Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 1:10 AM
Study NCT ID:
NCT07426705
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-23
First Post:
2026-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Multispecies Probiotic Supplementation on the Efficacy of Rifaximin α Therapy in Patients With Small Intestinal Bacterial Overgrowth (SIBO): a Randomized Placebo-controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078262', 'term': 'Rifaximin'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}], 'ancestors': [{'id': 'D012294', 'term': 'Rifamycins'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D047029', 'term': 'Lactams, Macrocyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, double-blind, placebo-controlled, parallel-group design.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-16', 'studyFirstSubmitDate': '2026-02-16', 'studyFirstSubmitQcDate': '2026-02-16', 'lastUpdatePostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SIBO eradication rate', 'timeFrame': '4 weeks', 'description': 'Proportion of participants with eradicated small intestinal bacterial overgrowth (SIBO), defined as a negative hydrogen breath test, assessed 4 weeks after treatment initiation (rifaximin for 14 days plus probiotic for 4 weeks).'}], 'secondaryOutcomes': [{'measure': 'SIBO recurrence rate after completion of probiotic therapy', 'timeFrame': '10 weeks', 'description': 'Proportion of participants with recurrent SIBO, defined as a positive hydrogen breath test, assessed 4 weeks after completion of 6 weeks of probiotic supplementation following rifaximin treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SIBO', 'IBS', 'probiotic'], 'conditions': ['Small Intestinal Bacterial Overgrowth Syndrome (SIBO)', 'IBS']}, 'descriptionModule': {'briefSummary': 'Small intestinal bacterial overgrowth (SIBO) is a common condition associated with gastrointestinal symptoms such as bloating, abdominal pain, diarrhea, and constipation, particularly in patients with irritable bowel syndrome. Antibiotic therapy with rifaximin is commonly used, but relapse rates remain high.\n\nThis randomized, placebo-controlled clinical trial aims to evaluate whether supplementation with a multispecies probiotic containing Enterococcus faecium and Bacillus subtilis improves the effectiveness of rifaximin therapy in adult patients with SIBO.\n\nParticipants will be randomly assigned to receive either rifaximin plus the probiotic or rifaximin plus placebo. Clinical assessments will include hydrogen breath testing and evaluation of gastrointestinal symptoms using standardized questionnaires at baseline and during follow-up visits.\n\nThe study is being conducted at a single academic medical center in Poland and is sponsored by Państwowy Instytut Medyczny MSWiA. The probiotic and rifaximin are provided by Urgo.\n\nThe results of this study may help determine whether probiotic supplementation can improve treatment outcomes and reduce recurrence of SIBO.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥18 years.\n* Meets Rome IV criteria for irritable bowel syndrome.\n* Written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Lack of cooperation with investigators.\n* Age \\>75 years.\n* Need for modification of gastrointestinal treatment during the study.\n* Use of antibiotics within 4 weeks before screening.\n* Use of probiotics within 7 days before screening.\n* Endoscopic examination within 6 weeks before screening or during the study without investigator approval.\n* History of abdominal surgery.\n* Crohn's disease, ulcerative colitis, microscopic colitis, celiac disease, cystic fibrosis, chronic pancreatitis, liver cirrhosis, or end-stage renal disease.\n* Low FODMAP diet within 4 weeks before screening.\n* Pregnancy or breastfeeding.\n* Lactulose intolerance."}, 'identificationModule': {'nctId': 'NCT07426705', 'acronym': 'SIBO-Probiotic', 'briefTitle': 'Effect of Multispecies Probiotic Supplementation on the Efficacy of Rifaximin α Therapy in Patients With Small Intestinal Bacterial Overgrowth (SIBO): a Randomized Placebo-controlled Trial', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Państwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i Administracji'}, 'officialTitle': 'Effect of Enterococcus Faecium and Bacillus Subtilis-Containing Multispecies Probiotic Supplementation on the Therapeutic Efficacy of Rifaximin α in Patients With Small Intestinal Bacterial Overgrowth (SIBO): a Prospective, Randomized, Placebo-controlled Trial', 'orgStudyIdInfo': {'id': '34/BK/2025'}, 'secondaryIdInfos': [{'id': '34/BK/2025', 'type': 'OTHER', 'domain': 'PIM MSWiA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotic Group', 'description': 'Participants will receive rifaximin followed by the probiotic preparation according to the study protocol.', 'interventionNames': ['Dietary Supplement: Probiotic preparation', 'Drug: Rifaximin (drug)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'Participants will receive rifaximin followed by placebo according to the study protocol.', 'interventionNames': ['Other: Placebo', 'Drug: Rifaximin (drug)']}], 'interventions': [{'name': 'Probiotic preparation', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral probiotic preparation administered once daily for 6 weeks following completion of antibiotic treatment for small intestinal bacterial overgrowth (SIBO). The product contains a defined combination of bacterial strains and is intended to support restoration of gut microbiota and reduce recurrence of SIBO.', 'armGroupLabels': ['Probiotic Group']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Matching oral placebo capsule administered once daily for 6 weeks following completion of antibiotic treatment for small intestinal bacterial overgrowth (SIBO). The placebo is identical in appearance, taste, and packaging to the probiotic product but contains no live microorganisms.', 'armGroupLabels': ['Placebo Group']}, {'name': 'Rifaximin (drug)', 'type': 'DRUG', 'description': 'Rifaximin is administered to all participants as background standard therapy for SIBO at a dose of 1600 mg per day orally for 14 days. The randomized comparison concerns adjunctive probiotic versus placebo.', 'armGroupLabels': ['Placebo Group', 'Probiotic Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Paulina PANUFNIK', 'role': 'CONTACT', 'email': 'paulina.panufnik@pimmswia.gov.pl', 'phone': '477221420'}, {'name': 'Aleksandra Perdek', 'role': 'CONTACT', 'phone': '477221242'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Państwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i Administracji', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'URGO Poland', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}