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Human Milk Oligosaccharide (HMO) Supplementation in Colic Management

NCT05554991 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2024-06-14

No results posted yet for this study

Summary

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

Conditions

  • Colic

Interventions

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

Sponsors & Collaborators

  • Société des Produits Nestlé (SPN)

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Weeks
Max Age
12 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-24
Primary Completion
2024-04-30
Completion
2024-04-30

Countries

  • Italy
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05554991 on ClinicalTrials.gov