The effect of synbiotic supplementation on plasma levels of Advanced Glycation End Products and cardiovascular risk factors in hemodialysis patients: a double-blind clinical trial

Phase 3

Conditions: hemodialysis patients.
Cloudy (hemodialysis) (peritoneal) dialysis effluent
R88.0

Registration Number: IRCT20131013014994N7

Lead Sponsor: Kermanshah University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 34

Inclusion Criteria

Perform HD treatment at least twice a week for a maximum of 4 hours each time
Treatment under HD for at least 6 months
No pregnancy or breastfeeding
No immune system defects
No history of active cancers
No history of severe chronic diseases and acute medical conditions such as lung disease, cardiovascular disease, liver disease and acute pancreatitis
No addiction to alcohol or drugs
Lack of severe digestive disorders and diseases, HIV disease, mental problems
Ability to drink at least 200 ml of water per day
Life expectancy and survival for at least 3 months
Confirmation of written consent

Exclusion Criteria

Patients with severe edema
People who had infection 4 weeks ago
People who took synbiotics, probiotics, prebiotics, or antibiotics during the 4 weeks before the study
Candidates for kidney and organ transplantation or peritoneal dialysis during 3 months of study
Taking immunosuppressive drugs or anticoagulants and chemotherapy drugs
Sensitivity to complementary compounds
The patient's unwillingness to participate in the study
Lack of complete answers to questions
Report side effects from taking synbiotics

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plasma levels of advanced glycation end products in hemodialysis patients. Timepoint: First study (before the intervention) and end of the study (end of week 12). Method of measurement: Blood sample- Advanced Glycation End Products (AGE) ELISA Kit.

Secondary Outcome Measures

Name	Time	Method
Plasma homocysteine levels in hemodialysis patients. Timepoint: Beginning of the study (before the intervention) and end of the study (end of week 12). Method of measurement: Blood sample - High performance liquid chromatography.;Plasma fibrinogen levels in hemodialysis patients. Timepoint: Beginning of the study (before the intervention) and end of the study (end of week 12). Method of measurement: Blood sample - coagulation factor.;Gastrointestinal function. Timepoint: Beginning of the study (before the intervention) and end of the study (end of week 12). Method of measurement: THE GASTROINTESTINAL SYMPTOM RATING SCALE (GSRS).;Fasting blood sugar and HgA1C. Timepoint: Beginning of the study (before the intervention) and end of the study (end of week 12). Method of measurement: Blood sample.