Skip to content

Clinical randomized controlled study on the improvement effect of probiotics on lactose intolerance in infants and young children

Clinical randomized controlled study on the improvement effect of probiotics on lactose intolerance in infants and young children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100839
Enrollment
Unknown
Registered
2025-04-16
Start date
2025-04-20
Completion date
Unknown
Last updated
2025-04-21

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

Conditions

lactose intolerant in Infants

Interventions

Control group:none
Lactose intolerance group:None
Placebo group:Lactose intolerance + lactase + placebo
Probiotic group:Lactose intolerance + lactase + probiotic

Sponsors

Jingdezhen Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: 1. Infants 0 to 12 months old who meet the standard diagnosis of lactose intolerance have normal weight and height. Diagnostic criteria for neonatal lactose intolerance: (1) Related symptoms, including abdominal distension, increased frequency of defecation, and increased frequency of milk vomiting. (2) Laboratory indicators: fecal reducing sugar >= 0.25% or fecal pH <=5.5. 2. The patients are generally in good condition and have no other serious heart, lung, kidney, liver dysfunction and metabolic diseases. 3. No antibiotics or other drugs or probiotics were used in the first 3 months after the completion of treatment.

Exclusion criteria

Exclusion criteria: 1. Patients who did not meet the inclusion criteria. 2. Have a severe active viral or bacterial infection that is not controlled by treatment. 3. A history of birth asphyxia (1-minute Apgar score < 7). 4. There are serious congenital malformations, such as digestive tract malformations, congenital heart disease, etc. 5. Peripheral blood eosinophilia is considered to be milk protein allergy. 6. Suspected or confirmed neonatal necrotizing enterocolitis (NEC) . 7. There are serious infections, elevated hemolytic liver enzymes, thrombocytopenia (HELLP) syndrome, tumors and other diseases in the mother's pregnancy. 8. Have any other serious or chronic medical condition that the investigators believe may affect the treatment, follow-up, or evaluation of the child. It includes any uncontrolled and clinically significant neurological, psychiatric, immune-regulatory, metabolic and infectious diseases. 9. Children who are not suitable for probiotic adjuvant therapy after diagnosis and evaluation by clinicians.

Design outcomes

Primary

MeasureTime frame
Biochemical function;immunoglobulin;Composition of gut microbiota;

Countries

China

Contacts

Public ContactXuewei Lei

Jingdezhen Second People's Hospital

13879806471@163.com+86 138 7980 6471

Outcome results

None listed

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