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The aim of this clinical study is to evaluate the efficacy and tolerability of probiotics on atrial fibrillation recurrence.
Assessment of AF recurrence: Early AF recurrence is defined as relapse into AF within 1 week following successful cardioversion and AF recurrence through the study's 12-week follow-up.
Patients and Methods Design: Prospective, randomized, open label, controlled clinical trial
Patients: A total of 56 AF patients undergoing cardioversion will be randomly enrolled into one of 2 arms:
Groups (1 & 2) will be subjected to cardioversion on admission according to standard protocols and criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Control group | Experimental | 28 AF patients undergoing cardioversion who will receive standard of care |
|
| Experimental: Probiotic group | Experimental | 28 AF patients undergoing cardioversion who will receive the standard of care in addition to Probiotics 25 billion daily orally, after cardioversion for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anticoagulant Therapy | Drug | Drug: The standard of care for AF management directly following cardioversion Include anticoagulant therapy for at least 4 weeks, rate control therapy, rhythm control therapy, or both as per clinical and guideline decisions. |
| Measure | Description | Time Frame |
|---|---|---|
| Atrial Fibrillation Recurrence | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Atrial Fibrillation Recurrence | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah M. Raesah | Contact | +201018585869 | sara.mostafa18@pharma.asu.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University's Hospital | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40575430 | Background | Brar AS, Vemula SL, Yanamaladoddi V, Sodhi S, Hatwal J, Sohal A, Batta A. Impact of gut microbiome on atrial fibrillation: Mechanistic insights and future directions in individualized medicine. World J Cardiol. 2025 Jun 26;17(6):107386. doi: 10.4330/wjc.v17.i6.107386. | |
| 39930552 | Background | Chen J, Wang Y, Wang K, Mei Z, Wang L. Exploring the Axis of Gut Microbiota-Inflammatory Cytokine-Atrial Fibrillation in the Pathogenesis of Atrial Fibrillation. J Cell Mol Med. 2025 Feb;29(3):e70379. doi: 10.1111/jcmm.70379. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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|
| Probiotics capsules | Drug | Probiotics at a of dose 25 billion / 1 capsule will be orally administered daily for 12 weeks |
|
| 36009566 | Background | Drapkina OM, Yafarova AA, Kaburova AN, Kiselev AR. Targeting Gut Microbiota as a Novel Strategy for Prevention and Treatment of Hypertension, Atrial Fibrillation and Heart Failure: Current Knowledge and Future Perspectives. Biomedicines. 2022 Aug 19;10(8):2019. doi: 10.3390/biomedicines10082019. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D019602 |
| Food and Beverages |