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| Name | Class |
|---|---|
| Masaryk University | OTHER |
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A two-arm, double-blind, randomized, placebo-controlled study investigating the efficacy of a probiotic preparation developed as supportive supplementation of probiotics in patients with reflux.
The objective of this trial is to evaluate the effect of the probiotic dietary supplement on the diversity and composition of the gut microbiome in patients diagnosed with GERD who are on PPI therapy. The study will also monitor changes in the oral microbiome and the impact of probiotic supplementation on patient quality of life and GERD symptoms.
Patients will take the probiotic preparation, 2 tablets twice daily (morning before meals and evening after meals). The experimental phase will last 6 weeks. Patients in the control arm will receive placebo. Supplementation will be discontinued if adverse effects occur.
Oral and rectal swabs will be taken before and after administration of the preparation. Patients will monitor their symptoms using a questionnaire.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic supplement | Active Comparator |
| |
| Placebo group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A probiotic dietary supplement | Dietary Supplement | A probiotic dietary supplement containing a blend of probiotic bacteria from the Lactobacillaceae family, and the genera Streptococcus and Bifidobacterium, selected based on the latest knowledge concerning the use of probiotics in relation to GERD. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of % of patients with dysbiosis in the gastrointestinal tract caused by the disease itself and/or pharmacotherapy - as assessed by using whole-genome sequencing | From enrollment to the end of supplementation at 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change of GERD symptoms assessed by standardized questionnaires - using symptom scores calculated from the data in the questionnaires | From enrollment to the end of supplementation at 6 weeks | |
| Evaluation of safety and tolerability of the preparation - prevalence of patient-reported adverse events as recorded in questionnaires |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vít Navrátil, MUDr, Ph.D. | Contact | +420588445308 | vit.navratil@fnol.cz |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Olomouc | Recruiting | Olomouc | 77900 | Czechia |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 24, 2026 | Apr 28, 2026 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 24, 2026 | Apr 28, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| Placebo | Dietary Supplement | placebo with the same appearance as the probiotic supplement |
|
| From enrollment to the end of supplementation at 6 weeks |
| D004066 | Digestive System Diseases |