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Feeding Intervention for Infants With Crying

NCT01017991 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2017-11-17

No results posted yet for this study

Summary

The purpose of the study is to assess if infants who have excessive crying and fussing have less of these symptoms when fed a formula containing a probiotic compared to those fed a standard infant formula.

Conditions

  • Crying

Interventions

OTHER

Milk based infant formula with probiotic

formula supplied as a powder to be constituted as commercially available formula ad libitum daily 28 days duration

OTHER

Milk based infant formula

supplied as a powder to be constituted as commercially available formula ad libitum daily 28 days

Sponsors & Collaborators

  • Société des Produits Nestlé (SPN)

    lead INDUSTRY

Principal Investigators

  • Michael D Cabana, MD,MPH · University of California, San Francisco, USA

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Weeks
Max Age
4 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2012-08-31
Completion
2013-03-31

Countries

  • United States

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 NCT01017991 on ClinicalTrials.gov