Status:
COMPLETED
Growth, Safety and Efficacy of a Probiotic Supplement
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Probiotic Supplement
Eligibility:
All Genders
14-21 years
Phase:
NA
Brief Summary
The primary objective of the study is to demonstrate the safety of a daily high dose of a probiotic supplement by comparing the growth (weight gain, g/day) of formula-fed and/or breastfed infants in h...
Detailed Description
This is a randomized, placebo-controlled, double-blind study of healthy term infants, consisting of three randomized arms: placebo control group, high dose experimental group, and low dose experimenta...
Eligibility Criteria
Inclusion
- 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 access to a working freezer.
- Infants must meet all the following inclusion criteria to be eligible for enrolment into the study:
- Healthy term (37-42 weeks of gestation) infant at birth.
- At enrolment visit, post-natal age 14-21 days (date of birth = day 0)
- Birth weight ≥ 2500g and ≤ 4500g.
- Breastfed and/or formula-fed infants (including exclusively and mixed fed breast- and formula-fed infants) whose parent(s)/LAR intent not to change the feeding regimen until the study end at 8 weeks of intervention.
- Formula-fed infants and their parent(s)/LAR must have independently elected, before enrolment not to breastfeed and their infant must tolerate a standard cow's milk infant formula not containing any probiotics at time of enrolment.
Exclusion
- Infants with conditions requiring specific infant feeding regimens 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:
- Evidence of major congenital malformations (e.g., cleft palate, extremity malformation).
- Suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus, syphilis).
- History of admission to the Neonatal Intensive Care Unit (NICU), except for admission for jaundice phototherapy.
- Other 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.
- 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 (e.g., 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.
Key Trial Info
Start Date :
February 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 12 2021
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT04765852
Start Date
February 26 2021
End Date
October 12 2021
Last Update
March 24 2023
Active Locations (1)
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1
Asian Foundation for Tropical Medicine, Inc.
City of Muntinlupa, Philippines, 1781