A Longitudinal Cohort Study on the Changes of Physiological Mechanisms in Children After Biliary Tract Reconstruction

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 16
SponsorWuhan Children's Hospital

About this trial

Through observational studies, the long-term changes in liver function, metabolic state, immune response and other aspects of children after biliary tract reconstruction during their growth process were systematically explored. The risks of these long-term physiological changes on chronic diseases such as cardiovascular diseases, diabetic diseases and liver cirrhosis in adulthood, as well as their impacts on cognitive function, musculoskeletal health and other aspects were evaluated. How do early physiological changes affect a patient's long-term health? Are there any potential biomarkers that can predict future health outcomes? Based on the research results, preventive and intervention measures that are helpful in reducing the risk of long-term complications are proposed.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy children matched by age and gender were selected as the control group

Disqualifiers

Combined with other serious diseases (such as cancer, autoimmune diseases), having obvious liver function abnormalities before surgery or being undergoing other major treatments.

Trial population

Children who were diagnosed with biliary atresia or choledochal cyst after birth and underwent biliary reconstruction surgery were selected. According to the year Stratified by factors such as age, gender and operation time to ensure the representativeness of the samples.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 2 trial groups
Group A: Children diagnosed with biliary atresia or choledochal cyst and undergoing biliary reconstruction
Group B: Healthy children matched by age and gender were selected as the control group

Trial outcomes

Primary outcomes

1

Targeted metabolic component detection of feces

Metabolite concentration in feces measured by targeted metabolomics

Time frame
Baseline (pre-operative); 1 week, 1 month, 3 months, 6 months, 1 year, 2 years, 3 years post-operative
2

Detection of targeted metabolic components in plasma

Metabolite concentration in plasma measured by targeted metabolomics

Time frame
Baseline (pre-operative); 1 week, 1 month, 3 months, 6 months, 1 year, 2 years, 3 years post-operative

Secondary outcomes

1

Fecal metagenomic sequencing

Gut microbial composition and functional genes assessed by fecal metagenomic sequencing

Time frame
Baseline (pre-operative); 1 week, 1 month, 3 months, 6 months, 1 year, 2 years, 3 years post-operative

Other outcomes

Sponsors and contacts

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