Effect of supplementation in treatment of patients with diabetic hemodialysis

Clinical trial of the effect of probiotic supplementation compared with the placebo on metabolic profiles in patients with diabetic hemodialysis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201603185623N69

Enrollment

Registered

2016-03-23

Start date

2016-02-29

Completion date

Unknown

Last updated

2019-11-05

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

Conditions

?????????. Chronic kidney disease

Interventions

Intervention 1: Intervention group: Probiotic supplements containing three strains of Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus casei (2×109 CFU/g) and Bifidobacterium bifidum (2×109 CFU

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Patients with diabetic hemodialysis aged 18 to 80 years.

Exclusion criteria

Exclusion criteria: Pregnant women Intestinal diseases Taking probiotic supplements and other forms of probiotics including probiotic yogurt, kefir and other fermented foods Taking prebiotic, antioxidant and/or anti-inflammatory supplements such as vitamin E, vitamin C and omega-3 fatty acids Taking antibiotics, immunosuppressive medications within 3 months prior to the enrollment in the study

Design outcomes

Primary

Measure	Time frame
Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Insulin resistance. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Calcution using HOMA formula.	—

Secondary

Measure	Time frame
Triglycerides. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Enzymatic kit.;Total cholesterol. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Enzymatic kit.;HDL. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Enzymatic kit.;Total antioxidant. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Spectrophotometry.;Malondialdehyde. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Spectrophotometry.;Nitric oxide. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Spectrophotometry.;Hs-CRP. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Elisa kit.;Creatinine. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Enzymatic kit.;BUN. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Enzymatic kit.;Albumin. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Enzymatic kit.;TIBC. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Enzymatic kit.;LDL. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Enzymatic kit.;VLDL. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Enzymatic kit.;Sodium. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Flame photometry.;Potassium. Timepoint: At the beginning of the study and 12 weeks after the intervent	—

Measure

Time frame

Triglycerides. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Enzymatic kit.;Total cholesterol. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Enzymatic kit.;HDL. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Enzymatic kit.;Total antioxidant. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Spectrophotometry.;Malondialdehyde. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Spectrophotometry.;Nitric oxide. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Spectrophotometry.;Hs-CRP. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Elisa kit.;Creatinine. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Enzymatic kit.;BUN. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Enzymatic kit.;Albumin. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Enzymatic kit.;TIBC. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Enzymatic kit.;LDL. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Enzymatic kit.;VLDL. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Enzymatic kit.;Sodium. Timepoint: At the beginning of the study and 12 weeks after the intervention. Method of measurement: Flame photometry.;Potassium. Timepoint: At the beginning of the study and 12 weeks after the intervent

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZatollah Asemi

Kashan University of Medical Sciences

asemi_r@yahoo.com+98 31 5546 3378

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026