Effect of Multispecies Probiotic Supplementation on the Efficacy of Rifaximin α Therapy in Patients With Small Intestinal Bacterial Overgrowth (SIBO): a Randomized Placebo-controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Probiotic preparation, Placebo, Rifaximin (drug).
- Who it may be relevant to
- Registry conditions: Small Intestinal Bacterial Overgrowth Syndrome (SIBO), IBS. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Enterococcus Faecium and Bacillus Subtilis-Containing Multispecies Probiotic Supplementation on the Therapeutic Efficacy of Rifaximin α in Patients With Small Intestinal Bacterial Overgrowth (SIBO): a Prospective, Randomized, Placebo-controlled Trial
Overview
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.
Interventions
- Dietary supplement Probiotic preparation
Oral 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. - Other Placebo
Matching 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. - Drug Rifaximin (drug)
Rifaximin 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.
Primary outcome measures
- SIBO eradication rate [Time frame: 4 weeks]
Secondary outcome measures (1)
- SIBO recurrence rate after completion of probiotic therapy [Time frame: 10 weeks]
Eligibility criteria
Inclusion criteria
- Age ≥18 years.
- Meets Rome IV criteria for irritable bowel syndrome.
- Written informed consent to participate in the study.
Exclusion criteria
- 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.
- Use of probiotics within 7 days before screening.
- Endoscopic examination within 6 weeks before screening or during the study without investigator approval.
- History of abdominal surgery.
- Crohn's disease, ulcerative colitis, microscopic colitis, celiac disease, cystic fibrosis, chronic pancreatitis, liver cirrhosis, or end-stage renal disease.
- Low FODMAP diet within 4 weeks before screening.
- Pregnancy or breastfeeding.
- Lactulose intolerance.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07426705 · 34/BK/2025 · 34/BK/2025