Evaluation of A Partially Hydrolyzed in Improving FGIDs Symptoms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-05

Study Completion Date

2019-06-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Evaluation of A Partially Hydrolyzed Whey Protein Infant Formula in Improving Functional Gastrointestinal Disorders (FGIDs) Symptoms

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Tolerance of Healthy Term Infants Fed Infant Formulas #3

NCT00977964

Gastrointestinal Tolerance

COMPLETED PHASE3

The Influence of Feeding Source on the Gut Microbiome and Time to Full Feeds in Neonates With Congenital Gastrointestinal Pathologies

NCT06072976

Gastrointestinal Complication Intestinal Obstruction Gastroschisis +3 more

UNKNOWN NA

Feeding Intolerance in Formula-Fed Infants

NCT02028156

Feeding Intolerance

TERMINATED NA

Gastrointestinal Tolerance And General Health Status Of Healthy Term Infants Fed A New Infant Formula

NCT01370967

Healthy

COMPLETED

Assessment of Gastrointestinal Discomfort and Infections in Healthy Term Infants

NCT06744699

Gastrointestinal Symptoms Infection Allergy Symptoms +1 more

ACTIVE_NOT_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study will investigate the prevalence of Shanghai area's infant with FGIDs symptom and contrast for the FGIDs symptoms by using different intervention means, and evaluate the effectiveness of FGIDs symptoms in infants by using partially hydrolyzed whey protein and low lactose infant formulation.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Functional Gastrointestinal Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Partially Hydrolyzed Formula

Infant was identified and got 1 or more scores by using infant feeding \& stool pattern questionnaire at Visit 1 will be assigned into experimental group randomly

Group Type OTHER

Partially Hydrolyzed Formula

Intervention Type OTHER

Partially Hydrolyzed Whey Protein Infant Formula

Normal Formula

Group Type PLACEBO_COMPARATOR

Normal Formula

Intervention Type OTHER

Normal Formula

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Partially Hydrolyzed Formula

Partially Hydrolyzed Whey Protein Infant Formula

Intervention Type OTHER

Normal Formula

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Infants is formula-fed or mixed feeding a cow milk protein-based formula for less 7 days prior to enrollment.
* Infant is between 30-180 days of age.
* Infant's parent(s) or Legally authorized representative(LAR) has voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) prior to any participation in the study.

Exclusion Criteria

* Complementary food was added for infants or parents are willing to add complementary food during study.
* Suffer from infection/illness.
* Infant has suspected or known metabolic or physical diseases affecting infant feeding and/or metabolism.
* Infant has visible bloody stools (detected before enrollment) prior to enrollment.
* Participation in another study.

Minimum Eligible Age

1 Month

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes