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

Launched by POMERANIAN MEDICAL UNIVERSITY SZCZECIN · Jan 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether taking probiotic supplements can help improve the treatment of Small Intestinal Bacterial Overgrowth (SIBO) when used alongside the antibiotic rifaximin. SIBO can cause uncomfortable symptoms like bloating and constipation. In this study, half of the participants will receive probiotics, while the other half will receive a placebo (a non-active treatment). Researchers want to see how effective the probiotics are in reducing SIBO symptoms and whether they can also help with liver health in patients who have both SIBO and non-alcoholic fatty liver disease.

To be eligible for the trial, participants need to be between the ages of 18 and 70 and must have tested positive for SIBO through a breath test. They should also experience moderate to severe bloating or constipation. Throughout the trial, which lasts about three months, participants will have three visits where they will undergo ultrasounds and blood tests, receive dietary guidance, and keep a diary about their symptoms. This study aims to provide new insights into managing SIBO and improving patients' quality of life.

Gender

ALL

Eligibility criteria

• 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).