Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
Healthy Volunteers
NCT06772064

Efficacy of Rifaximin in Patients With Small Intestinal Bacterial Overgrowth Presenting With Abdominal Bloating.

Led by Xiuli Zuo · Updated on 2025-05-16

115

Participants Needed

1

Research Sites

32 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Abdominal bloating is a common clinical symptom in the digestive system, with obscure origins and complex mechanisms. Its etiology can be attributed to organic diseases and various Functional Gastrointestinal Disorders (FGIDs). In recent years, the roles of Small Intestinal Bacterial Overgrowth (SIBO), Oral-Cecal Transit Time (OCTT), and gut microbiota dysbiosis in Functional Abdominal Bloating/Distention (FAB/D) have garnered increasing attention. Currently, there is a lack of diagnostic tests and effective treatment measures for patients with bloating. The hydrogen/methane breath test is a safe, economical, and non-invasive examination recommended for diagnosing SIBO. Rifaximin, an antibiotic that acts exclusively in the intestines, has been widely validated for its efficacy in SIBO and in patients with SIBO co-occurring with Irritable Bowel Syndrome (IBS). However, research on the role of SIBO in the production of bloating symptoms and the extent to which rifaximin treatment of SIBO alleviates symptoms in clinical bloating patients is still lacking. This study aims to investigate the efficacy of rifaximin in patients with SIBO who primarily present with bloating. Exploring clinical treatment options for bloating provides a reference for its management. Furthermore, questionnaires on psychiatric symptoms and fecal microbiota analysis for patients with bloating-type SIBO can help clarify the etiology of bloating, offering a basis for the etiological treatment of bloating patients in the next steps.

CONDITIONS

Official Title

Efficacy of Rifaximin in Patients With Small Intestinal Bacterial Overgrowth Presenting With Abdominal Bloating.

Who Can Participate

Age: 18Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 70 years, both genders included
  • Healthy group: no special gastrointestinal symptoms such as bloating or abdominal pain, regular bowel movements, and normal stool
  • Healthy group: negative hydrogen/methane breath test
  • Patient group: chief complaints of abdominal bloating and/or distension, with these symptoms more prominent than others
  • Patient group: positive hydrogen/methane breath test
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Pregnant or lactating women
  • History of gastrointestinal malignancy or gastrointestinal surgery
  • Past diagnosis or suspicion of lactose intolerance
  • Confirmed diseases of urinary, immune, nervous, or endocrine systems such as chronic kidney disease, scleroderma, Parkinson's, or diabetes
  • Moderate to severe abnormalities in anxiety and depression symptom scales
  • Use of antibiotics or probiotics within two weeks prior to enrollment
  • Use of endoscopic examination, prokinetics, secretagogues, antifoaming agents, antispasmodics, opioids, or antidepressants within one week prior to enrollment
  • Unable or unwilling to sign an informed consent form

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Qilu Hospital of Shandong University

Jinan, Shandong, China, 250012

Actively Recruiting

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Research Team

X

Xiuli Zuo, MD,PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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