Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06518850

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rifaximin

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.

Primary outcomes

  1. Part 1 Positive rate of small intestinal bacterial overgrowth

    Time frame: 1 day

    Positive rate of small intestinal bacterial overgrowth in organic and functional abdominal distension

  2. Part 1 Abnormal rate of oral cecum transit time

    Time frame: 1 day

    Abnormal rate of oral cecum transit time in organic and functional abdominal distension

  3. Part 2 Effective rate of abdominal distension

    Time frame: 2 weeks

    Total effective rate (%) = Obvious effective rate (%) + Effective rate (%)

    • Obvious effect: the degree and frequency of abdominal distension score improved, or even completely disappeared, small intestinal bacterial overgrowth negative
    • Effective: the degree and frequency of abdominal distension score improved, small intestinal bacterial overgrowth positive
    • Ineffective: the degree and frequency of abdominal distension score did not improve
  4. Part 2 Negative conversion rate of small intestinal bacterial overgrowth and oral cecum transit time

    Time frame: 2 weeks

    • 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%
    • Negative conversion rate of oral cecum transit time (%) =Number of oral cecum transit time normal after treatment/ Number of experimental in Part 2*100%

Study contacts

Contact information is provided by the study sponsor or research team.

Jing-Nan Li, MD,Ph.D

CONTACT

[email protected]

13601235229

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 24, 2024
Registry last updated
Jul 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.