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Post-market Surveillance Study of an Infant Formula Containing Moderately Hydrolyzed Protein and Low Lactose

NCT04112056 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2020-04-02

No results posted yet for this study

Summary

The study is a before-after trial to evaluate whether the study formula containing moderately hydrolyzed protein and low lactose will be able to improve mild gastrointestinal disorders (MGDs) in infants. The study plans to recruit 90 infants between 7 days and 6 months old in Huantai Maternal and Child Health Care Hospital in Shandong Province and intervene for 14 consecutive days. On Day 0 (the time of enrolling group, but the intervention which infants recruited are asked to drink study formula begins on Day 1), Day 7, Day 14, Infant Gastrointestinal Symptoms Questionnaire-13 (IGSQ-13) is used to collect infants gastrointestinal comfort, related behaviors and other information.

Conditions

  • Infant Nutrition Disorders
  • Gastrointestinal Dysfunction

Interventions

DIETARY_SUPPLEMENT

Drink the study formula (NAN Comfort producted by Nestle Deutschland AG)

It is same as that stated in arm description.

Sponsors & Collaborators

  • Huantai Maternal and Child Health Care Hospital

    collaborator UNKNOWN

  • Peking University

    lead OTHER

Principal Investigators

  • Jian-meng Liu, PhD · Peking University

  • Ying-chao Mu, BD · Huantai Maternal and Child Health Care Hospital

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Days
Max Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-10
Primary Completion
2020-04-30
Completion
2020-05-15

Countries

  • China

Study Locations

More Related Trials

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 NCT04112056 on ClinicalTrials.gov