Effect of multi strain probiotics capsule on clinical symptoms and intestinal permeability in functional abdominal bloating and distension.
- Conditions
- Functional abdominal bloating and distension according to the ROME IV criteria.Bloating, Distension, Probiotics
- Registration Number
- TCTR20220323007
- Lead Sponsor
- Berlin Pharmaceutical Industry Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 52
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical symptom 4 weeks Visual analog scale and Modified GIS rating scale ,Quality of life 4 weeks GIQo
- Secondary Outcome Measures
Name Time Method Intestinal permeability 4 weeks 2 sugar test probe (Lactulose/mannitol ratio),adverse effect at the end of study questionnaire