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A single-arm multicentre clinical study of a partially hydrolysed protein lactose-reducing formula for the treatment of functional dyspepsia syndrome in infant and and toddler

A single-arm multicentre clinical study of a partially hydrolysed protein lactose-reducing formula for the treatment of functional dyspepsia syndrome in infant and and toddler

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082704
Enrollment
Unknown
Registered
2024-04-03
Start date
2024-05-01
Completion date
Unknown
Last updated
2024-04-08

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

Conditions

Functional dyspepsia syndrome in infants and toddler

Interventions

Trial group:Partially hydrolysed protein lactose-reducing formula

Sponsors

Women and Children's Medical Center, Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 0.5 Years

Inclusion criteria

Inclusion criteria: 1. 0-5 months of age, full-term, suitable for foetal age children 2. Exclusively artificially fed (i.e., on the day of the consultation, the parents of the subject confirmed that the child was exclusively artificially fed without the addition of any breast milk). 3. Functional dyspepsia syndrome in infants and toddler is diagnosed. 4. Formula selection is regular formula (non-special medical use formula) 5. Guardians voluntarily participate and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Parents did not consent to participate in the study; 2. Breastfeeding or mixed feeding children; 3. Are using other special medical formulas; 4. Have used or are using antibiotics and other supplements (probiotics, prebiotics, synbiotics, postbiotics) within 2 weeks; 5. Are using or have used gastrointestinal medications (PPIs, gastrointestinal motility medications, digestive enzymes, lactase, corticosteroids, proprietary medications for digestive discomfort, B and C vitamins, etc.) in the 7 days prior to the visit; 6. Presence of serious diseases (e.g., severe digestive, respiratory, neurological infections, other digestive diseases, anatomical abnormalities of the digestive tract, congenital malformations, growth retardation, etc.); 7. Presence of serious heart, brain, liver, kidney and haematopoietic system, connective tissue diseases, endocrine diseases, and psychiatric disorders; 8. Participation in other clinical studies within 12 weeks prior to screening; 9. Infants in whom organic diseases cannot be excluded for the time being.

Design outcomes

Primary

MeasureTime frame
Symptom score for functional dyspepsia syndrome in infants and toddler;

Secondary

MeasureTime frame
Fecal intestinal flora;calreticulin;Stool Acetic, Propionic and Butyric Acid Levels;sIgA;Symptom score for functional dyspepsia syndrome in infants and toddler;Rate of disappearance of individual symptoms;Weight;length;

Countries

China

Contacts

Public ContactSitang Gong

Guangzhou Women and Children's Medical Center,Guangzhou Medical University

sitangg@126.com+86 189 0226 8811

Outcome results

None listed

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