AnaemiaPhase 3NCT07296146
Probiotics Against Erythropoietin Resistance in Chronic Kidney Disease Patients.
A Phase 3 study testing Erythropoietin + Probiotic and EPO in people with Anaemia and Chronic Kidney Disease, run by Badr University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to assess whether probiotic supplementation can improve the hematological response of CKD patients to erythropoietin therapy and prevent or reduce erythropoietin resistance. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anaemia, Chronic Kidney Disease, Regular Hemodialysis
- What is being tested?
- Erythropoietin + Probiotic and EPO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2026to 15 Aug 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with end stage renal disease for more than 3 months on regular hemodialysis (GFR less than 15 ml/min/m2
- Receiving stable doses of erythropoietin therapy
- Able and willing to provide informed consent
Who cannot join
- Recent probiotic, antibiotic, or immunosuppressive therapy
- Microcytic hypochromic anemia.
- Patients with hyperparathyroidism
- Recent or planned kidney transplantation Gastrointestinal disorders (active IBD, cancer)
- Pregnancy or lactation
- Severe comorbidities (e.g., active infection, malignancies)
- Cognitive or physical inability to comply with protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Probiotic Supplementation on Resistant Anaemia to Erythropoietin in Chronic Kidney Disease Patients.
The goal of this clinical trial is to assess whether probiotic supplementation can improve the hematological response of CKD patients to erythropoietin therapy and prevent or reduce erythropoietin resistance. The main questions it aims to answer are:
Can probiotic be used as an adjuvant strategy in anemia management and increasing ESA responsiveness in CKD? What medical problems do participants have when taking probiotic? Researchers will compare Erythropoietin only with Erythropoietin + Probiotic to see if Probiotic aids in treating anaemic chronic kidney disease patients.
Read more
Participants will:
Take Erythropoietin + Probiotic or Probiotic only every day for 3 months Visit the clinic once every 4 weeks for checkups and tests Keep a diary of their symptoms
- Conditions
- Anaemia, Chronic Kidney Disease, Regular Hemodialysis
- Being tested
- Erythropoietin + Probiotic, EPO
- Keywords
- Probiotic, erythropoietin, resistant anaemia, chronic kidney disease patients
- Medical subject headings
- Anemia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erythropoietin + ProbioticDrug
Anaemic chronic kidney disease patients on regular hemodialysis treated with Erythropoietin + Probiotic
EPODrug
Anaemic chronic kidney disease patients on regular hemodialysis treated with Erythropoietin
| Study group | Role | What they receive |
|---|---|---|
| EPO + Probiotic | Active comparator | EPO (4000 IU) + Probiotic Receives: Drug: Erythropoietin + Probiotic |
| EPO | Active comparator | Erythropoietin (Epoetin 4000 IU) Receives: Drug: EPO |
What is being measured
The primary outcome is the main question the study is designed to answer.
- Hemoglobin concentration
- Hemoglobin concentration (g/dL)at 2 weeks, and 3-months postintervention
Measured: at baseline, and 3-months postintervention
- Erythropoietin resistance index (ERI)
- ERI = (ESA dose per week) / (body weight) / (hemoglobin level).
Measured: at baseline, and 3-months postintervention
Secondary outcomes (2)
Serum creatine
mg/dl
Measured: at baseline, and monthly (after 1,2,3 moths)
Urea Reduction Ratio
Measured: at baseline, and monthly (after 1,2,3 moths)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start1 Feb 2026
- Primary completion1 Aug 2026
- Study completion15 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnaemiaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Badr University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Said Sawan, Badr University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07296146
- Sponsor's protocol ID
- 121-2025
- Status last verified
- Oct 2026
- First submitted
- 19 Nov 2025
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotic Supplementation on Resistant Anaemia to Erythropoietin in Chronic Kidney Disease Patients.
- ClinicalTrials.gov ID
- NCT07296146
- Acronym / sponsor ID
- 121-2025
- Conditions
- Anaemia, Chronic Kidney Disease, Regular Hemodialysis
- Keywords
- Probiotic, erythropoietin, resistant anaemia, chronic kidney disease patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Badr UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 15 Aug 2026 (actual)
- First posted
- 22 Dec 2025 (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 goal of this clinical trial is to assess whether probiotic supplementation can improve the hematological response of CKD patients to erythropoietin therapy and prevent or reduce erythropoietin resistance. The main questions it aims to answer are:
Can probiotic be used as an adjuvant strategy in anemia management and increasing ESA responsiveness in CKD? What medical problems do participants have when taking probiotic? Researchers will compare Erythropoietin only with Erythropoietin + Probiotic to see if Probiotic aids in treating anaemic chronic kidney disease patients.
Participants will:
Take Erythropoietin + Probiotic or Probiotic only every day for 3 months Visit the clinic once every 4 weeks for checkups and tests Keep a diary of their symptoms
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EPO + Probiotic | Active comparator | Drug: Erythropoietin + ProbioticEPO (4000 IU) + Probiotic |
| EPO | Active comparator | Drug: EPOErythropoietin (Epoetin 4000 IU) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients with end stage renal disease for more than 3 months on regular hemodialysis (GFR less than 15 ml/min/m2
- Receiving stable doses of erythropoietin therapy
- Able and willing to provide informed consent
Key exclusion criteria (7 listed)
- Recent probiotic, antibiotic, or immunosuppressive therapy
- Microcytic hypochromic anemia.
- Patients with hyperparathyroidism
- Recent or planned kidney transplantation Gastrointestinal disorders (active IBD, cancer)
- Pregnancy or lactation
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 |
|---|---|---|
| Erythropoietin + ProbioticAnaemic chronic kidney disease patients on regular hemodialysis treated with Erythropoietin + Probiotic | Drug | EPO + Probiotic |
| EPOAnaemic chronic kidney disease patients on regular hemodialysis treated with Erythropoietin | Drug | EPO |
Primary outcome
- Hemoglobin concentration
Time frame: at baseline, and 3-months postintervention
- Hemoglobin concentration (g/dL)at 2 weeks, and 3-months postintervention
- Erythropoietin resistance index (ERI)
Time frame: at baseline, and 3-months postintervention
- ERI = (ESA dose per week) / (body weight) / (hemoglobin level).
2 secondary outcomes
Serum creatine
Time frame: at baseline, and monthly (after 1,2,3 moths)
Urea Reduction Ratio
Time frame: at baseline, and monthly (after 1,2,3 moths)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Erythropoietin + Probiotic and EPO in people with Anaemia and Chronic Kidney Disease, run by Badr 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 3 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: finished, as of the sponsor's last update on 30 Oct 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- Hemoglobin concentration (time frame: at baseline, and 3-months postintervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2026.