# BIG Study (Brain, Immune, and Gut Health Evaluation of Infants/Young Children Fed Infant Formula, and Later Supplemental Toddler Nutrition, With 5 Specific HMOs)

> **NCT04957992** · NA · COMPLETED · sponsor: **Abbott Nutrition** · enrollment: 607 (actual)

## Conditions studied

- Growth

## Interventions

- **OTHER:** Control Infant Formula
- **OTHER:** Control Toddler Drink
- **OTHER:** Experimental Infant Formula
- **OTHER:** Experimental Toddler Drink
- **OTHER:** Human Milk
- **OTHER:** Human Milk Supplemental Formula
- **OTHER:** Human Milk Toddler Drink

## Key facts

- **NCT ID:** NCT04957992
- **Lead sponsor:** Abbott Nutrition
- **Sponsor class:** INDUSTRY
- **Phase:** NA
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2021-07-21
- **Primary completion:** 2025-05-12
- **Final completion:** 2025-05-12
- **Target enrollment:** 607 (ACTUAL)
- **Last updated:** 2025-06-27


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04957992

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04957992, "BIG Study (Brain, Immune, and Gut Health Evaluation of Infants/Young Children Fed Infant Formula, and Later Supplemental Toddler Nutrition, With 5 Specific HMOs)". Retrieved via AI Analytics 2026-06-08 from https://api.ai-analytics.org/clinical/NCT04957992. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*