Study of Clinical Features and Efficacy of Small Intestinal Bacterial Overgrowth in Patients With… (NCT06518850) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Study of Clinical Features and Efficacy of Small Intestinal Bacterial Overgrowth in Patients With Abdominal Distension
30 participantsStarted 2024-08-01
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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;
✕
What they're measuring
1
Part 1 Positive rate of small intestinal bacterial overgrowth
Timeframe: 1 day
2
Part 1 Abnormal rate of oral cecum transit time
Timeframe: 1 day
3
Part 2 Effective rate of abdominal distension
Timeframe: 2 weeks
4
Part 2 Negative conversion rate of small intestinal bacterial overgrowth and oral cecum transit time
. Antibiotics and microecological preparations should be used within two weeks. Use motility enhancers, secretagogues, antifoaming agents, spasmolytics, opioids, antidepressants and other medications within a week.
✕. Antibiotics and microecological preparations should be used within two weeks;
✕. Use motility enhancers, secretagogues, antifoaming agents, spasmolytics, opioids, antidepressants and other medications within a week.