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The effect of Synbiotics and Probiotics supplementation in reducing cardiovascular complications in hemodialysis patients

The effect of Synbiotics and Probiotics supplementation on renal function, systemic and vascular inflammations, heat shock protein 70 Antibody (HSP70) and cytokeratin-18 (k-18) in hemodialysis patients

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2017041233393N1
Enrollment
75
Registered
2017-04-23
Start date
2017-04-04
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

hemoldialysis. Extracorporeal dialysis

Interventions

Prevention
Placebo
Intervention 1: Probiotics supplementation with one 5 gr Probiotics saches (105 bifidobacter and lactobacilus) and two 5 gr sache of maltodextrin. Intervention 2: Synbiotics supplementation with two 5
Probiotics supplementation with one 5 gr Probiotics saches (105 bifidobacter and lactobacilus) and two 5 gr sache of maltodextrin
Synbiotics supplementation with two 5 gr sache of prebiotics (FOS, GOS, Inulin) and one 5 gr sache of probiotics (105 lactobasilus, bifidobacter)
Placebo cantaining three 5 gr saches of maltodextrin

Sponsors

Vice chancellor for research, Ahvaz Jundishapour University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria were: willingness to cooperate; at least 3 months renal failure on hemodialysis, 4 hours hemodialysis three times a week; aged between 65-30 years Exclusion criteria: history of kidney transplantation; infection; history of hospitalization in the last month; useing any products or supplements containing probiotics and prebiotics and antibiotics in 1 months; using vitamins fiber omega-3 antioxidants within 3 weeks before or during the study; using nonsteroidal anti-inflammatory drug NSAIDs; progesterone, immunosuppressive drugs; diuretics and corticosteroids; the radiation in the area of small and large bowel; with Being irritable bowel syndrome; Crohn's disease or ulcerative colitis; a severe malnutrition (SGA: C); swelling and bloating

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
?Antibody HSP70. Timepoint: at first and two months after intervention. Method of measurement: ELISA.;Interleukin -6. Timepoint: at first and two months after intervention. Method of measurement: ELISA.;ICAM-1. Timepoint: at first and two months after intervention. Method of measurement: ELISA.;VCAM-1. Timepoint: at first and two months after intervention. Method of measurement: ELISA.;Cytokeratin-18. Timepoint: at first and two months after intervention. Method of measurement: ELISA.;Endotoxin. Timepoint: at first and two months after intervention. Method of measurement: ELISA.;BUN. Timepoint: at first and two months after intervention. Method of measurement: Enzymatic.;Keratinin. Timepoint: at first and two months after intervention. Method of measurement: Enzymatic.;Hs-CRP. Timepoint: at first and two months after intervention. Method of measurement: ELISA.;The number of Lactobacillus colonies. Timepoint: at first and two months after intervention. Method of measurement: dilution.;The number of bifidobacter colonies. Timepoint: at first and two months after intervention. Method of measurement: dilution.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNeda Haghighat

Ahvaz Jundishapour University of Medical Sciences

haghighat.n@ajums.ac.ir+98 61 3373 8330

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Mar 1, 2026