Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
240 participants
INTERVENTIONAL
2023-07-05
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Control formula group
The Control Formula group will receive 1st age infant formula exclusively for the first six months.
Control 1st age starter infant formula
A standard bovine milk-based term infant formula.
Experimental formula group
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.
Experimental 1st age starter infant formula
Same content as Control formula plus supplemented with a HMO blend and a probiotic
Interventions
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Control 1st age starter infant formula
A standard bovine milk-based term infant formula.
Experimental 1st age starter infant formula
Same content as Control formula plus supplemented with a HMO blend and a probiotic
Eligibility Criteria
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Inclusion Criteria
2. Infants whose parent(s)/LAR(s) have reached the legal age of majority in the countries where the study is conducted.
3. Able to temporarily store stool samples in a household freezer.
4. Infants whose parent(s)/LAR(s) are willing and able to comply with scheduled visits, and the requirements of the study protocol.
5. Infants whose parent(s)/LAR(s) are able to be contacted directly by telephone throughout the study.
1. Healthy term infant (≥37 weeks of gestation).
2. At enrollment visit, post-natal age ≥14 to ≤35 days / 0.75 - 1 month (date of birth = day 0)
3. Birth weight ≥ 2500g and ≤ 4500g.
4. For formula-fed groups, infants must be exclusively consuming and tolerating a cow's milk infant formula at time of enrollment and their parent(s)/LAR(s) must have independently elected, before enrollment, not to breastfeed.
5. For the breastfed group, infants must have 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 their parent(s)/LAR(s) must have made the decision to continue exclusively breastfeeding until at least 4 months of age.
Exclusion Criteria
2. 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:
1. Evidence of major congenital malformations (e.g., cleft palate, extremity malformation).
2. Suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus, syphilis).
3. 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 study. Of note, children who are normally healthy but at the time of enrolment suffering from acute illness in a minor condition which are common in childhood and do not require some of the exclusionary medication mentioned below can be enrolled.
3. 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.
4. Currently participating or having participated in another interventional clinical trial since birth.
14 Days
35 Days
ALL
Yes
Sponsors
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Iqvia Pty Ltd
INDUSTRY
Société des Produits Nestlé (SPN)
INDUSTRY
Responsible Party
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Principal Investigators
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Maria Rosario Capeding, Dr
Role: PRINCIPAL_INVESTIGATOR
Asian Hospital Medical Center
Mitzi Trinidad Aseron, Dr
Role: PRINCIPAL_INVESTIGATOR
University of Perpetual Help Dalta Medical Center
Vinna Marie Quinones, Dr
Role: PRINCIPAL_INVESTIGATOR
University of the East Ramon Magsaysay Memorial Medical Center
Locations
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Asian Hospital and Medical Center
Manila, , Philippines
University of Perpetual Help DALTA Medical Center
Manila, , Philippines
University of the East Ramon Magsaysay Memorial Medical Center
Manila, , Philippines
Countries
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Other Identifiers
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21.14.INF
Identifier Type: -
Identifier Source: org_study_id