Relationship Between Gut Microbiota And Anemia In Patients With Chronic Renal Failure

NCT03220685 | Completed DMC

• 1 other identifier: Amr abdelrady 123
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 . 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.

Conditions

Gut Micrbota and Its Relation to Anemia of CKD Patients

Keywords

Microbiota

Outcome Measures

Primary Outcomes (1)

• Relationship Between Gut Microbiota And Anemia In Chronic Kidney Disease (CKD) patients

  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.

  2 years

Study Arms (2)

1.normal persons

normal persons include 25 person

Biological: Stool analysis

2.CKD pt with anemia

includes 25 previously diagnosed CKD patients with or without treatment of anemia.

Interventions

Stool analysis BIOLOGICAL

Bacterial extraction in faeces by repeated fractional centrifugation to obtain bacterial mass and DNA sequencing.

1.normal persons

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Subjects participating in this study are CKD patients having eGFR less than 60 mL/min/1.73m2 for more than three months.
• \. Individuals may be taking laxative drugs but they must be discontinued 3or more weeks before admission.
• \. Age 18-70 years (in order to minimize the effect of aging on gut microbiota).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut universitu

Asyut, Egypt

Location

MeSH Terms

Interventions

Occult Blood

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Samir Kamal, Dr

  Lecturer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 14, 2017
• First Posted: July 18, 2017
• Study Start: June 25, 2019
• Primary Completion: January 1, 2022
• Study Completion: March 1, 2022
• Last Updated: July 3, 2025

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)