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Study on the intestinal microflora characteristics and TCM syndromes of patients with hepatocellular carcinoma complicated with intestinal dysfunctio

Phase 1
Conditions
Primary hepatic carcinoma
Registration Number
ITMCTR2200005950
Lead Sponsor
Changhai Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

(1) Patients with hepatocellular carcinoma complicated with intestinal dysfunction.
(2) A history of hepatitis B cirrhosis.
(3) Child-Pugh=8, ascites quantity was grade 1.
(4) Aged 18-75, male or female, out-patient or inpatient in our department.
(5) The course of disease is more than 6 months, and the patient has persistent abdominal discomfort or pain in the last 3 months, accompanied by at least 2 of the following characteristics:
1.Abnormal frequency of defecation (defecation >3 times a day or <3 times a week);
2.Abnormal fecal traits (lumpy/hard or watery stools);
3.abnormal fecal discharge process (effort, urgency, sense of exhaustion);
4.Mucinous stool;
5.Gastrointestinal flatulence or abdominal distension.

Exclusion Criteria

(1) The patient's Child-Pugh was C, or the BCLC stage was D.
(2) The patient had moderate or large ascites or had upper gastrointestinal bleeding.
(3) Used gastric acid inhibitors (proton pump inhibitors and H2 receptor antagonists), microbial agents, antibacterial drugs, metformin or non-absorbable disaccharides (such as lactilose) that affect intestinal flora, or targeted therapy drugs such as sorafenib, ramvaritinib and anlotinib within the last 4 weeks.
(4) Patients with rheumatic immune diseases or systemic inflammation such as bacterial infection in the last 3 months.
(5) White blood cells detected by routine stool microscopy were > 3 / high magnification field.

Study & Design

Study Type
Observational study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
the intestinal microflora characteristics;
Secondary Outcome Measures
NameTimeMethod
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