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| Name | Class |
|---|---|
| IQVIA Pty Ltd | INDUSTRY |
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This randomized, double-blind, controlled intervention trial aims to evaluate the safety and efficacy of a starter infant formula supplemented with an HMO blend and a probiotic, and will provide evidence on the safety and efficacy of the innovative prebiotic/ probiotic blend to support age-appropriate infant growth, a healthy gut microbiome, gastrointestinal (GI) tolerance and GI health, and immune development.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control formula group | Active Comparator | The Control Formula group will receive 1st age infant formula exclusively for the first six months. |
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| Experimental formula group | Experimental | The Experimental Formula group will receive 1st age infant formula identical to Control formula, but supplemented with a HMO blend and a probiotic exclusively for the first six months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control 1st age starter infant formula | Other | A standard bovine milk-based term infant formula. |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety of experimental formula demonstrated by growth | Weight gain comparison between infants from experimental and control group | Baseline Visit 1 to 4 months of age Visit 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of experimental formula demonstrated by fecal sIgA concentration. | Concentration of sIgA in fecal samples | Baseline Visit 1 to 4 months of age Visit 5 |
| Fecal microbiome | Fecal microbiota modulating effect |
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Inclusion Criteria:
Evidence of personally signed and dated informed consent document indicating that at least one of the infant's parent(s)/LAR(s), as per local regulation, have been informed of all pertinent aspects of the study.
Infants whose parent(s)/LAR(s) have reached the legal age of majority in the countries where the study is conducted.
Able to temporarily store stool samples in a household freezer.
Infants whose parent(s)/LAR(s) are willing and able to comply with scheduled visits, and the requirements of the study protocol.
Infants whose parent(s)/LAR(s) are able to be contacted directly by telephone throughout the study.
Infants must meet all of the following inclusion criteria to be eligible for enrollment into the study:
Exclusion Criteria:
Infants with conditions requiring infant feedings other than those specified in the protocol.
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 enrolment 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 microbiota and characteristics (e.g., oral, or 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 interventional clinical trial since birth.
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| Name | Affiliation | Role |
|---|---|---|
| Maria Rosario Capeding, Dr | Asian Hospital Medical Center | Principal Investigator |
| Mitzi Trinidad Aseron, Dr | University of Perpetual Help Dalta Medical Center | Principal Investigator |
| Vinna Marie Quinones, Dr | University of the East Ramon Magsaysay Memorial Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asian Hospital and Medical Center | Manila | Philippines | ||||
| University of Perpetual Help DALTA Medical Center |
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There are two masked, randomized formula-fed intervention groups, Control Formula (CF) and experimental Formula (EF)
| Experimental 1st age starter infant formula | Other | Same content as Control formula plus supplemented with a HMO blend and a probiotic |
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| Baseline Visit 1 to 6 month of age Visit 6 |
| Fecal metabolic profile | Fecal pH, fecal organic acids measurement from fecal samples | Baseline Visit 1 to 6 month of age Visit 6 |
| Fecal markers of immune health and gut barrier function | Fecal markers of immune health and gut barrier, such as but not restricted to calprotectin and α-1-antitrypsin assessed by ELISA. | Baseline Visit 1 to 6 month of age Visit 6 |
| Fecal cytokine profile | Fecal cytokine profile (such as but not restricted to: IL-6, IL-8, IL-1b, IL-22, IFN-γ) using multiplex assays. | Baseline Visit 1 to 6 month of age Visit 6 |
| Blood markers of systemic immunity | Immunotyping and plasma immune proteomics and Vaccine specific antibodies measurement from blood samples | Baseline Visit 1 to 4 months of age Visit 5 |
| 3-day GI Symptom and Behavior Diary | GI tolerance, GI symptoms and GI-related behaviors | Baseline Visit 1 to 6 month of age Visit 6 |
| Infant Gastrointestinal Symptom Questionnaire (IGSQ-13) Index questionnaire | GI tolerance, GI symptoms and GI-related behaviors | Baseline Visit 1 to 6 month of age Visit 6 |
| Weight (g) | Anthropometric measurement. Weight and height will be combined to report BMI in kg/m^2 | Baseline Visit 1 to 6 month of age Visit 6 |
| Length (cm) | Anthropometric measurement. Weight and height will be combined to report BMI in kg/m^2 | Baseline Visit 1 to 6 month of age Visit 6 |
| Head circumference (cm) | Anthropometric measurement | Baseline Visit 1 to 6 month of age Visit 6 |
| Respiration | Vital signs | Baseline Visit 1 to 6 month of age Visit 6 |
| Heart rate | Vital signs | Baseline Visit 1 to 6 month of age Visit 6 |
| Body temperature | Vital signs | Baseline Visit 1 to 6 month of age Visit 6 |
| Physical examination | Infant illness and infection outcomes | Baseline Visit 1 to 3 years of age Observational Follow Up Visit 5 |
| Pediatric Immune System Index and Infant Illness Questionnaire | Infant illness and infection outcomes | Baseline Visit 1 to 3 years of age Observational Follow Up Visit 5 |
| Antibiotic and antipyretic use | Concomitant medication reporting | Baseline Visit 1 to 6 month of age Phone visit 7 |
| Manila |
| Philippines |
| University of the East Ramon Magsaysay Memorial Medical Center | Manila | Philippines |