Maintenance hemodialysis,Slow Transit Constipation
Conditions
Interventions
Experimental group:Oral Intestinal Microbiota Transplant Capsules
Sponsors
Shandong First Medical University Affiliated Central Hospital Nephrology and Hemodialysis Center
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 - 70 years old. Gender: No restrictions. 2. Diagnosed with end-stage renal disease and undergoing maintenance hemodialysis treatment for at least 3 months, with a frequency of 2-3 times per week. 3. Meet the clinical diagnostic type of slow transit constipation based on the Rome IV criteria: • Satisfy the diagnostic criteria for adult functional constipation as per Rome IV. • Must include at least 2 of the following: >25% of defecations are strenuous (at least once every 4 times, the same below); >25% of defecations are dry or hard stools (in line with the Bristol stool form scale type 1-2); >25% of defecations have a feeling of incomplete evacuation; >25% of defecations have a sensation of anal rectal obstruction (or blockage); =>25% of defecations require manual assistance; weekly spontaneous defecation is less than 3 times. • Without using laxatives, there is almost no soft stool. • Not meeting the diagnostic criteria for IBS (Irritable Bowel Syndrome). • Clinical features tend to be of the slow transit type (at least 2 of the following are met). • At least 75% of defecations per week are of Bristol type 1 or 2. • The spontaneous defecation frequency is less than 3 times per week as the main characteristic. • Poor response or dependence to osmotic laxatives (such as polyethylene glycol). 4. Voluntarily sign the informed consent form and be able to cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Secondary constipation (e.g., due to clearly diagnosed diabetic bowel disease, hypothyroidism, Parkinson's disease, spinal cord injury, etc.). 2. Organic colorectal lesions (e.g., tumors, inflammatory bowel disease) or history of major intestinal surgery. 3. Severe anorectal dysfunction primarily manifested as requiring persistent manual assistance for defecation. 4. Recent (within 4 weeks) use of antibiotics, proton pump inhibitors, immunosuppressants, or probiotics. 5. Concurrent severe cardiac, hepatic, or pulmonary insufficiency (NYHA Class III-IV heart failure, Child-Pugh Class B/C) or life expectancy <12 months. 6. Presence of FMT contraindications (e.g., severe immunodeficiency, dysphagia). 7. Any other condition deemed unsuitable for study participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of completely spontaneous bowel movements per week; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bowel movement frequency, stool consistency, straining sensation during bowel movements;Quality of Life Related to Constipation;Severity of Constipation;Changes in the Gut Microbiome;Metabolic changes; | — |
Countries
China
Contacts
Public ContactRuibin Zhang
Shandong First Medical University Affiliated Central Hospital
Outcome results
None listed