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

Phase 4Not Yet RecruitingNCT07426705

Państwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i Administracji100 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

100

Conditions

Small Intestinal Bacterial Overgrowth Syndrome (SIBO)IBS

Interventions

Probiotic preparationDIETARY_SUPPLEMENT

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.

PlaceboOTHER

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.

Rifaximin (drug)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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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).

Time frame: 4 weeks

Secondary Outcomes

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.

Time frame: 10 weeks