed through infant feeding bottle. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Commercially Available Starter Infant Formula | Dietary Supplement | Study formula is provided in powder form and will be administered orally, ad libitum, via an infant feeding bottle and the volume of formula offered to the infant will be guided by the recommended feeding table for the age group or by physician recommendation. The amount consumed by the infant will vary by each infant's weight and appetite. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall gastrointestinal (GI) tolerance | Compare the overall gastrointestinal (GI) tolerance between the formula-fed and the breast-fed infants from enrolment to 6 weeks of intervention. Assessed through the IGSQ-13 (Infant Gastrointestinal Symptoms Questionnaire). The IGSQ-13, consisting of 13 questions, is a retrospective, standardized, validated, questionnaire of GI symptoms and related behaviors that the infant experienced over the past week from a parent's perspective. Overall GI tolerance is assessed from the IGSQ index score, computed from the 13 questions. Possible scores range from 13 - 65, with lower scores representing lower overall GI burden. | Day 39-45 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Bifidobacteria abundance | Change in Bifidobacteria abundance from baseline to be measured in the stool samples collected. | Day 1, Day 36-44 |
| Fecal microbiota | Overall fecal microbiota composition and diversity and community type. Diversity will include relative abundance of beneficial and pathogenic bacteria species (such as beneficial bifidobacteria diversity). To be measured in stool samples collected. |
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Inclusion Criteria:
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 study.
Infants whose parent(s)/LAR have reached the legal age of majority in the countries where the study is conducted.
Infants whose parent(s)/LAR are willing and able to comply with scheduled visits, and the requirements of the study protocol.
Infants whose parent(s)/LAR can be contacted directly by telephone throughout the study.
Infants whose parent(s)/LAR have a working freezer.
Infants must meet all the following inclusion criteria to be eligible for enrolment into the study:
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 enrollment.
Infants who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results, including:
Infants who are presently receiving or have received prior to enrollment 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, glycerin 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.
Subjects or subjects' parent(s) or legal representative who are not willing and not able to comply with scheduled visits and the requirements of the study protocol.
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| Name | Affiliation | Role |
|---|---|---|
| Ying Wang | Shanghai Institute for Pediatric Research at Xinhua Hospital, Shanghai Jiao Tong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Public Health Clinical Center | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42363297 | Derived | Wang Y, Liu M, Dogra SK, Vidal K, Godin JP, Darwish N, Wei X, Reymond L, Li Q, Dong J, Vyllioti AT, Bettler J, Kennedy E, Wang K, Zhai Q, O'Regan J, Samuel TM, Cai W. Effects of an infant formula containing a whey protein concentrate on feeding tolerance and markers of intestinal immune defense in Chinese infants. BMC Nutr. 2026 Jun 26. doi: 10.1186/s40795-026-01395-0. Online ahead of print. |
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| Day 1, Day 36-44 |
| Fecal metabolism | To be measured in stool samples collected. The metabolic profile consist of pH and organic acids (such as but not restricted to acetate, lactate, butyrate, and propionate), analyzed using HPLC. | Day 1, Day 36-44 |
| GI immunity assessed from fecal markers | To be measured in stool samples collected. Fecal markers include fecal secretory IgA measured by ELISA. Cytokine profile (such as, but not restricted to: IL-1ra, IL1-alpha, IL-1beta, IL-6, IFN-gamma, and TNF-alpha) measured by multiplex assays. OPV-specific IgA measured by ELISA. | Day 1, Day 36-44 |
| GI maturation assessed from fecal markers | To be measured in stool samples collected. Includes fecal markers of GI health and maturation assessed by ELISA, such as but not restricted to α-1-antitrypsin and lipocalin. | Day 1, Day 36-44 |
| Stool characteristics: Stool frequency | Stool frequency using the 1-day and 3-day Stooling and Milk Intake Diary. | Day 0, Day 36-44 |
| Stool characteristics: Difficulty in passing stool | Difficulty in passing stool using the 1-day and 3-day Stooling and Milk Intake Diary. | Day 0, Day 36-44 |
| Stool characteristics: Stool consistency | Stool consistency using a 5-point scale in the 1-day and 3-day Stooling and Milk Intake Diary. | Day 0, Day 36-44 |
| GI-related behaviors: Stooling | Baby bowel movements using the individual IGSQ (Infant Gastrointestinal Symptoms Questionnaire) questions. | Day 0, Day 39-45 |
| GI-related behaviors: Incidence of spitting-up | Incidence of spitting-up using the individual IGSQ (Infant Gastrointestinal Symptoms Questionnaire) questions. | Day 0, Day 39-45 |
| GI-related behaviors: Crying time | Baby crying time using the individual IGSQ (Infant Gastrointestinal Symptoms Questionnaire) questions. | Day 0, Day 39-45 |
| GI-related behaviors: Fussiness | Baby fussiness using the individual IGSQ (Infant Gastrointestinal Symptoms Questionnaire) questions. | Day 0, Day 39-45 |
| GI-related behaviors: Incidence of flatulence | Flatulence using the individual IGSQ (Infant Gastrointestinal Symptoms Questionnaire) questions. | Day 0, Day 39-45 |
| Milk intake (Breast-Fed infants) | Total number of feedings using the 1-day and 3-day Stooling and Milk Intake Diary. | Day 0, Day 36-44 |
| Milk intake (Formula-Fed infants) | Total number of feedings and total quantity of milk consumed for every formula-feeding using the 1-day and 3-day Stooling and Milk Intake Diary. | Day 0, Day 36-44 |
| Infant quality of life | Assessed from the Infant Quality of Life Questionnaire (IQI). The IQI is a short, age-appropriate, and relevant tool that assesses 8 health-related domains in infants up to 1 year. The domains are sleeping, feeding, breathing, stooling, mood, skin, interaction and other health problems. | Day 0, Day 39-45 |
| Growth: Weight of the infant | Weight in grams and corresponding weight-for-age Z-score according to the WHO growth standards. | Day 0, Day 39-45 |
| Growth: Length of the infant | Length in centimeters and corresponding length-for-age Z-score according to the WHO growth standards. | Day 0, Day 39-45 |
| Growth: Weight-for-length of the infant | Corresponding weight-for-length Z-score according to the WHO growth standards. | Day 0, Day 39-45 |
| Growth: Head circumference of the infant | Head circumference in centimeters and corresponding head-circumference-for-age Z-score according to the WHO growth standards. | Day 0, Day 39-45 |
| Growth: Body mass index (BMI) of the infant | Weight and height will be combined to report the BMI (kg/m2) and corresponding BMI-for-age Z-score according to the WHO growth standards. | Day 0, Day 39-45 |
| Safety assessment: Infant illness | As part of the standard adverse events (AEs) reporting for safety assessment. | Day 0 through 14 days after Day 39-45 |
| Safety assessment: Infection outcomes | As part of the standard adverse events (AEs) reporting for safety assessment. | Day 0 through 14 days after Day 39-45 |
| Safety assessment: Medication use | As part of the standard adverse events (AEs) reporting for safety assessment. | Day 0 through 14 days after Day 39-45 |