Status:
NOT_YET_RECRUITING
Study of Clinical Features and Efficacy of Small Intestinal Bacterial Overgrowth in Patients With Abdominal Distension
Lead Sponsor:
Peking Union Medical College Hospital
Collaborating Sponsors:
Navy General Hospital, Beijing
Air Force Military Medical University, China
Conditions:
Small Intestine Bacterial Overgrowth
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
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 transi...
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 overgro...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Part 1 Clinical characteristics of small intestinal bacterial overgrowth in patients with abdominal distension of different etiologies
- 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.
- Part 2 Efficacy observation of functional abdominal distention combined with small intestine bacterial overgrowth
- Patients with functional abdominal distension and small intestinal bacterial overgrowth were selected in Part 1;
- No drug contraindications.
- Exclusion criteria:
- Part 1 Clinical characteristics of small intestinal bacterial overgrowth in patients with abdominal distension of different etiologies
- 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;
- 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.
- Part 2 Efficacy observation of functional abdominal distention combined with small intestine bacterial overgrowth
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06518850
Start Date
August 1 2024
End Date
December 31 2025
Last Update
July 24 2024
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