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To explore whether probiotics can improve infant functional constipation through the effect of intestinal flora of gut microbacteria

To explore whether probiotics can improve infant functional constipation through the effect of intestinal flora of gut microbacteria

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073079
Enrollment
Unknown
Registered
2023-06-30
Start date
2023-07-01
Completion date
Unknown
Last updated
2023-07-02

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

Conditions

Infantile functional constipation

Interventions

Model 1:Without intervention, conventional treatment only (oral lactulose)
Model 2:conventional treatment (oral lactulose) combined with oral probiotics (Lactobacillus plantarum)

Sponsors

The Second People's Hospital of Jingdezhen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
0.5 Years to 3 Years

Inclusion criteria

Inclusion criteria: ? Infants aged 6-36 months who meet the Rome IV criteria for functional gastroenteropathy in children have normal weight and height. Rome IV diagnostic criteria for functional gastroenteropathy in children. ? The patients are generally in good condition and have no other serious heart, lung, kidney, liver dysfunction and metabolic diseases. ?No antibiotics or other drugs or probiotics were used in the first 3 months after the completion of treatment.

Exclusion criteria

Exclusion criteria: ? Organic constipation, such as congenital megacolon, congenital rectal and anal deformity caused by organic diseases such as constipation. ?Have a severe active viral or bacterial infection that is not controlled by treatment. Have any other serious or chronic medical conditions that the investigator believes may affect the patient's treatment, follow-up, or evaluation. ?It includes any uncontrolled and clinically significant neurological, psychiatric, immune-regulatory, metabolic and infectious diseases. ?Patients who are not suitable for probiotic-assisted therapy after diagnosis and evaluation by clinicians.

Design outcomes

Primary

MeasureTime frame
Fecal flora;Wexner constipation score;

Countries

China

Contacts

Public ContactXuewei Lei

Jingdezhen Second People's Hospital

1055745004@qq.com+86 138 7980 6471

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 3, 2026