About this trial
Most studies of bloating have focused on functional factors, while data on organic abdominal distention are rare, and studies that combine small intestine bacterial overgrowth and/or oral cecum transit time abnormalities are more urgent to explore. On this basis, patients with functional abdominal distension complicated with small intestine bacterial overgrowth were divided according to whether there was abnormal oral cecum transit time, and given the same treatment plan. The relief effect of abdominal distension, small intestine bacterial overgrowth turning negative and oral cecum transit time recovery were observed, so as to further clarify the cause of abdominal distension patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-60 years old and gender;
The chief complaint is abdominal distension and/or abdominal distension, abdominal distension and/or abdominal distension more prominent than other symptoms.
Patients with functional abdominal distension and small intestinal bacterial overgrowth were selected in Part 1;
No drug contraindications.
Disqualifiers
Preparation for pregnancy, pregnancy, breastfeeding women, or overall poor compliance, or other conditions that the investigator believes need to be excluded;
History of malignant tumors, history of abdominal surgeries;
Food intolerance, confirmed or suspected lactose intolerance;
Diagnosis of urinary system (chronic kidney disease, etc.), immune system (scleroderma, etc.), nervous system (Parkinson's disease, etc.), mental system (depression, etc.) and other diseases outside the digestive system;
Trial design
Parallel
Treatments tested in this trial
Rifaximin
DrugBoth groups were treated with rifaximin for 14 days, during which follow-up records were reported by the subjects in the daily reference case report form. Methane and hydrogen breath tests were repeated 2 weeks after withdrawal.
Treatment groups
Trial outcomes
Primary outcomes
Part 1 Positive rate of small intestinal bacterial overgrowth
Positive rate of small intestinal bacterial overgrowth in organic and functional abdominal distension
Part 1 Abnormal rate of oral cecum transit time
Abnormal rate of oral cecum transit time in organic and functional abdominal distension
Part 2 Effective rate of abdominal distension
Total effective rate (%) = Obvious effective rate (%) + Effective rate (%) 1. Obvious effect: the degree and frequency of abdominal distension score improved, or even completely disappeared, small intestinal bacterial overgrowth negative 2. Effective: the degree and frequency of abdominal distension score improved, small intestinal bacterial overgrowth positive 3. Ineffective: the degree and frequency of abdominal distension score did not improve
Part 2 Negative conversion rate of small intestinal bacterial overgrowth and oral cecum transit time
1. Negative conversion rate of small intestinal bacterial overgrowth (%) =Number of small intestinal bacterial overgrowth negative after treatment/ Number of functional abdominal distention in Part 2\*100% 2. Negative conversion rate of oral cecum transit time (%) =Number of oral cecum transit time normal after treatment/ Number of experimental in Part 2\*100%
Locations
Sponsors and contacts
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Peking Union Medical College Hospital
Lead sponsor
Navy General Hospital, Beijing
Collaborator
Air Force Military Medical University, China
Collaborator
Beijing Tongren Hospital
Collaborator
Beijing Friendship Hospital
Collaborator
Beijing Chao Yang Hospital
Collaborator
Beijing Tiantan Hospital
Collaborator
The Luhe Teaching Hospital of the Capital Medical University
Collaborator
China-Japan Friendship Hospital
Collaborator
Beijing Aerospace General Hospital
Collaborator
Beijing Jishuitan Hospital
Collaborator
Peking University Third Hospital
Collaborator
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