functional diarrhea
Conditions
Interventions
Experimental group:Pinaverium Bromide + Bacillus subtilis Combined Live Bacteria
Control group:Bacillus subtilis Combined Live Bacteria
Sponsors
Shenzhen Second People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-65 years, any gender; 2. Meets the Rome IV criteria for functional diarrhea: (1) Duration of illness exceeds 6 months; (2) In the past 3 months, more than 75% of bowel movements are loose or watery stools without abdominal pain (Bristol stool types 6-7); (3) Average daily bowel movements >=3 times; 3. Approved by the Ethics Committee of Shenzhen Second People’s Hospital, and informed consent has been signed by the patients; all study subjects are fully informed and have agreed.
Exclusion criteria
Exclusion criteria: 1. Meets the diagnostic criteria for diarrhea-predominant irritable bowel syndrome (IBS-D) (i.e., diarrhea accompanied by abdominal pain, with pain relieved after defecation); 2. Organic gastrointestinal diseases confirmed by endoscopy, imaging, or laboratory tests (such as inflammatory bowel disease, colorectal cancer, celiac disease, etc.); 3. History of major abdominal surgery (excluding appendectomy and cholecystectomy); 4. Use of antibiotics, probiotics, antidiarrheal drugs, antispasmodics, or any medication affecting gastrointestinal motility within 2 weeks prior to enrollment; 5. Severe heart, liver, or kidney dysfunction (ALT/AST > 2 times the upper limit of normal, Cr > 1.5 times the upper limit of normal); Note: This can be clarified by asking patients about a history of liver or kidney dysfunction and any recent physical exams. If the patient clearly states no related history and recent exams show no abnormalities, they may be enrolled. If the patient is unsure, blood tests to assess liver and kidney function should be done before deciding on enrollment; 6. Pregnant or breastfeeding women; 7. Known allergy to the study drugs (pinaverium bromide or Bacillus subtilis and Enterococcus faecium dual live bacteria) or their components.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall symptom relief rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| The average number of bowel movements per day per week;Bristol stool form score;electrointestinogram;life quality score;Self-rating Depression Scale (SDS) score; | — |
Countries
China
Contacts
Public ContactQin Shu
Shenzhen Second People's Hospital
Outcome results
None listed