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

ConditionSIBO
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorXiuli Zuo

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.).

Trial design

Design model

Single group

Treatments tested in this trial

  • Rifaximin (drug)

    Drug

    Rifaximin 0.4g bid for 2 weeks

Treatment groups

115 Participants
are divided into 2 treatment groups
Group A: Healthy groupNo intervention 0 interventions
Group B: Patient groupExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Up to 1 week after hydrogen and methane breath testing

Secondary outcomes

1

Symptom remission rate

Symptom remission rate in patients treated with rifaximin

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

Other outcomes

1

Changes of fecal flora (16 S Sequence Analysis).

Changes of fecal flora before and after rifaximin administration.

Time frame
Immediately collect fecal before and after taking rifaximin.
2

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

Time frame
Test immediately after collection of stool sample.
3

Psychopsychological questionnaire score

Self-rating depression scale (SDS): minimum value: 20; maximum value:100;The dividing line between normal and anxious patients is 50 points, with higher scores indicating more severe anxiety. Self-Rating Anxiety Scale (SAS): minimum value: 20; maximum value:100; In the Chinese population, the dividing line between normal and depressed people is 53 points, with higher scores indicating more severe depression. Hamilton Anxiety Scale (HAMA):minimum value: 0; maximum value:56; The dividing line between normal and anxious patients is 7 points, with higher scores indicating more severe anxiety. Hamilton Depression Scale (HAMD): minimum value: 0; maximum value: 96; the dividing line between normal and depressed people is 8 points, with higher scores indicating more severe depression.

Time frame
Collect the questionnaire and rate it immediately.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xiuli Zuo

Lead sponsor

Shandong University

Sponsor institution