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Effect of synbiotics supplement on fatigue and sleep quality in hemodialysis patients with chronic kidney disease

Phase 3
Conditions
chronic kidney disease.
Chronic kidney disease, stage 4 (severe)
N18.4
Registration Number
IRCT20210117050055N1
Lead Sponsor
Sabzevar University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
60
Inclusion Criteria

A patient with a diagnosis of chronic kidney disease who undergoing hemodialysis for at least 3 months.
signing informed consent for participation in the study
Patient with arteriovenous fistula or permanent catheter or venous arterial graft
The patient undergoing hemodialysis 3 times a week for 4 hours each time
Patient with KT / V> 1
Do not suffer from hearing and vision disorders
No neurological disorders and a history of hospitalization in the psychiatric ward
age range of 18 to 65 years

Exclusion Criteria

Active infection during the last 30 days
Pregnant or lactating mothers
Taking antibiotics, prebiotics, probiotics, synbiotics, vitamin supplements or antioxidants during the last 30 days
Suffering from autoimmune diseases or connective tissue disorders
History of cardiovascular diseases
Diabetic foot infection
Gastrointestinal diseases (inflammatory bowel disease, ulcerative colitis, Crohn's disease, celiac disease, lactose intolerance or allergy, irritable bowel syndrome)
Liver disease (such as hepatitis B, hepatitis C)
suffering from various types of malignancies
Smoking more than 10 cigarettes per day
Participate in other drug interventions
hemoglobin less than 8 mg/dl
PSQI score less than 6 (good sleep quality)
acquisition of CFS score less than 18

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Fatigue. Timepoint: 2 months. Method of measurement: Chalders Fatigue Scale.;Sleep quality. Timepoint: 2 months. Method of measurement: Pittsburgh Sleep Quality Scale.
Secondary Outcome Measures
NameTimeMethod
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