medical device clinical trial to evaluate the safety and efficacy of BAMK-M100 to help treat constipation in patients with chronic constipation

BMS0 个研究点目标入组 15 人开始时间: 待定最近更新: 2021年7月12日

适应症

试验速览

暂无简介。

•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.

发起方

BMS