A Double-Blinded, Randomized, Placebo-controlled trial of multi strain probiotics capsule (Bifidobacterium long BB536, Lactobacillus acidophilus NCFM and Lactobacillus gasseri LAC343) on clinical symptoms and intestinal permeability in functional abdominal bloating and distension.

Berlin Pharmaceutical Industry Co., Ltd.0 个研究点目标入组 52 人开始时间: 2022年3月23日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1.) 18-75 year old patients with a diagnosis of functional abdominal bloating and distension according to ROME IV criteria
•2.) Functional abdominal bloating and distension symptoms are not improved after food-induced bloating and distension avoidance and restriction for 2 weeks

•1.) Previous abdominal surgery except appendectomy or cholecystectomy without complication
•2.) Abnormal abdominal/pelvic structural such as abdominal infection, inflammatory bowel disease, gut obstruction, abdominal cancer, Celiac disease, lactose intolerance, fructose intolerance or pelvic floor dysfunction.
•3.) Patients with diabetes, kidney disease, hypothyroidism, neurodegenerative disease, connective tissue disease, psychiatric problem, uncontrolled underlying disease
•4.) Patients with NSAIDs, corticosteroids, antispasmodic, anti-flatulence, pro kinetic, tricyclic antidepressant, antibiotics, probiotics or opioid before inclusion in the study for 2 weeks
•5.) Usual smoking or alcohol drinking
•6.) Pregnant or breast feeding women
•7.) Patients receive chemotherapy
•8.) Patients with absolute neutrophil count less than 1000 mm3
•9.) HIV infection with CD4 count less than 200 cell/mm3
•10.) Allergy to one of the product ingredients or placebo

发起方

Berlin Pharmaceutical Industry Co., Ltd.