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Enterobacteria capsules in the treatment of patients with ulcerative colitis with depression clinical research on effectiveness and safety

Enterobacteria capsules in the treatment of patients with ulcerative colitis with depression clinical research on effectiveness and safety

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049538
Enrollment
Unknown
Registered
2021-08-02
Start date
2021-08-09
Completion date
Unknown
Last updated
2022-04-19

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

Conditions

Ulcerative colitis with depression

Interventions

experimental group:FMT capsules intervention

Sponsors

Army Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. The course of disease is more than 6 months, and the diagnosis is ulcerative colitis with depression [Diagnostic criteria reference: (2020) "JSGE Evidence-based Clinical Practice Guidelines: Inflammatory Bowel Disease" and "Chinese Classification and Diagnostic Criteria for Mental Disorders" (CCMD) -3), and meet the modified Mayo score = 5 points]; 2. Men and women are not limited, the age is between 18-65 years old; 3. BMI between 18-30kg/m2; 4. Have basic reading comprehension skills; 5. No other serious diseases of the heart, brain, lung, liver, kidney, etc.; 6. Have not traveled abroad in the past 1 month, and have no history of alcoholism, drug addiction, or travel; 7. No use of antibiotics and probiotics within 1 month; 8. Agree to participate in this study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Authors with bipolar affective disorder, persistent mood disorder, and mania; 2. Gastrointestinal infection, irritable bowel syndrome, bowel cancer and other malignant tumors and other gastrointestinal diseases; 3. A history of gastrointestinal surgery; 4. Pregnancy and lactation patients; 5. Complicated with severe chronic diseases (hereditary, metabolic, endocrine diseases) such as obesity, hypertension, diabetes, heart disease, and stroke; 6. Infectious diseases: hepatitis B or C, HIV, syphilis (positive plasma rapid recovery), Epstein-Barr virus and cytomegalovirus infection (IgM positive); 7. Abnormal liver function: AST or ALT higher than 2 times the upper limit of normal; renal insufficiency: serum Cr higher than 1.5 times the upper limit of normal or eGFR 4.0 mmol/L, TG >2.0 mmol/L, LDL-c>2.5 mmol/L, HDL-c8 mg/L; 8. Anticoagulation therapy; 9. Patients who are participating in other clinical trials at the time of enrollment; 10. Those who do not agree to be enrolled or have various factors that affect compliance and are not suitable for participating in clinical trials.

Design outcomes

Primary

MeasureTime frame
PHQ9 Scores;

Secondary

MeasureTime frame
gut microbiota;Conlonscopy Mayo index;Anxiety and Depression Scale Assessment;

Countries

China

Contacts

Public ContactWei Yanling

Army Medical Center

lingzi016@126.com+86 15310354666

Outcome results

None listed

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