Last reviewed · How we verify
NCT04059666
Gastrointestinal Tract Microbiome in Healthy Term Infants Receiving Mother'S-own Breast Milk or Cow's Milk-based Infant Formulas
NA trial testing Investigational in Gastrointestinal Microbiome in 57 participants. Terminated before completion.
2 February 2022
Quick facts
| Lead sponsor | Mead Johnson Nutrition |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | other |
| Enrollment | 57 |
| Start date | 5 March 2019 |
| Primary completion | 2 February 2022 |
| Estimated completion | 2 February 2022 |
| Sites | 5 locations across United States |
Drugs / interventions tested
- Investigational
- Control
Conditions studied
- Gastrointestinal Microbiome — all drugs for Gastrointestinal Microbiome →
Sponsor
Mead Johnson Nutrition — full company profile →
Who can join
Adults 7 Days to 18 Days, any sex, with Gastrointestinal Microbiome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This clinical trial will compare stool and oral microbiome composition between infants fed breast milk or one of two infant formulas for a 60 day feeding period.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Microbiota, metabolic profiles and immune biomarkers in infants receiving formula with added bovine milk fat globule membrane: a randomized, controlled trial.
Christensen C, Kok CR, Harris CL, Moore N, et al · · 2024 · cited 1× · PMID 39444571 · DOI 10.3389/fnut.2024.1465174
Verify or expand the search:
- PubMed search for NCT04059666
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Investigational
Trials testing the same drug.
- NCT05548595 — A Study to Evaluate the Impact of a Nutritional Product on Cognition in Healthy Teenagers · NA · completed
- NCT04859231 — Nutritive Effects of Cow's Milk-Based Formulas Through 18 Months of Age · NA · terminated
- NCT03223792 — Acceptance Of A Partially-Hydrolyzed Infant Formula · NA · completed
Other recruiting trials for Gastrointestinal Microbiome
Currently open trials in the same condition.
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Other Mead Johnson Nutrition trials
Trials by the same sponsor.
- NCT07513506 — Extensively Hydrolyzed Formula Growth Monitioring Study (GMS) · NA · not yet recruiting
- NCT07498192 — Thai Baby Study Phase 1 · not yet recruiting
- NCT06318117 — Reason for Prescribing Rice Infant Formula · completed
- NCT05744193 — Feeding Study in VLBW Premature Infants · NA · terminated
- NCT05247879 — Clinical Effectiveness and Safety of a Novel Oral Rehydration Solution · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04059666 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mead Johnson Nutrition
- Last refreshed: 25 August 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04059666.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing