CompletedNot Applicable

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

Poland129 participantsStarted 2023-04-01

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * positive hydrogen OR methane breath test * SIBO symptoms seen as: moderate or severe bloating for at least 50% of days in the past 3 months if hydrogen test (+) OR constipation (\< 3 bowel movements/week) in the past 3 months if methane test (+) Exclusion Criteria: * age \<18 * age \>70, * current proton pump inhibitor therapy, * antibiotic therapy in the past 3 months, * probiotic therapy in the past 2 weeks, * daily intake of \>30 g of ethanol for men * daily intake of \>20 g of ethanol for women, * hepatitis B or C virus infection, * other liver disease, * celiac disease, * severe chronic disease (m.e.g. chronic kidney disease, congestive heart failure, cancer, liver failure), * current symptoms of acute infection, * pregnancy, * vegan diet or following non-recommended diets such as ketogenic, * patients with very high physical activity (\> 5 x week of 100 min of strength training).

What they're measuring

Change in bloating on Visual Analog Score

Timeframe: 12 weeks

Change in bowel movements in a bowel-movement diary

Timeframe: 12 weeks

Trial details

NCT IDNCT06223685

SponsorPomeranian Medical University Szczecin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-01