NCT07568964

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
16mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2026

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 6, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

May 10, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2027

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

1 year

First QC Date

April 10, 2026

Last Update Submit

May 1, 2026

Conditions

Atrial Fibrillation (AF)

Outcome Measures

Primary Outcomes (1)

  • Atrial Fibrillation Recurrence

    7 days

Secondary Outcomes (1)

  • Atrial Fibrillation Recurrence

    12 weeks

Study Arms (2)

Experimental: Control group

EXPERIMENTAL

28 AF patients undergoing cardioversion who will receive standard of care

Drug: Anticoagulant Therapy

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

Drug: Anticoagulant TherapyDrug: Probiotics capsules

Interventions

Anticoagulant TherapyDRUG

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.

Also known as: Rate Control Therapy, Rhythm Control Therapy
Experimental: Control groupExperimental: Probiotic group
Probiotics capsulesDRUG

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

Experimental: Probiotic group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University's Hospital

Cairo, Egypt

Location

Related Publications (3)

  • 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

    BACKGROUND

  • 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

    BACKGROUND

  • 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

    BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Central Study Contacts

Sarah M. Raesah

CONTACT

+201018585869sara.mostafa18@pharma.asu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching Assistant and Researcher in Clinical Pharmacy Department, Faculty of Pharmacy, Ain Shams University.

Study Record Dates

First Submitted

April 10, 2026

First Posted

May 6, 2026

Study Start (Estimated)

May 10, 2026

Primary Completion (Estimated)

May 10, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

May 6, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)