🏛️ Verified NIH Record • Updated 2025-09-23

Effects of Complementary Feeding on Infant Growth and Gut Health (NCT05012930)

🔵 Active, Not Recruiting Observational / Diagnostic 📋 Clinical Research Protocol Sponsor: University of Colorado, Denver

🩺 Plain-English Summary (8th-Grade Level)

This study plans to learn more about how consuming different foods during the time of early complementary feeding (\~5 to 12 months) affects growth and the development of bacteria living inside your baby's gut through school-age. The results from this study will potentially help to support future recommendations and dietary guidance for infant feeding practices. The three primary aims include: Aim 1. Identify the impact of dietary patterns with different protein-rich foods on infant growth. Aim 2. Identify the impact of dietary patterns with different protein-rich foods on infant gut microbiota development. Aim 3. Identify gut microbial taxa and genes that affect infant growth.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (7 items).

Location: University of Colorado Anschutz Medical Campus — Aurora, Colorado

Age range: 4 Months to 60 Months

🧪 Interventions in This Study

  • Baby Foods - Meat (OTHER)
  • Baby Foods - Dairy (OTHER)
  • Baby Foods - Plant (OTHER)
  • Foods from the home (OTHER)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Pre-term infants.
  • Having conditions that would affect normal growth
  • Had complementary foods prior to the start of the study
  • Not willing to consume the complementary foods provided
  • Antibiotics exposure during delivery or from birth to 5 months of life
  • Multiple births

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

  • University of Colorado Anschutz Medical Campus — Aurora, Colorado

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Gut Microbiome clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗