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:
Państwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i Administracji
Organization:
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SIBO-Probiotic
Brief Summary:
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.
This 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.
Participants 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.
The 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.
The results of this study may help determine whether probiotic supplementation can improve treatment outcomes and reduce recurrence of SIBO.
This 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.
Participants 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.
The 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.
The results of this study may help determine whether probiotic supplementation can improve treatment outcomes and reduce recurrence of SIBO.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 34/BK/2025 | OTHER | PIM MSWiA | View |