Constipation
Conditions
Interventions
Intervention group:Microbiota transplantation combined with prebiotics
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 to 70 years old; 2. Diagnostic criteria: Functional constipation (FC) meeting the Rome IV criteria, requiring the following conditions: (1) Symptom requirements: At least 2 of the following in =25% of defecations: 1) Straining during bowel movements; 2) Hard stools (Bristol Stool Form Scale types 1-2); 3) Sensation of incomplete evacuation; 4) Sensation of anorectal obstruction; 5) Need for manual maneuvers to facilitate defecation; 6) Spontaneous bowel movements <3 times per week. (2) Loose stools are rare without laxative use. (3) Exclusion of irritable bowel syndrome (IBS): Does not meet the Rome IV diagnostic criteria for IBS. (4) Duration requirement: Symptoms persist for at least 6 months and meet the above criteria in the past 3 months. 3. Poor response to conventional treatments (dietary interventions, at least 2 types of laxatives or probiotics). 4. Patients are willing to stop using prescription or over-the-counter medications, traditional Chinese medicine, Chinese patent medicine, or dietary supplements for constipation during the screening and treatment periods;
Exclusion criteria
Exclusion criteria: 1. History or significant clinical manifestations of mechanical intestinal obstruction (such as intestinal obstruction caused by intestinal tumors or hernias); 2. Patients with megacolon or pseudo-obstruction; 3. Suspected or confirmed organic abnormalities of the intestine (obstruction, stricture, malignancy) or inflammatory bowel disease; 4. Patients with progressive intestinal polyps requiring treatment; 5. History of gastrointestinal or abdominal surgery within 3 months prior to the screening period; 6. Severe cardiovascular or cerebrovascular diseases, deemed unsuitable for study participation by the investigator; 7. Laboratory abnormalities of clinical significance, deemed unsuitable for study participation by the investigator, including: (1) ALT and/or AST > 2 times the upper limit of normal (ULN); (2) TBIL >= 1.5 times the upper limit; 8. Pregnant or lactating women, or women planning to become pregnant or lactate during the study period; 9. Inability to complete colonoscopy or catheterization as required, or unable to complete study-related examinations; 10. Participation in other clinical trials within 3 months prior to enrollment; 11. Other health issues deemed unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the number of completely spontaneous bowel movements (CSBM); | — |
Secondary
| Measure | Time frame |
|---|---|
| Colonic Transit Test;Bristol Stool Form Scale (BSFS) score;Number of participants with adverse events (e.g., bloating, infection).;Fecal Water Content and Microbiota Composition;Constipation Symptom Self-Assessment Scale;The frequency of SBM and CSBM; | — |
Countries
China
Contacts
Public ContactJingnan Li
Peking Union Medical College Hospital
Outcome results
None listed