Clinical trial NCT06518850: Study of Clinical Features and Efficacy of Small Intestinal Bacterial Overgrowth in Patients With Abdominal Distension
Official title: A Multicentre Study of Clinical Features and Efficacy of Small Intestinal Bacterial Overgrowth in Abdominal Distension Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Small Intestine Bacterial Overgrowth
Keywords: small intestine bacterial overgrowth
oral cecum transit time
abdominal distention
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Navy General Hospital, Beijing
name: Air Force Military Medical University, China
name: Beijing Tongren Hospital
name: Beijing Friendship Hospital
name: Beijing Chao Yang Hospital
name: Beijing Tiantan Hospital
name: The Luhe Teaching Hospital of the Capital Medical University
name: China-Japan Friendship Hospital
name: Beijing Aerospace General Hospital
name: Beijing Jishuitan Hospital
name: Peking University Third Hospital
First posted: 2024-07-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion criteria:

Part 1 Clinical characteristics of small intestinal bacterial overgrowth in patients with abdominal distension of different etiologies

1. Age 18-60 years old and gender;
2. 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

1. Patients with functional abdominal distension and small intestinal bacterial overgrowth were selected in Part 1;
2. No drug contraindications.

Exclusion criteria:

Part 1 Clinical characteristics of small intestinal bacterial overgrowth in patients with abdominal distension of different etiologies

1. Preparation for pregnancy, pregnancy, breastfeeding women, or overall poor compliance, or other conditions that the investigator believes need to be excluded;
2. History of malignant tumors, history of abdominal surgeries;
3. Food intolerance, confirmed or suspected lactose intolerance;
4. 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;
5. 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

1. Antibiotics and microecological preparations should be used within two weeks;
2. Use motility enhancers, secretagogues, antifoaming agents, spasmolytics, opioids, antidepressants and other medications within a week.

Primary outcomes:
measure: Part 1 Positive rate of small intestinal bacterial overgrowth
timeFrame: 1 day
measure: Part 1 Abnormal rate of oral cecum transit time
timeFrame: 1 day
measure: Part 2 Effective rate of abdominal distension
timeFrame: 2 weeks
measure: Part 2 Negative conversion rate of small intestinal bacterial overgrowth and oral cecum transit time
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Peking Union Medical College Hospital
name: Jing-Nan Li, MD,Ph.D
role: PRINCIPAL_INVESTIGATOR
References: