| Title |
Feeding tolerance and gut maturation of infants consuming a formula rich in osteopontin: A single-arm, open-label, prospective interventional study including a breastfed reference group |
| Description |
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 BF infants as reference group.Infants and their parents / caregivers will participate in 2 clinic visits (V1 and V2), complete 3 at-home assessments (2 stool collections and a 3-day GI diary completion) and participate in 1 telephone call over the 6-week intervention period. An additional phone call will occur 14 days after the end of the intervention period.The primary objective of this clinical trial is to demonstrate non-inferior IGSQ index score in FF group compared to BF group after 6 weeks of intervention. |
| Organism |
Homo sapiens |
| Data Type |
Biomarker Data |
| Data Accessibility |
Controlled-access |
| BioProject |
PRJCA015973 |
| Release Date |
2025-03-14 |
| Submitter |
Ying Wang (wangying_ssmu@126.com) |
| Organization |
Shanghai Institute for Pediatric Research |
| Submission Date |
2023-03-31 |