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The distribution of intestinal microbiota and the mechanism of cholestasis in children with Citrin deficiency

The distribution of intestinal microbiota and the mechanism of cholestasis in children with Citrin deficiency

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200058149
Enrollment
Unknown
Registered
2022-03-31
Start date
2022-07-01
Completion date
Unknown
Last updated
2023-12-03

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

Conditions

neonatal intrahepatic cholestasis caused by citrin deficiency

Interventions

Citrin deficiency group :Intestinal microbiota analysis
Biliary atresia group:Intestinal microbiota analysis
healthy infants group:Intestinal microbiota analysis

Sponsors

Fujian Provincial Maternity and Children’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 0.3 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for Citrin deficiency: 1) Meeting the diagnostic criteria for cholecasis: a. If total bilirubin >75umol/L, direct bilirubin/total bilirubin >20%; B. If total bilirubin 17umol/L, conforming to either A or B is diagnosed as cholestasis. 2) Normal birth weight for full-term infants less than 3 months old. 3) Genetic diagnosis of SLC25A13 variation. Inclusion criteria for biliary atresia: 1) Meet the diagnostic criteria for cholestasis. 2) Normal birth weight for full-term infants less than 3 months old. (3) Biliary atresia was confirmed by intraoperative laparoscopic cholangiography and pathological. Inclusion criteria of healthy group: normal full-term infants who came to hospital for physical examination less than 3 months ago.

Exclusion criteria

Exclusion criteria: Citrin deficiency exclusion criteria: 1) congenital abnormalities, birth defects. 2) Older than 3 months, premature birth, abnormal birth weight. 3) Complicated with other serious diseases. 4) Probiotics, antibiotics and proton pump inhibitors were used 2 weeks before feces collection. Exclusion criteria for biliary atresia: 1) congenital abnormalities and birth defects. 2) Older than 3 months, premature birth, abnormal birth weight. 3) Complicated with other serious diseases. 4) Probiotics, antibiotics and proton pump inhibitors were used 2 weeks before feces collection. Exclusion criteria for healthy infants group: 1) congenital abnormalities and birth defects. 2) Older than 3 months, premature birth, abnormal birth weight. 3) Complicated with other serious diseases. 4) Probiotics, antibiotics and proton pump inhibitors were used 2 weeks before feces collection.

Design outcomes

Primary

MeasureTime frame
cholestasis;

Secondary

MeasureTime frame
cholestasis;

Countries

China

Contacts

Public ContactLin Yijun
58646812@qq.com+8615980232660

Outcome results

None listed

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