Small intestinal bacterial overgrowth (SIBO) is a common condition associated with gastrointestinal symptoms such as bloating, abdominal pain, diarrhea, and constipation, particularly in patients with irritable bowel syndrome. Antibiotic therapy with rifaximin is commonly used, but relapse rates remain high.
This randomized, placebo-controlled clinical trial aims to evaluate whether supplementation with a multispecies probiotic containing Enterococcus faecium and Bacillus subtilis improves the effectiveness of rifaximin therapy in adult patients with SIBO.
Participants will be randomly assigned to receive either rifaximin plus the probiotic or rifaximin plus placebo. Clinical assessments will include hydrogen breath testing and evaluation of gastrointestinal symptoms using standardized questionnaires at baseline and during follow-up visits.
The study is being conducted at a single academic medical center in Poland and is sponsored by Państwowy Instytut Medyczny MSWiA. The probiotic and rifaximin are provided by Urgo.
The results of this study may help determine whether probiotic supplementation can improve treatment outcomes and reduce recurrence of SIBO.
Age ≥18 years.
Meets Rome IV criteria for irritable bowel syndrome.
Written informed consent to participate in the study.
Lack of cooperation with investigators.
Age >75 years.
Need for modification of gastrointestinal treatment during the study.
Use of antibiotics within 4 weeks before screening.
Parallel
Probiotic preparation
Dietary supplementOral probiotic preparation administered once daily for 6 weeks following completion of antibiotic treatment for small intestinal bacterial overgrowth (SIBO). The product contains a defined combination of bacterial strains and is intended to support restoration of gut microbiota and reduce recurrence of SIBO.
Placebo
Other interventionMatching oral placebo capsule administered once daily for 6 weeks following completion of antibiotic treatment for small intestinal bacterial overgrowth (SIBO). The placebo is identical in appearance, taste, and packaging to the probiotic product but contains no live microorganisms.
Rifaximin (drug)
DrugRifaximin is administered to all participants as background standard therapy for SIBO at a dose of 1600 mg per day orally for 14 days. The randomized comparison concerns adjunctive probiotic versus placebo.
SIBO eradication rate
Proportion of participants with eradicated small intestinal bacterial overgrowth (SIBO), defined as a negative hydrogen breath test, assessed 4 weeks after treatment initiation (rifaximin for 14 days plus probiotic for 4 weeks).
SIBO recurrence rate after completion of probiotic therapy
Proportion of participants with recurrent SIBO, defined as a positive hydrogen breath test, assessed 4 weeks after completion of 6 weeks of probiotic supplementation following rifaximin treatment.
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Państwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i Administracji
Lead sponsor
URGO Poland
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
