A Phase 4 interventional study of Saccharomyces boulardii sachets and Rifaximin (Xifaxan) in Small Intestinal Bacterial Overgrowth Syndrome (SIBO), sponsored by Shandong University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Shandong University · Phase 4, Interventional, and Treatment
This multicenter randomized controlled study aims to systematically evaluate the efficacy and safety of Saccharomyces boulardii sachets versus rifaximin in the treatment of small intestinal bacterial overgrowth (SIBO), with a focus on symptom relief and the impacts of anxiety-depressive factors on the treatment of abdominal distension and diarrhea in SIBO patients. The findings will offer a new non-antibiotic therapeutic option for SIBO, especially for patients with antibiotic resistance or those requiring long-term management, and lay a theoretical foundation for the clinical application of intestinal microecological regulators.
11 studies on the registry are indexed under Blind Loop Syndrome; 4 are open to participants now.
This study's planned enrollment of 222 is above the median of 48 across 10 interventional studies indexed under Blind Loop Syndrome.
Browse Blind Loop Syndrome studies →Shandong University is the lead sponsor of 292 studies on the registry; 60 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects receive Saccharomyces boulardii sachets 0.5 g twice daily orally for 2 weeks
Drug: Saccharomyces boulardii sachets
Subjects receive rifaximin 0.4 g twice daily orally for 2 weeks
Drug: Rifaximin (Xifaxan)
0.5 g, orally, twice daily for 2 weeks
0.4 g, orally, twice daily for 2 weeks
Clinical Effective Rate After Intervention and 1 Month Post-treatment
Proportion of participants achieving clinical effectiveness, defined as complete relief, major relief or partial relief of abdominal distension and diarrhea symptoms. Clinical effective rate = (number of participants with complete relief + major relief + partial relief) / total number of participants × 100%
Time frame: End of 2-week treatment; 1 month after completion of treatment
Symptom Relief Rate After Intervention and 1 Month Post-treatment
Symptom relief rate calculated as \[(pre-treatment total symptom score - post-treatment total symptom score) / pre-treatment total symptom score\] ×100%. Symptom scores for abdominal distension and diarrhea are assessed by 4-level scoring systems
Time frame: End of 2-week treatment; 1 month after completion of treatment
Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Total Score
GSRS is a 7-point Likert-type scale evaluating 15 gastrointestinal symptoms; total score ranges from 15 to 105, higher scores indicate more severe gastrointestinal symptoms. Change = post-treatment score minus baseline score
Time frame: Baseline, end of 2-week treatment, 1 month after completion of treatment
Incidence of Adverse Events
Proportion of participants experiencing adverse events during the 2-week treatment period. Adverse events are graded per Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
Time frame: From first study drug administration up to 60 days after last study drug dose
Participant Treatment Adherence Rate
Treatment adherence defined as actual study drug consumption accounting for 80%-120% of prescribed dose. Adherence rate = number of participants with adequate adherence / total evaluable participants ×100%
Time frame: Throughout the 2-week treatment period
Proportion of Participants With Comorbid Anxiety and Depression
Proportion of SIBO participants with abnormal anxiety-depression scores. Assessments include Self-rating Anxiety Scale (SAS), Self-rating Depression Scale (SDS), Hamilton Anxiety Rating Scale (HAMA), and Hamilton Depression Rating Scale (HAMD)
Time frame: Baseline, 1 month after completion of treatment
Correlation Between Anxiety-depression Scores and Degree of Symptom Relief
Correlation analysis between baseline anxiety-depression scale scores and symptom relief rate after treatment
Time frame: Baseline, 1 month after completion of treatment
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Nov 2027, 14 months later.
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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