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The Efficacy of Probiotics as an Adjunct to Treatment of SIBO With Rifaximin

NCT06223685 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2025-12-04

No results posted yet for this study

Summary

The goal of this clinical trial is to test the effectiveness of probiotic bacterial supplements as an additional therapeutic modality in patients with small intestine bacterial overgrowth who receive oral antibiotic treatment (rifaximin)

The main questions it aims to answer are:

1 To evaluate the effectiveness of a dietary intervention using pro-biotic bacterial strains as an adjunct to treatment of SIBO with rifaximin.

2\. Evaluation of ultrasonographic imaging of mesenteric lymph nodes in patients with SIBO.

3\. Evaluation of the effect of rifaximin treatment and dietary intervention on non-alcoholic fatty liver disease activity parameters in patients with coexisting NAFLD and SIBO.

According to the study schedule, a total of 3 visits will be made within 3 months. Visit 1, after 6 weeks Visit 2 and after another 6 weeks, Visit 3. Patients will also be invited to a follow-up Visit 4, three months after completing participation in the study.

All study participants will receive treatment recommendations for SIBO in accordance with standard practice - a 14-day antibiotic treatment with Rifaximin.

In addition, a randomly selected half of the study participants will receive probiotic therapy and half a placebo.

* An ultrasound examination of the mesenteric root lymph nodes will be performed at each visit,
* followed by a lier steatosis/fibrosis assessment using SWE elastography or FibroScan.
* Blood sampling is required on each visit. All study participants will receive detailed guidelines during dietary consultations at each visit for the use of a low FODMAP diet.
* Each participant will receive a paper diary on how to assess the severity of bloating and evaluate bowel movements, which must be filled out daily.
* In addition, at the visits the patient will be asked to fill out an additional questionnaire on other gastrointestinal complaints and mental health.

Conditions

  • Irritable Bowel Syndrome
  • Small Intestinal Bacterial Overgrowth
  • SIBO

Interventions

DRUG

Rifaximin (Xifaxan) 1200mg/day

Dosage 3x2 tablets per day 14 days

DIETARY_SUPPLEMENT

Probiotic

2x1 capsules per day. 12 weeks.

DRUG

XIFAXAN® (Rifaximin) 1600mg/day

Dosage 4x2 tablets per day 14 days

Sponsors & Collaborators

  • Pomeranian Medical University Szczecin

    lead OTHER

Principal Investigators

  • Katarzyna Kozlowska-Petriczko, MD, PhD · Pomeranian Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2024-08-01
Completion
2025-08-30

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06223685 on ClinicalTrials.gov