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The goal of this clinical trial is to learn whether a multi-strain probiotic can reduce digestive symptoms and improve quality of life in adults with functional dyspepsia. The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic group | Experimental | L. rhamnosus LR110, B. lactis BI040, B. breve BB010, L. paracasei LPC100, L. acidophilus LA120, L. casei LR130, L. plantarum LP140, S. thermophilus ST250, B. longum BL020, B. bifidum BF030 5 billion CFU one time daily for 60 days |
|
| Placebo group | Placebo Comparator | Product with excepients without probiotic bacteria one time daily for 60 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus | Other | 5 billion CFU of lactobacilus ans streptococci once daily for 60 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Gastrointestinal Symptom Rating Scale | 30 and 60 days |
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Inclusion Criteria:
Age 18-65 years
Diagnosis of Functional Dyspepsia based on Rome IV criteria, with symptoms present for at least 3 months, and symptom onset at least 6 months before diagnosis, including:
Moderate to severe symptom severity at baseline, as defined by a validated scale (e.g., NDI or global symptom score)
Normal upper GI endoscopy within the last 12 months (or at screening), excluding structural disease (e.g., peptic ulcer, malignancy)
Negative for H. pylori (either previously treated successfully or tested negative within study screening)
Ability and willingness to provide informed consent and comply with study procedures
Stable medication use, if any, for at least 4 weeks before screening (e.g., PPIs, antidepressants, laxatives)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sergiy Gerasymov, MD, PhD | Contact | +380679375951 | mediana.statistics@gmail.com | |
| Małgorzata Tyx-Dąbkowska | Contact | +48604494452 | mtd@nordicbiotic.com |
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| ID | Term |
|---|---|
| C100843 | Lacteol |
| C008315 | maltodextrin |
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| Maltodextrin (Placebo) | Other | Placebo capsules will be given one a day for 60 days |
|