medical device clinical trial to evaluate the safety and efficacy of BAMK-M100 to help treat constipation in patients with chronic constipatio
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0006315
- Lead Sponsor
- BMS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 15
1) age 20–80 years,
2) body mass index 18–40 kg/m2,
3) constipation symptom profile according to the April 2016 Rome IV guidelines, and
4) agreement to participate in this study. CC was defined as constipation with long-term symptom duration (onset = 6 months previously and currently symptomatic for =3 months) and the presence of more than two self-reported symptom clusters (hard stools, straining, sensation of incomplete evacuation, sensation of anorectal obstruction, need for manual maneuvers to facilitate >25% defecation, and fewer than three spontaneous bowel movements per week).
1) diagnosis by abnormal colonoscopy or abdominal imaging findings within 2 years;
2) constipation related to a previous surgery or other organic disorder, including Parkinson’s disease and paraplegic disorders (stroke, spinal disorders, multiple sclerosis, and hypothyroidism,);
3) history of open abdominal surgery or peritonitis;
4) history of gastric or small bowel surgery; 5) history of gall bladder surgery;
6) cardiovascular, pulmonary, or other endocrinological disorder that might affect study enrollment; and
7) pregnancy or breastfeeding status.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Colon Transit Time
- Secondary Outcome Measures
Name Time Method