Investigation of the mechanism of action of Bifidobacterium bifidum G9-1 in improving symptoms of chronic constipation

Kobayashi Takashi0 个研究点目标入组 35 人开始时间: 2023年4月1日最近更新: 2023年10月17日

适应症

试验速览

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•1) Patients diagnosed with chronic constipation by ROME IV or previously diagnosed with chronic constipation by ROME IV and under treatment
•2) Men and women between the ages of 18 and 85 at the time consent is obtained
•3) Patients who can provide written consent for participation in this study from the subject him/herself
•4) Patients with a JPAC-QOL overall score of 1 or higher

•1) Patients with or suspected of having abnormal rectoanal function
•2) Patients with organic abnormalities that cause constipation noted on colonoscopy within 5 years
•3) Patients with serious complications (liver disease: Child-Pugh classification C or higher, renal disease: CKD stage 4 or higher, cardiac disease: NYHA classification III or higher, metabolic disease: HbA1c 10% or higher, malignant tumor diagnosed within the past 5 years [Excluded if fully cured], etc.)
•4) Patients with pre-existing or complicated celiac disease or inflammatory bowel disease
•5) Patients with serious psychiatric complications
•6) Patients with alcohol and drug abuse
•7) Patients with a history of allergy to the study drug
•8) Patients newly treated for constipation within 2 weeks prior to enrollment
•9) Patients whose dosage and administration of ongoing medications for constipation was adjusted within 2 weeks prior to enrollment
•10) Patients taking probiotics other than protocol therapy (e.g.over-the-counter intestinal medications, etc.)
•11) Patients newly treated with opioids or sleeping pills within 2 weeks prior to enrollment
•12) Patients entering a clinical study with intervention within 4 weeks
•13) Patients with pre-existing or complicated Parkinson's disease
•14) Patients deemed inappropriate by a physician

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