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NCT Number: NCT07568964

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

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

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Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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:

  • Group 1 (Control group) (n=28): AF patients undergoing cardioversion who will receive the standard of care
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Rate Control Therapy, Rhythm Control Therapy

Probiotics capsules

Drug

Probiotics at a of dose 25 billion / 1 capsule will be orally administered daily for 12 weeks

Primary outcomes

  1. Atrial Fibrillation Recurrence

    Time frame: 7 days

Secondary outcomes

  1. Atrial Fibrillation Recurrence

    Time frame: 12 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah M. Raesah

CONTACT

[email protected]

+201018585869

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Effect of Probiotics on Atrial Fibrillation Outcome in Patients Undergoing Cardioversion

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 6, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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