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

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

Status
Not yet recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06518850
Enrollment
30
Registered
2024-07-24
Start date
2024-08-01
Completion date
2025-12-31
Last updated
2024-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small Intestine Bacterial Overgrowth

Keywords

small intestine bacterial overgrowth, oral cecum transit time, abdominal distention

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.

Interventions

DRUGRifaximin

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.

Sponsors

Navy General Hospital, Beijing
CollaboratorOTHER
Air Force Military Medical University, China
CollaboratorOTHER
Beijing Tongren Hospital
CollaboratorOTHER
Beijing Friendship Hospital
CollaboratorOTHER
Beijing Chao Yang Hospital
CollaboratorOTHER
Beijing Tiantan Hospital
CollaboratorOTHER
The Luhe Teaching Hospital of the Capital Medical University
CollaboratorOTHER
China-Japan Friendship Hospital
CollaboratorOTHER
Beijing Aerospace General Hospital
CollaboratorOTHER
Beijing Jishuitan Hospital
CollaboratorOTHER
Peking University Third Hospital
CollaboratorOTHER
Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Part 2 Negative conversion rate of small intestinal bacterial overgrowth and oral cecum transit time2 weeks1. 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 Positive rate of small intestinal bacterial overgrowth1 dayPositive rate of small intestinal bacterial overgrowth in organic and functional abdominal distension
Part 1 Abnormal rate of oral cecum transit time1 dayAbnormal rate of oral cecum transit time in organic and functional abdominal distension
Part 2 Effective rate of abdominal distension2 weeksTotal 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

Contacts

Primary ContactJing-Nan Li, MD,Ph.D
Jing-NanLilijn2008@126.com13601235229

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026