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China infant functional gastroenteropathy (FGIDs) research and intervention project

China infant functional gastroenteropathy (FGIDs) research and intervention project

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033937
Enrollment
Unknown
Registered
2020-06-17
Start date
2020-07-01
Completion date
Unknown
Last updated
2022-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

FGIDs in infants

Interventions

Case series:Feeding guidance, medical education and formula change

Sponsors

West China Second Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 0.8 Years

Inclusion criteria

Inclusion criteria: First stage: 1. 0-9-month-old single, full-term and suitable for gestational age; 2. Patients with reflux, abdominal colic, dysdefecation, constipation and diarrhea as clinical manifestations; 3. Patients who voluntarily participate and fill in informed consent. The second stage: 1.0-9 months old, single, full-term, suitable for gestational age; 2. Formula fed infants (regular formula of total lactose and whole protein); 3. In case of mixed feeding, the amount of breast milk shall not exceed 20% / day; 4. If she has been exclusively breastfed in the past, she should be weaned for more than 14 days; 5. FGIDs were diagnosed 2 days before treatment without any intervention; 6. Participate voluntarily and fill in the informed consent form.

Exclusion criteria

Exclusion criteria: The first stage 1. Patients that the researchers think are not suitable to participate in; 2. Patients who do not sign informed consent. The second stage 1. Infants with organic diseases (digestive, respiratory, nervous system infection, other digestive tract diseases, anatomical abnormalities, etc.); 2. Infants with congenital malformations (such as congenital heart disease, digestive tract malformation, etc.); 3. Infants with growth retardation; 4. Infants who have alarm symptoms and are unable to exclude organic diseases temporarily (for alarm symptoms, please refer to diagnosis and treatment intervention guidance tool for details); 5. Infants with potential milk protein allergy risk who may need low sensitivity formula; 6. Patients who have previously taken other unconventional formulas (such as low lactose formula, partial hydrolysis formula, deep hydrolysis formula, amino acid formula, etc.); 7. Infants who had used gastrointestinal motility drugs 7 days before treatment, which may affect the test results; 8. The researchers think it is not suitable for the infants in the group (such as the researchers' poor judgment compliance, unable to strictly implement the program, etc.).

Design outcomes

Primary

MeasureTime frame
Efficacy of regurgitation;Efficacy of colic;Efficacy of functional constipation;

Secondary

MeasureTime frame
Efficacy of regurgitation;Efficacy of colic;Efficacy of dyschezia;Efficacy of functional diarrhea;Growth of infant;Nutritional management satisfaction;

Countries

China

Contacts

Public ContactZhiling Wang

West China Second Hospital of Sichuan University

wang_zhi_ling@126.com+86 13608072906

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026