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NCT04055363: NEHMO
Human Milk Oligosaccharides (HMOs) Post-market Study on Infants
NA trial testing HMO-supplemented infant formula in Growth in 207 participants. Completed in 31 December 2018.
30 November 2018
Quick facts
| Lead sponsor | Société des Produits Nestlé (SPN) |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 207 |
| Start date | 1 October 2018 |
| Primary completion | 30 November 2018 |
| Estimated completion | 31 December 2018 |
| Sites | 6 locations across Spain |
Drugs / interventions tested
- HMO-supplemented infant formula
Conditions studied
- Growth — all drugs for Growth →
- Tolerance — all drugs for Tolerance →
- Adverse Event — all drugs for Adverse Event →
- Disorder of Intestine — all drugs for Disorder of Intestine →
Sponsor
Société des Produits Nestlé (SPN) — full company profile →
Who can join
Adults 7 Days to 2 Months, any sex, with Growth or Tolerance. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Human milk oligosaccharides (HMOs) represent the third largest solid component of breast milk. Technology advancements made it possible to supplement infant formulas with HMOs (2'FL, LNnT). Two published RCTs have demonstrated that infant formulas supplemented with 2'FL or 2'FL+LNnT are safe, well-tolerated, support normal grow, and may support healthy GI function and confer immune benefits. The performance of HMOs-supplemented formulas assessed in a real-world setting is complementary to previously conducted RCTs conducted in highly controlled clinical settings. Main objectives will be to monitor the safety \& tolerance of HMOs-supplemented formulas in larger and diverse infant populations; to assess the performance of HMOs-supplemented formulas in mixed-fed infants, a population that was not studied in previous RCTs but likely represents a relatively common feeding regimen. Finally, considering the potential health/immune benefits of HMOs, it is also important explore the incidences of illnesses (i.e., respiratory illnesses, GI illnesses, and fever) associated with consuming HMOs-supplemented formulas and compare with breastfed infants data.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04055363
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of HMO-supplemented infant formula
Trials testing the same drug.
- NCT05150288 — Human Milk Oligosaccharides (HMOs) Post-market Study on Infants (NEHMO) · NA · completed
Other recruiting trials for Growth
Currently open trials in the same condition.
- NCT06018636 — Impact of Diet and Nutrition on Growth and Development in Young Children · recruiting
Other Société des Produits Nestlé (SPN) trials
Trials by the same sponsor.
- NCT07312201 — Oral Nutritional Supplementation in Children With Growth Concerns · NA · not yet recruiting
- NCT07378111 — Vegetarian Tube Feed Study · NA · not yet recruiting
- NCT07439718 — The Effects of an Oral Nutritional Intervention on the Small Intestine Microbiome · NA · recruiting
- NCT07341464 — Acceptability and Tolerance Study of Bolus Tube Feed With Food Blends · NA · recruiting
- NCT07127198 — Tolerance and Appetite Reduction of a Nutritional Solution With Intragastric Gelation Properties · 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 NCT04055363 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Société des Produits Nestlé (SPN)
- Last refreshed: 13 August 2019
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/NCT04055363.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing