Gut Micrbota and Its Relation to Anemia of CKD PatientsNCT03220685
Relationship Between Gut Microbiota And Anemia In Patients With Chronic Renal Failure
An observational study of Gut Micrbota and Its Relation to Anemia of CKD Patients, run by Assiut University at 1 site in Egypt.
Trial summary
The human intestinal tract harbours a diverse and complex microbial community which plays a central role in human health. It has been estimated that our gut contains in the range of 1000 bacterial species and 100-fold more genes than are found in the human genome . Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gut Micrbota and Its Relation to Anemia of CKD Patients
- What is being tested?
- Stool analysis
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jun 2019to 1 Mar 2022
- Phase
- Observational
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: To all patients history and clinical examination will be done plus routine investigation will be also done. Laboratory and imaging evaluation, as following:- 1. Complete blood count 2. serum creatinin and eGFR. 3. Bacterial extraction in faeces by repeated fractional centrifugation to obtain bacterial mass and DNA sequencing. 4. H.Pylori Ag in stool. 5. Iron studies (TSAT). 6. Abdominal ultrasound.
Who may be able to join
- 1 - Subjects participating in this study are CKD patients having eGFR less than 60 mL/min/1.73m2 for more than three months.
- 2. Individuals may be taking laxative drugs but they must be discontinued 3or more weeks before admission.
- 3. Age 18-70 years (in order to minimize the effect of aging on gut microbiota).
Who cannot join
- Subjects with a history or clinical manifestation of:
- Gastrointestinal disease, including inflammatory bowel diseases (e.g. Crohn s disease and ulcerative colitis), malabsorption syndromes (e.g. celiac disease), gastric ulcer (active) and irritable bowel syndrome.
- Lactose intolerance.
- Eating disorders such as anorexia nervosa , bulimia and binge eating syndrome.
- Taking weight loss drugs.
- Use of any antibiotic or probiotic agents within 6 months prior to minimize the potential effects of these substances on the gut microbiota.
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- Use of antacids (Proton pump inhibitors, H2 antagonists or aluminum/magnesium hydroxide) 3 months prior to the study assessed by self-report because a modified gastric pH might affect the gut microbiota as well.
- Evidence of alcohol and/or drug abuse (more than 3 drinks per day and use of drugs, such as amphetamines, cocaine, heroin, or marijuana).
- Diabetic patients.
- Patients on dialysis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between Gut Microbiota And Anemia In Patients With Chronic Renal Faliure
The human intestinal tract harbours a diverse and complex microbial community which plays a central role in human health. It has been estimated that our gut contains in the range of 1000 bacterial species and 100-fold more genes than are found in the human genome . This community is commonly referred to as our hidden metabolic 'organ' due to their immense impact on human wellbeing, including host metabolism, physiology, nutrition and immune function. It is now apparent that our gut microbiome coevolves with us and that changes to this population can have major consequences, both beneficial and harmful, for human health. Indeed, it has been suggested that disruption of the gut microbiota (or dysbiosis) can be significant with respect to pathological intestinal conditions such as obesity and malnutritio, systematic diseases such as diabetes and chronic inflammatory diseases such as inflammatory bowel disease (IBD), encompassing ulcerative colitis (UC) and Crohn's disease (CD) .
The role of the gut microbiome in human health and disease is becoming clearer thanks to high throughput sequencing technologies (HTS) as well as parallel recent developments in non genomic techniques.
Read the detailed description
From the early stages of chronic kidney disease (CKD) there is a quantitative and qualitative alteration of intestinal microflora (dysbiosis); so the composition and metabolic activities of microflora are changed in CKD. These alterations include changes in intestinal transit, decreased protein absorption, decrease in dietary fibre intake, treatment with oral iron and frequent use of antibiotics.
All of this contributes to systemic inflammation and the accumulation of uraemic toxins that are absorbed by intestine and eliminated by the kidney.
This uraemic toxins have been associated with deleterious biological effects in different tissues and cell lines and with an increased risk of the progression of CKD, morbidity and mortality)
- Progression of CKD: both indoxyl sulfate(IS) and p-cresyl sulfate (PCS) are associated to the development of fibrosis, deterioration of renal function and disease progression . In vitro studies have shown a deleterious effect of these molecules on renal tubular cells. - Cardiovascular complications: in CKD patients, IS is associated with endothelial damage, arterial stiffness and aortic calcification .
- Anaemia: IS has been associated with anaemia of the renal patient; it interfere with the adequate production of erythropoietin and increased eryptosis (programmed cell death of red blood cells) .Polyamines are associated to anaemia in renal patients, through an intra-erythrocytic effect ,reduces erythropoiesis, and inhibit the activity of erythropoietin)
- Alterations of bone-mineral metabolism: IS reduces bone formation by promoting oxidative stress in osteoblasts and inducing resistance to PTH, which favours the development a dynamic bone .There is a positive correlation between FGF-23 and IS serum levels, suggesting an association between this molecule and metabolic bone disease in uraemic patients .
- Insulin resistance: In CKD patients the catabolism of insulin is reduced and often, they also have insulin resistance, which is associated with an increased risk of mortality; it seems that insulin resistance is related to some of the uremic toxins .
- Being tested
- Stool analysis
- Keywords
- Microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool analysisBiological
Bacterial extraction in faeces by repeated fractional centrifugation to obtain bacterial mass and DNA sequencing.
| Study group | Role | What they receive |
|---|---|---|
| 1.normal persons | normal persons include 25 person Receives: Biological: Stool analysis | |
| 2.CKD pt with anemia | includes 25 previously diagnosed CKD patients with or without treatment of anemia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship Between Gut Microbiota And Anemia In Chronic Kidney Disease (CKD) patients
- Identifying dysbiosis and its role in anemia of CKD patients.
- Targeting of specific components of the gut microbiome of CKD patients and their correlation with anemia.
- To identify the effect of treatment of anemia with erythropoietin and iron therapy in CKD patients on the gut microbiota.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start25 Jun 2019
- Primary completion1 Jan 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut Micrbota and Its Relation to Anemia of CKD PatientsStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Ismaiel, Assiut University
- Investigators
- Samir Kamal, Dr, Principal investigator, Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03220685
- Sponsor's protocol ID
- Amr abdelrady 123
- Status last verified
- Oct 2021
- First submitted
- 14 Jul 2017
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Gut Microbiota And Anemia In Patients With Chronic Renal Faliure
- ClinicalTrials.gov ID
- NCT03220685
- Acronym / sponsor ID
- Amr abdelrady 123
- Keywords
- Microbiota
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 25 Jun 2019 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 18 Jul 2017 (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 human intestinal tract harbours a diverse and complex microbial community which plays a central role in human health. It has been estimated that our gut contains in the range of 1000 bacterial species and 100-fold more genes than are found in the human genome . This community is commonly referred to as our hidden metabolic 'organ' due to their immense impact on human wellbeing, including host metabolism, physiology, nutrition and immune function. It is now apparent that our gut microbiome coevolves with us and that changes to this population can have major consequences, both beneficial and harmful, for human health. Indeed, it has been suggested that disruption of the gut microbiota (or dysbiosis) can be significant with respect to pathological intestinal conditions such as obesity and malnutritio, systematic diseases such as diabetes and chronic inflammatory diseases such as inflammatory bowel disease (IBD), encompassing ulcerative colitis (UC) and Crohn's disease (CD) .
The role of the gut microbiome in human health and disease is becoming clearer thanks to high throughput sequencing technologies (HTS) as well as parallel recent developments in non genomic techniques.
Detailed description
From the early stages of chronic kidney disease (CKD) there is a quantitative and qualitative alteration of intestinal microflora (dysbiosis); so the composition and metabolic activities of microflora are changed in CKD. These alterations include changes in intestinal transit, decreased protein absorption, decrease in dietary fibre intake, treatment with oral iron and frequent use of antibiotics.
All of this contributes to systemic inflammation and the accumulation of uraemic toxins that are absorbed by intestine and eliminated by the kidney.
This uraemic toxins have been associated with deleterious biological effects in different tissues and cell lines and with an increased risk of the progression of CKD, morbidity and mortality)
- Progression of CKD: both indoxyl sulfate(IS) and p-cresyl sulfate (PCS) are associated to the development of fibrosis, deterioration of renal function and disease progression . In vitro studies have shown a deleterious effect of these molecules on renal tubular cells. - Cardiovascular complications: in CKD patients, IS is associated with endothelial damage, arterial stiffness and aortic calcification .
- Anaemia: IS has been associated with anaemia of the renal patient; it interfere with the adequate production of erythropoietin and increased eryptosis (programmed cell death of red blood cells) .Polyamines are associated to anaemia in renal patients, through an intra-erythrocytic effect ,reduces erythropoiesis, and inhibit the activity of erythropoietin)
- Alterations of bone-mineral metabolism: IS reduces bone formation by promoting oxidative stress in osteoblasts and inducing resistance to PTH, which favours the development a dynamic bone .There is a positive correlation between FGF-23 and IS serum levels, suggesting an association between this molecule and metabolic bone disease in uraemic patients .
- Insulin resistance: In CKD patients the catabolism of insulin is reduced and often, they also have insulin resistance, which is associated with an increased risk of mortality; it seems that insulin resistance is related to some of the uremic toxins .
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1.normal persons | – | Biological: Stool analysisnormal persons include 25 person |
| 2.CKD pt with anemia | – | –includes 25 previously diagnosed CKD patients with or without treatment of anemia. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- To all patients history and clinical examination will be done plus routine investigation will be also done. Laboratory and imaging evaluation, as following:- 1. Complete blood count 2. serum creatinin and eGFR. 3. Bacterial extraction in faeces by repeated fractional centrifugation to obtain bacterial mass and DNA sequencing. 4. H.Pylori Ag in stool. 5. Iron studies (TSAT). 6. Abdominal ultrasound.
Key inclusion criteria (3 listed)
- 1 - Subjects participating in this study are CKD patients having eGFR less than 60 mL/min/1.73m2 for more than three months.
- 2. Individuals may be taking laxative drugs but they must be discontinued 3or more weeks before admission.
- 3. Age 18-70 years (in order to minimize the effect of aging on gut microbiota).
Key exclusion criteria (10 listed)
- Subjects with a history or clinical manifestation of:
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 |
|---|---|---|
| Stool analysisBacterial extraction in faeces by repeated fractional centrifugation to obtain bacterial mass and DNA sequencing. | Biological | 1.normal persons |
Primary outcome
Relationship Between Gut Microbiota And Anemia In Chronic Kidney Disease (CKD) patients
Time frame: 2 years
1. Identifying dysbiosis and its role in anemia of CKD patients. 2. Targeting of specific components of the gut microbiome of CKD patients and their correlation with anemia. 3. To identify the effect of treatment of anemia with erythropoietin and iron therapy in CKD patients on the gut microbiota.
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 3 Jul 2025.
- Individual participant dataSharing planned: No
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.
Samir Kamal, Dr principal investigator
Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gut Micrbota and Its Relation to Anemia of CKD Patients, run by Assiut 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 10 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 3 Jul 2025. 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?
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?
Relationship Between Gut Microbiota And Anemia In Chronic Kidney Disease (CKD) patients (time frame: 2 years). 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 3 Jul 2025.