Evaluation of Probiotics' Effect on Atrial Fibrillation Recurrence in Patients Undergoing Cardioversion

May 1, 2026 updated by: Sarah Mostafa Mostafa Abdelfatah Raesah, Ain Shams University

Effect of Probiotics on Atrial Fibrillation Outcome in Patients Undergoing Cardioversion

The aim of this clinical study is to evaluate the efficacy and tolerability of probiotics on atrial fibrillation recurrence.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ain Shams University's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Female or male aged 40 years or above with BMI less than 40
  2. Persistent AF patients directly after cardioversion

Exclusion Criteria:

  1. History of probiotic supplementation in the previous 6 weeks
  2. Autoimmune diseases
  3. Ongoing treatment with immunosuppressive therapies
  4. Active Infection
  5. Pregnant or breast-feeding patients
  6. Active participation in another clinical study
  7. History of or known allergy or intolerability to the study medications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Control group
28 AF patients undergoing cardioversion who will receive standard of care
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.
Other Names:
  • Rate Control Therapy
  • Rhythm Control Therapy
Experimental: Experimental: Probiotic group
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
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.
Other Names:
  • Rate Control Therapy
  • Rhythm Control Therapy
Drug: Probiotics capsules
Probiotics at a of dose 25 billion / 1 capsule will be orally administered daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Atrial Fibrillation Recurrence
Time Frame: 7 days
7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Atrial Fibrillation Recurrence
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Brar, A. S., Vemula, S. L., Yanamaladoddi, V., Sodhi, S., Hatwal, J., Sohal, A., & Batta, A. (2025). Impact of gut microbiome on atrial fibrillation: Mechanistic insights and future directions in individualized medicine. In World Journal of Cardiology (Vol. 17, Issue 6). Baishideng Publishing Group Inc. https://doi.org/10.4330/wjc.v17.i6.107386
  • Chen, J., Wang, Y., Wang, K., Mei, Z. and Wang, L. (2025), Exploring the Axis of Gut Microbiota-Inflammatory Cytokine-Atrial Fibrillation in the Pathogenesis of Atrial Fibrillation. J Cell Mol Med, 29: e70379. https://doi.org/10.1111/jcmm.70379
  • Drapkina, O. M., Yafarova, A. A., Kaburova, A. N., & Kiselev, A. R. (2022). Targeting Gut Microbiota as a Novel Strategy for Prevention and Treatment of Hypertension, Atrial Fibrillation and Heart Failure: Current Knowledge and Future Perspectives. In Biomedicines (Vol. 10, Issue 8). MDPI. https://doi.org/10.3390/biomedicines10082019

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 10, 2026

Primary Completion (Estimated)

May 10, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

April 10, 2026

First Submitted That Met QC Criteria

May 1, 2026

First Posted (Actual)

May 6, 2026

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Probiotics in AF patients

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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