Evaluation of Probiotics' Effect on Atrial Fibrillation Recurrence in Patients Undergoing Cardioversion
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Anticoagulant Therapy, Probiotics capsules.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation (AF). Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Probiotics on Atrial Fibrillation Outcome in Patients Undergoing Cardioversion
Overview
The aim of this clinical study is to evaluate the efficacy and tolerability of probiotics on atrial fibrillation recurrence.
Detailed description
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:
1. Group 1 (Control group) (n=28): AF patients undergoing cardioversion who will receive the standard of care 2. Group 2 (Probiotic group) (n = 28): AF patients undergoing cardioversion who will receive the standard of care in addition to probiotics DAILY orally administered (Probiotics 25 billion) after cardioversion for 12 weeks.
Groups (1 \& 2) will be subjected to cardioversion on admission according to standard protocols and criteria.
Interventions
- Drug Anticoagulant Therapy
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. - Drug Probiotics capsules
Probiotics at a of dose 25 billion / 1 capsule will be orally administered daily for 12 weeks
Primary outcome measures
- Atrial Fibrillation Recurrence [Time frame: 7 days]
Secondary outcome measures (1)
- Atrial Fibrillation Recurrence [Time frame: 12 weeks]
Eligibility criteria
Inclusion criteria
- Female or male aged 40 years or above with BMI less than 40
- Persistent AF patients directly after cardioversion
Exclusion criteria
- History of probiotic supplementation in the previous 6 weeks
- Autoimmune diseases
- Ongoing treatment with immunosuppressive therapies
- Active Infection
- Pregnant or breast-feeding patients
- Active participation in another clinical study
- History of or known allergy or intolerability to the study medications
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Ain Shams University's Hospital — Cairo
Publications
- 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. PMID 40575430
- 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. PMID 39930552
- 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. PMID 36009566
Identifiers
NCT: NCT07568964 · Probiotics in AF patients