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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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20131013014994N7
Enrollment
34
Registered
2022-04-27
Start date
2022-05-22
Completion date
Unknown
Last updated
2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hemodialysis patients. Cloudy (hemodialysis) (peritoneal) dialysis effluent

Interventions

Intervention 1: During a 12-week intervention in hemodialysis patients, the intervention group received two synbiotic capsules daily, after lunch and dinner. Each synbiotic capsule (under the brand na
Bio Fermentation Company, Tehran, Iran) contains Lactobacillus rhamnosus, Lactobacillus casei, lactobacillus acidophilus, Lactobacillus bulgaricus, Lactobacillus fermentum, Lactobacillus plantarus and

Sponsors

Kermanshah University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHadi Abdollahzad

Kermanshah University of Medical Sciences

abdollahzad@kums.ac.ir+98 83 3710 2008

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 6, 2026