Study of Clinical Features and Efficacy of Small Intestinal Bacterial Overgrowth in Patients With Abdominal Distension

NCT ID: NCT06518850

Last Updated: 2024-07-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2025-12-31

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.

Conditions

Small Intestine Bacterial Overgrowth

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Sham Comparator（Normal oral cecum transit time）

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.

Group Type: SHAM_COMPARATOR

Rifaximin

Intervention Type: DRUG

Both 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.

Experimental（Abnormal oral cecum transit time）

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.

Group Type: EXPERIMENTAL

Rifaximin

Intervention Type: DRUG

Both 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.

Interventions

Rifaximin

Both 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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Navy General Hospital, Beijing

OTHER

Sponsor Role: collaborator

Air Force Military Medical University, China

OTHER

Sponsor Role: collaborator

Beijing Tongren Hospital

OTHER

Sponsor Role: collaborator

Beijing Friendship Hospital

OTHER

Sponsor Role: collaborator

Beijing Chao Yang Hospital

OTHER

Sponsor Role: collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role: collaborator

The Luhe Teaching Hospital of the Capital Medical University

OTHER

Sponsor Role: collaborator

China-Japan Friendship Hospital

OTHER

Sponsor Role: collaborator

Beijing Aerospace General Hospital

OTHER

Sponsor Role: collaborator

Beijing Jishuitan Hospital

OTHER

Sponsor Role: collaborator

Peking University Third Hospital

OTHER

Sponsor Role: collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jing-Nan Li

Chief physician, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jing-Nan Li, MD,Ph.D

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Central Contacts

Jing-Nan Li, MD,Ph.D

Role: CONTACT

Jing-NanLilijn2008@126.com

13601235229

Other Identifiers

I-23PJ1228

Identifier Type: -

Identifier Source: org_study_id