WithdrawnNot Applicable

Evaluation of A Partially Hydrolyzed in Improving FGIDs Symptoms

Stopped: no funding

0Started 2018-07-05

Plain-language summary

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

Who can participate

Age range

1 Month – 6 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change of total symptom score of infant feeding & stool pattern questionnaire.

Timeframe: From enrollment to end of treatment（1 week）. The scores will be measured at the following time point: enrollment,end of treatment(one week after the start of treatment).

Trial details

NCT IDNCT03390309

SponsorChildren's Hospital of Fudan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-12-30

View on ClinicalTrials.gov More Functional Gastrointestinal Disorders trials

Who can participate

Age range

1 Month – 6 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.