Study of Clinical Features and Efficacy of Small Intestinal Bacterial Overgrowth in Patients With Abdominal Distension
- Registration Number
- NCT06518850
- Lead Sponsor
- Peking Union Medical College Hospital
- Brief Summary
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.
- Detailed Description
Part 1 Clinical characteristics of small intestinal bacterial overgrowth in patients with abdominal distension of different etiologies The clinical characteristics of small intestine bacterial overgrowth and oral cecum transit time in patients with abdominal distention of different etiology (organic and functional) were studied to lay a foundation for further exploration of treatment of functional abdominal distention.
Part 2 Efficacy observation of functional abdominal distention combined with small intestine bacterial overgrowth To observe the effect of antibiotics on abdominal distension in patients with functional abdominal distension complicated with small intestine bacterial overgrowth, and observe the effect of rifaximin on small intestine bacterial overgrowth and oral cecum transit time, so as to provide new ideas for the diagnosis and treatment of abdominal distension patients.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham Comparator（Normal oral cecum transit time） Rifaximin Normal oral cecum transit time +functional abdominal distention +small intestinal bacterial overgrowth.Rifaximin (0.2g/ time, 4 times/day) was discontinued after 14 days of treatment. Experimental（Abnormal oral cecum transit time） Rifaximin Abnormal oral cecum transit time +functional abdominal distention +small intestinal bacterial overgrowth.Rifaximin (0.2g/ time, 4 times/day) was discontinued after 14 days of treatment.
- Primary Outcome Measures
Name Time Method Part 1 Positive rate of small intestinal bacterial overgrowth 1 day Positive rate of small intestinal bacterial overgrowth in organic and functional abdominal distension
Part 2 Negative conversion rate of small intestinal bacterial overgrowth and oral cecum transit time 2 weeks 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%Part 1 Abnormal rate of oral cecum transit time 1 day Abnormal rate of oral cecum transit time in organic and functional abdominal distension
Part 2 Effective rate of abdominal distension 2 weeks 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
- Secondary Outcome Measures
Name Time Method