Feeding Tolerance and Gut Maturation of Infants Consuming a Formula Rich in Glycoprotein (NCT04880083) | Clinical Trial Compass
CompletedNot Applicable
Feeding Tolerance and Gut Maturation of Infants Consuming a Formula Rich in Glycoprotein
China120 participantsStarted 2021-07-09
Plain-language summary
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.
Who can participate
Age range3 Days – 28 Days
SexALL
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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.