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

Sponsor
Państwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i Administracji
Study ID
NCT07426705
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • IBS
  • Small Intestinal Bacterial Overgrowth Syndrome (SIBO)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Probiotic preparation — DIETARY_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.
  • Placebo — OTHER
    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.

Study Details

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.

Key Dates

Start date
Feb 15, 2026
Status verified
Feb 2026
Primary completion
Jul 15, 2027
Completion
Jul 15, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Probiotic Group
    Participants will receive rifaximin followed by the probiotic preparation according to the study protocol.
  • Placebo Comparator: Placebo Group
    Participants will receive rifaximin followed by placebo according to the study protocol.

Primary Outcome Measure

SIBO eradication rate [ Time Frame: 4 weeks ]

Central Contacts

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