NCT05150288: NeHMO DACH

Human Milk Oligosaccharides (HMOs) Post-market Study on Infants (NEHMO)

Completed NA Last updated 9 December 2021

What this trial tests

NA trial testing HMO-supplemented infant formula in Growth in 106 participants. Completed in 24 July 2020.

Timeline

8 July 2019

Primary endpoint
24 July 2020

24 July 2020

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	106
Start date	8 July 2019
Primary completion	24 July 2020
Estimated completion	24 July 2020
Sites	17 locations across Austria, Switzerland, Germany

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

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Real-world evidence study on tolerance and growth in infants fed an infant formula with two human milk oligosaccharides vs mixed fed and exclusively breastfed infants.
   Jochum F, Meyer-Krott M, Hübler T, Lorenz M, et al · · 2023 · cited 4× · PMID 37597076 · DOI 10.1186/s40348-023-00162-6