Evaluation of A Partially Hydrolyzed in Improving FGIDs Symptoms

Fudan University

Status: Withdrawn

Conditions: Functional Gastrointestinal Disorders

Treatments: Other: Partially Hydrolyzed Formula; Other: Normal Formula

Study type: Interventional

Funder types: Other

Identifiers

NCT03390309

Fudan-AN 001

Details and patient eligibility

About

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

Full description

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.

Sex: All

Ages: 1 to 6 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups, including a placebo group

Partially Hydrolyzed Formula

Other group

Description:

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

Treatment:

Other: Partially Hydrolyzed Formula

Normal Formula

Placebo Comparator group

Description:

Normal Formula

Treatment:

Other: Normal Formula