NCT05554991

Human Milk Oligosaccharide (HMO) Supplementation in Colic Management

Efficacy and Tolerability of a Composition Comprising of HMO in a Supplement Format on Colic Management: a Double-blind, Randomized, Placebo-controlled Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 2 Weeks – 12 Weeks
• Healthy volunteers: Not accepted

Summary

Efficacy and tolerability of a composition comprising of HMO in a supplement format on colic management: a double-blind, randomized, placebo-controlled trial

Detailed description

This is a double-blinded, randomized, placebo-controlled trial. The purpose of this trial is to investigate the efficacy and tolerability of a composition comprising of HMO in a supplement format in the management of colicky infants aged 2-12 weeks.

Conditions

• Colic

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	HMO	Composition comprising of HMO
DIETARY_SUPPLEMENT	Placebo	Placebo supplementation having the same appearance and dosing regimen as the intervention
BEHAVIORAL	Parental reassurance and support	Both groups will receive standardized written materials to provide parental reassurance and support, in alignment with local clinical practice

Timeline

• Start date: 2022-06-24
• Primary completion: 2024-04-30
• Completion: 2024-04-30
• First posted: 2022-09-26
• Last updated: 2024-06-14

Locations

7 sites across 2 countries: Italy, Spain