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

NCT06772064 | Recruiting

• 1 other identifier: KYLL-202408-061-1
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

SIBO

Keywords

SIBO; Abdominal bloating; Rifaximin

Outcome Measures

Primary Outcomes (1)

• Negative conversion rate of hydrogen and methane breath testing

  Negative conversion rate of hydrogen and methane breath testing in patients treated with rifaximin.

  Up to 1 week after hydrogen and methane breath testing

Secondary Outcomes (1)

• Symptom remission rate

  During the administration period, 1 month after the end of the administration, 3 months and 6 months of follow-up

Other Outcomes (3)

• Changes of fecal flora (16 S Sequence Analysis).

  Immediately collect fecal before and after taking rifaximin.

• The difference of fecal flora between patients and normal population (16 S Sequence Analysis).

  Test immediately after collection of stool sample.

• Psychopsychological questionnaire score

  Collect the questionnaire and rate it immediately.

Study Arms (2)

Healthy group

NO INTERVENTION

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

Patient group

EXPERIMENTAL

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.

Drug: Rifaximin (drug)

Interventions

Rifaximin (drug) DRUG

Rifaximin 0.4g bid for 2 weeks

Patient group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 70 years, both genders included.
• No special gastrointestinal discomfort such as bloating or abdominal pain, regular bowel movements, and normal stool characteristics.
• Negative hydrogen/methane breath test.

You may not qualify if:

• Pregnant or lactating women.
• History of gastrointestinal malignancy or gastrointestinal surgery.
• Past diagnosis or suspicion of lactose intolerance.
• 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.).
• Abnormalities in professional anxiety and depression symptom rating scales.
• Use of antibiotics, probiotics within two weeks, endoscopic examination, or use of prokinetics, secretagogues, antifoaming agents, antispasmodics, opioids, antidepressants within one week.
• Those who cannot or are unwilling to sign an informed consent form.
• Patient Group:
• Age between 18 and 70 years, both genders included.
• Chief complaints of abdominal bloating and/or distension; outpatients with abdominal bloating and/or distension more prominent than other symptoms.
• Positive hydrogen/methane breath test.
• Pregnant or lactating women.
• History of gastrointestinal malignancy or gastrointestinal surgery.
• Past diagnosis or suspicion of lactose intolerance.
• 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.).

Sponsors & Collaborators

• Xiuli Zuo: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Interventions

Rifaximin; Pharmaceutical Preparations

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Central Study Contacts

Xiuli Zuo, MD,PhD

CONTACT

15588818685; zuoxiuli@sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Director of gastroenterology department of Qilu hospital.

Study Record Dates

• First Submitted: December 22, 2024
• First Posted: January 13, 2025
• Study Start: April 15, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)