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NCT04441359
Long-term Safety and Efficacy of Prebiotic Enriched Infant Formula
NA trial testing Supplemented formula in Infection in 160 participants. Completed in 31 October 2010.
31 October 2010
Quick facts
| Lead sponsor | Beneo-Institute |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | basic science |
| Enrollment | 160 |
| Start date | 1 June 2008 |
| Primary completion | 31 October 2010 |
| Estimated completion | 31 October 2010 |
| Sites | 8 locations across Belgium, Spain |
Drugs / interventions tested
- Supplemented formula
- Standard formula
Conditions studied
- Infection — all drugs for Infection →
- Microbial Colonization — all drugs for Microbial Colonization →
- Healthy — all drugs for Healthy →
Sponsor
Beneo-Institute
Who can join
Adults 1 Day to 4 Months, any sex, with Infection or Microbial Colonization. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The primary objective of the present study was to evaluate the effects of long-term supplementation of an infant formula supplemented with prebiotic inulin-type oligosaccharides on immunological-health related outcomes.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Long-Term Safety and Efficacy of Prebiotic Enriched Infant Formula-A Randomized Controlled Trial.
Neumer F, Urraca O, Alonso J, Palencia J, et al · · 2021 · cited 21× · PMID 33924514 · DOI 10.3390/nu13041276
Verify or expand the search:
- PubMed search for NCT04441359
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other Beneo-Institute trials
Trials by the same sponsor.
- NCT05881018 — Investigating the Effects of Diet and Physical Activity on Esport Performance · NA · completed
- NCT05212545 — Effects of Prebiotics on Intestinal Colonization and Mood in a University Cohort · NA · completed
- NCT05581615 — Influence of Food Matrix on Prebiotic Efficacy in Inulin Type Fructans · NA · completed
- NCT04596709 — Investigation of Blood Glucose and Insulin Response After Intake of Vitalose · NA · completed
- NCT03457688 — Effect of Prebiotic Fructans to Reduce Number of Febrile Infections in Children · 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 NCT04441359 (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 Beneo-Institute
- Last refreshed: 22 June 2020
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/NCT04441359.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing