Atrial Fibrillation (AF)NCT07568964
Evaluation of Probiotics' Effect on Atrial Fibrillation Recurrence in Patients Undergoing Cardioversion
A study testing Anticoagulant Therapy and Probiotics capsules in people with Atrial Fibrillation (AF), run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this clinical study is to evaluate the efficacy and tolerability of probiotics on atrial fibrillation recurrence. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- Anticoagulant Therapy and Probiotics capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteEgypt
- Study dates
- 10 May 2026to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male aged 40 years or above with BMI less than 40
- Persistent AF patients directly after cardioversion
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Ain Shams University's Hospital
Cairo
Ayman Saleh Professor, +201222124031, maymanmsaleh@yahoo.com
About this study
Official title: 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.
Read the 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:
- 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.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- Anticoagulant Therapy, Probiotics capsules
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anticoagulant TherapyDrug
Also called Rate Control Therapy, Rhythm Control 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.
Probiotics capsulesDrug
Probiotics at a of dose 25 billion / 1 capsule will be orally administered daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Control group | Experimental | 28 AF patients undergoing cardioversion who will receive standard of care Receives: 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 Receives: Drug: Anticoagulant Therapy; Drug: Probiotics capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial Fibrillation Recurrence
Measured: 7 days
Secondary outcomes (1)
Atrial Fibrillation Recurrence
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start10 May 2026 (estimated)
- Primary completion10 May 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Mostafa Mostafa Abdelfatah Raesah, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07568964
- Sponsor's protocol ID
- Probiotics in AF patients
- Status last verified
- May 2026
- First submitted
- 10 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 40575430Chen 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.
PubMed 39930552Drapkina 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.
PubMed 36009566
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotics on Atrial Fibrillation Outcome in Patients Undergoing Cardioversion
- ClinicalTrials.gov ID
- NCT07568964
- Acronym / sponsor ID
- Probiotics in AF patients
- Conditions
- Atrial Fibrillation (AF)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 10 May 2026 (estimated)
- Primary completion
- 10 May 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Control group | Experimental | Drug: Anticoagulant Therapy28 AF patients undergoing cardioversion who will receive standard of care |
| Experimental: Probiotic group | Experimental | Drug: Anticoagulant Therapy, Drug: Probiotics capsules28 AF patients undergoing cardioversion who will receive the standard of care in addition to Probiotics 25 billion daily orally, after cardioversion for 12 weeks |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Female or male aged 40 years or above with BMI less than 40
- Persistent AF patients directly after cardioversion
Key exclusion criteria (7 listed)
- History of probiotic supplementation in the previous 6 weeks
- Autoimmune diseases
- Ongoing treatment with immunosuppressive therapies
- Active Infection
- Pregnant or breast-feeding patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anticoagulant TherapyAlso: Rate Control Therapy, Rhythm Control TherapyDrug: 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 | Experimental: Control group, Experimental: Probiotic group |
| Probiotics capsulesProbiotics at a of dose 25 billion / 1 capsule will be orally administered daily for 12 weeks | Drug | Experimental: Probiotic group |
Primary outcome
Atrial Fibrillation Recurrence
Time frame: 7 days
1 secondary outcome
Atrial Fibrillation Recurrence
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Background: PubMed 40575430Brar 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.
- Background: PubMed 39930552Chen 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.
- Background: PubMed 36009566Drapkina 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.
- Individual participant dataSharing planned: No
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ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anticoagulant Therapy and Probiotics capsules in people with Atrial Fibrillation (AF), run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah M. Raesah (+201018585869, sara.mostafa18@pharma.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial Fibrillation Recurrence (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07568964, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.