The Efficacy of Probiotics as an Adjunct to Treatment of SIBO With Rifaximin
Key facts
- Who runs it
- Pomeranian Medical University Szczecin
- Where
- Poland1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 129 people enrolled
- Started
- 1 Apr 2023
- Ended
- 30 Aug 2025
- Type of study
- Interventional, 5 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Rifaximin (Xifaxan) 1200mg/day
- Probiotic
- XIFAXAN® (Rifaximin) 1600mg/day
- Record updated
- 4 December 2025
Who can take part
- Age
- 18 years to 70 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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 (+)
Who cannot take part
- current proton pump inhibitor therapy,
- antibiotic therapy in the past 3 months,
- probiotic therapy in the past 2 weeks,
- 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,
- age <18
- age >70,
- daily intake of >30 g of ethanol for men
- daily intake of >20 g of ethanol for women,
- 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)
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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)
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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.
The 5 groups in the trial
- Probiotic+Rifaximin 1200mg/dayTreatment being tested
Dosage 2x1 capsule/day. 12 weeks Probiotic, which will contain a combination of four freeze-dried strains of probiotic bacteria in DRcaps enteral capsulesTM . These are capsules that protect the probiotics from the effects of hydrochloric acid in the stomach, as they only dissolve in the intestines. The tested composition of probiotics is on sale in Poland, Italy, Taiwan, among other countries. It has a positive recommendation of the Institute "Pomnik-Center for Children's Health" No. 16/DJW/2022. (Lactococcus lactis Rosell® - 1058, Lactobacillus casei Rosell® - 215, Lactobacillus helvetius Rosell® - 52, Bifidobacterium bifidum Rosell® - 71) AND Rifaximin at a dose of 1200 mg/d for 14 days (Xifaxan 200 mg, 3 op. of 28 tablets, DS. 3 x 400mg)
Treatment: Rifaximin (Xifaxan) 1200mg/day and Probiotic
- Placebo+Rifaximin 1600mg/dayPlacebo, for comparison
Capsules that look identical to the probiotic and contain potato starch and a shell: hydroxypropylmethylcellulose, gellan gum. Dosage 2x1 capsule per day. 12 weeks AND Rifaximin at a dose of 1600 mg/d for 14 days (Xifaxan 200 mg, 4 op. of 28 tablets, DS. 4 x 400mg)
Treatment: XIFAXAN® (Rifaximin) 1600mg/day
- Control groupNo study treatment, for comparison
The control group will consist of healthy subjects (25 subjects) without SIBO (with a negative hydrogen-methane test) and without NAFLD (CAP\<248dB/m, TE\<6.5kPa).
- Probiotic + Rifaximin 1600mg/dayTreatment being tested
Dosage 2x1 capsule/day. 12 weeks Probiotic, which will contain a combination of four freeze-dried strains of probiotic bacteria in DRcaps enteral capsulesTM . These are capsules that protect the probiotics from the effects of hydrochloric acid in the stomach, as they only dissolve in the intestines. The tested composition of probiotics is on sale in Poland, Italy, Taiwan, among other countries. It has a positive recommendation of the Institute "Pomnik-Center for Children's Health" No. 16/DJW/2022. (Lactococcus lactis Rosell® - 1058, Lactobacillus casei Rosell® - 215, Lactobacillus helvetius Rosell® - 52, Bifidobacterium bifidum Rosell® - 71) AND Rifaximin at a dose of 1600 mg/d for 14 days (Xifaxan 200 mg, 4 op. of 28 tablets, DS. 4 x 400mg)
Treatment: Probiotic and XIFAXAN® (Rifaximin) 1600mg/day
- Placebo+Rifaximin 1200mg/dayPlacebo, for comparison
Capsules that look identical to the probiotic and contain potato starch and a shell: hydroxypropylmethylcellulose, gellan gum. Dosage 2x1 capsule per day. 12 weeks AND Rifaximin at a dose of 1200 mg/d for 14 days (Xifaxan 200 mg, 3 op. of 28 tablets, DS. 3 x 400mg)
Treatment: Rifaximin (Xifaxan) 1200mg/day
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Randomized, Double-blind, Placebo-Controlled Study on Efficacy of a Dietary Intervention With Probiotic Bacterial Strains as an Adjunct to Treatment of Small Intestinal Bacterial Overgrowth With Rifaximin
- Record updated
- 4 December 2025