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Effect of probiotic supplementation on diabetic nephropathy

The effect of soy milk containing lactobacillus plantarum A7 on inflammatory indices, lipid profile and physical activity in type 2 diabetic patients with nephropathy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201601027479N2
Enrollment
40
Registered
2016-01-25
Start date
2016-01-21
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

Diabetic nephropathy. Glomerular disorders in diabetes mellitus

Interventions

Intervention 1: Soy milk containing lactobacillus plantarum A7, 200 cc orally, once a day for 2 months. Intervention 2: Soy milk without lactobacillus plantarum A7 , 200 cc orally, once a day for 2 mo
Treatment - Other
Soy milk containing lactobacillus plantarum A7, 200 cc orally, once a day for 2 months
Soy milk without lactobacillus plantarum A7 , 200 cc orally, once a day for 2 months

Sponsors

Isfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion criteria: Having T2DM ;having micro or macro albuminuria ;GFR higher than 60 ml/min ;not having hepatic gastrointestinal and thyroid diseases ;not having rheumatoid arthritis ;not having any kind of allergy or acute infection ;not consuming vitamin mineral or omega-3 supplements 3 weeks before beginning of the trial and during the trial ;not consuming antibiotics 1 month before the trial and during the trial ;absence of pregnancy or lactating ;not smoking ;not having any specific diet. Exclusion criteria: Not adhering to the administrated diet ;occurrence of other kidney diseases ;cardiac ischemia ;gastrointestinal ;hepatic or thyroid diseases ;acute infection ;needing to be dialysed ;undergoing kidney transplantation ;any kind of surgery or occurrence of pregnancy ;starting to consume drugs that may affect protein excretion such as NSAIDs or ACE-I.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Serum creatinine. Timepoint: Before the intervention and 2 months after beginning of the intervention. Method of measurement: mg/dl , biochemical analysis.;Proteinuria. Timepoint: Before the intervention and 2 months after beginning of the intervention. Method of measurement: mg/day, Biochemical analysis.;IL-18. Timepoint: Before the intervention and 2 months after beginning of the intervention. Method of measurement: ?g/ml , ELISA.;Serum sialic acid. Timepoint: Before the intervention and 2 months after beginning of the intervention. Method of measurement: mmol/l , ELISA.;TNF-a. Timepoint: Before the intervention and 2 months after beginning of the intervention. Method of measurement: ?g/ml , ELISA.;HsCRP. Timepoint: Before the intervention and 2 months after beginning of the intervention. Method of measurement: mg/dl , ELISA.;GFR. Timepoint: Before the intervention and 2 months after beginning of the intervention. Method of measurement: ml/min , calculation.;Serum cholestrol. Timepoint: Before the intervention and 2 months after beginning of the intervention. Method of measurement: mg/dl , biochemical analysis.;Serum triglyceride. Timepoint: Before the intervention and 2 months after beginning of the intervention. Method of measurement: mg/dl , biochemical analysis.;Serum LDL-C. Timepoint: Before the intervention and 2 months after beginning of the intervention. Method of measurement: mg/dl , biochemical analysis.;Serum HDL-C. Timepoint: Before the intervention and 2 months after beginning of the intervention. Method of measurement: mg/dl , biochemical analysis.;Physical activity. Timepoint: Before the intervention and 2 months after beginning of the intervention. Method of measurement: Met-h/wk , Questionnaire.

Secondary

MeasureTime frame
Serum sodium. Timepoint: Before the intervention and 2 months after beginning of the intervention. Method of measurement: mg/dl ,flame photometry.;Serum potassium. Timepoint: Before the intervention and 2 months after beginning of the intervention. Method of measurement: mg/dl ,flame photometry.;Fasting blood sugar. Timepoint: Before the intervention and 2 months after beginning of the intervention. Method of measurement: mg/dl , Biochemical analysis.;Serum genistein. Timepoint: Before the intervention and 2 months after beginning of the intervention. Method of measurement: nmol/l , TR-FIA.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactBehnood Abbasi

Isfahan University of Medical Sciences

b.abbasi@nnftri.ac.ir+98 31 3792 9776

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 25, 2026