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

NCT06223685 | Completed

• 1 other identifier: KB-006/15/2023
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

SIBO; rifaximin; probiotics; intestinal permeability

Outcome Measures

Primary Outcomes (2)

• Change in bloating on Visual Analog Score

  Visual Analog Score (range 0-10, the lower the better) reduction in bloating by 50% in patients with a baseline positive hydrogen test

  12 weeks

• Change in bowel movements in a bowel-movement diary

  increase in bowel frequency by 1/week in patients with a baseline positive methane test

  12 weeks

Secondary Outcomes (22)

• The number of patients with a negative hydrogen test

  12 weeks

• The number of patients with a negative methane test

  12 weeks

• Change in subjective symptoms on Visual Analog Score

  12 weeks

• Change in subjective symptoms on Gastrointestinal Symptom Rating

  12 weeks

• Change in patient-reported stool quality by Bristol Stool Chart

  12 weeks

Study Arms (5)

Probiotic+Rifaximin 1200mg/day

EXPERIMENTAL

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)

Drug: Rifaximin (Xifaxan) 1200mg/day; Dietary Supplement: Probiotic

Placebo+Rifaximin 1600mg/day

PLACEBO COMPARATOR

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)

Drug: XIFAXAN® (Rifaximin) 1600mg/day

Control group

NO INTERVENTION

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/day

EXPERIMENTAL

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)

Dietary Supplement: Probiotic; Drug: XIFAXAN® (Rifaximin) 1600mg/day

Placebo+Rifaximin 1200mg/day

PLACEBO COMPARATOR

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)

Drug: Rifaximin (Xifaxan) 1200mg/day

Interventions

Rifaximin (Xifaxan) 1200mg/day DRUG

Dosage 3x2 tablets per day 14 days

Also known as: Xifaxan

Placebo+Rifaximin 1200mg/day; Probiotic+Rifaximin 1200mg/day

Probiotic DIETARY_SUPPLEMENT

2x1 capsules per day. 12 weeks.

Probiotic + Rifaximin 1600mg/day; Probiotic+Rifaximin 1200mg/day

XIFAXAN® (Rifaximin) 1600mg/day DRUG

Dosage 4x2 tablets per day 14 days

Placebo+Rifaximin 1600mg/day; Probiotic + Rifaximin 1600mg/day

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 (+)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pomeranian Medical University Szczecin: lead

Study Sites (1)

Sonomed CENTRUM MEDYCZNE

Szczecin, West Pomeranian Voivodeship, 71-032, Poland

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Rifaximin; Probiotics

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Katarzyna Kozlowska-Petriczko, MD, PhD

  Pomeranian Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective randomized, placebo-controlled, double-blinded study of 100 patients with hydrogen-methane breath test-confirmed small intestinal bacterial overgrowth (SIBO) and symptoms, to evaluate the efficacy of a dietary intervention using probiotic bacterial strains as adjunctive therapy to rifaximin. Half of patients included in the study according to the standard of therapeutic management of SIBO will receive a prescription for rifaximin at a dose of 1200 mg/d for 14 days (Xifaxan 200 mg, 3 op. of 28 tablets, DS. 3 x 400mg) and the other half will receive a prescription for rifaximin at a dose of 1600 mg/d for 14 days (Xifaxan 200 mg, 4 op. of 28 tablets, DS. 4 x 400mg) 50 patients will be randomly assigned to an arm receiving a 4enteric probotic, while 50 patients will receive capsules that will have an identical shell to the probiotic, but will contain only potato starch.

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: January 25, 2024
• Study Start: April 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 30, 2025
• Last Updated: December 4, 2025

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)