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

NCT ID: NCT06772064

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-15
• Study Completion Date: 2025-12-01

Brief Summary

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.

Detailed Description

The study enrolled subjects who primarily complained of abdominal bloating, and underwent breath testing, along with healthy volunteers. Study participants were required to meet the inclusion criteria, not meet the exclusion criteria, and sign an informed consent form. After enrollment, they completed a case report form. Basic demographic information of the study participants, results of routine laboratory tests, clinical characteristics related to symptoms, results and values of breath test, and other data were recorded. Patients were required to provide stool samples and conduct psychiatric questionnaire scoring, and the healthy control group was also required to provide stool samples. After enrollment, patients took rifaximin dry suspension at a dosage of 0.4 g twice a day for two weeks, recording medication intake and adverse reactions through a diary card during the medication period. Two weeks after the end of the medication, the diary cards and medication packaging were collected, and the case report forms were supplemented. Stool samples were taken again, and anxiety and depression scale scores were recorded to document changes in clinical symptoms. One month after the end of the medication, patients were required to undergo a repeat breath test, and follow-ups for changes in abdominal bloating symptoms were conducted three and six months after the end of the medication .

Conditions

SIBO

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Healthy group

The healthy group met the inclusion and exclusion criteria, and stool samples were retained for microflora analysis as control.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Patient group

Patients were required to collect stool samples and score a psychopsychological questionnaire. After enrollment, patients were given Rifaximin dry suspension 0.4g bid for 2 weeks. During the medication period, patients' drug consumption and adverse reactions were recorded through diary cards. After 2 weeks of medication, diary cards and outer packaging of drugs were collected, and case report forms were supplemented. Stool samples were collected again, anxiety and depression scale scores were performed, and clinical symptom changes were recorded. The breath test was reviewed 1 month after the end of the medication, and follow-up was conducted 3 months and 6 months after the end of the medication.

Group Type: EXPERIMENTAL

Rifaximin (drug)

Intervention Type: DRUG

Rifaximin 0.4g bid for 2 weeks

Interventions

Rifaximin (drug)

Rifaximin 0.4g bid for 2 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age between 18 and 70 years, both genders included.

2. No special gastrointestinal discomfort such as bloating or abdominal pain, regular bowel movements, and normal stool characteristics.

3. Negative hydrogen/methane breath test.

1. Age between 18 and 70 years, both genders included.

2. Chief complaints of abdominal bloating and/or distension; outpatients with abdominal bloating and/or distension more prominent than other symptoms.

3. Positive hydrogen/methane breath test.

Exclusion Criteria

1. Pregnant or lactating women.

2. History of gastrointestinal malignancy or gastrointestinal surgery.

3. Past diagnosis or suspicion of lactose intolerance.

4. Confirmed extra-digestive system diseases such as urinary system (chronic kidney disease, etc.), immune system (scleroderma, etc.), nervous system (Parkinson's, etc.), endocrine system (diabetes, etc.).

5. Abnormalities in professional anxiety and depression symptom rating scales.

6. Use of antibiotics, probiotics within two weeks, endoscopic examination, or use of prokinetics, secretagogues, antifoaming agents, antispasmodics, opioids, antidepressants within one week.

7. Those who cannot or are unwilling to sign an informed consent form.

Patient Group:

1. Pregnant or lactating women.

2. History of gastrointestinal malignancy or gastrointestinal surgery.

3. Past diagnosis or suspicion of lactose intolerance.

4. Confirmed extra-digestive system diseases such as urinary system (chronic kidney disease, etc.), immune system (scleroderma, etc.), nervous system (Parkinson's, etc.), endocrine system (diabetes, etc.).

5. Moderate to severe abnormalities in professional anxiety and depression symptom rating scales.

6. Use of antibiotics, probiotics within two weeks, endoscopic examination, or use of prokinetics, secretagogues, antifoaming agents, antispasmodics, opioids, antidepressants within one week.

7. Those who cannot or are unwilling to sign an informed consent form.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Xiuli Zuo

OTHER

Sponsor Role: lead

Responsible Party

Xiuli Zuo

Professor, Director of gastroenterology department of Qilu hospital.

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiuli Zuo, MD,PhD

Role: CONTACT

zuoxiuli@sdu.edu.cn

15588818685

Facility Contacts

Xiuli Zuo, MD,PhD

Role: primary

zuoxiuli@sdu.edu.cn

+8615588818685

Other Identifiers

KYLL-202408-061-1

Identifier Type: -

Identifier Source: org_study_id