Effect of probiotics on insulin resistance and oxidative stress markers in diabetic patients with end-stage renal disease on hemodialysis

A RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED TRIAL TO ASSESS SAFETY AND EFFICACY OF PROBIOTICS ON INSULIN RESISTANCE AND OXIDATIVE STRESS MARKERS IN DIABETIC PATIENTS WITH END-STAGE RENAL DISEASE ON HEMODIALYSIS

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/11/038044

Enrollment

Registered

2021-11-15

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-29

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

Conditions

Health Condition 1: E112- Type 2 diabetes mellitus with kidney complications

Interventions

Intervention1: UB0316: Lactobacillus salivarius UBLS-22, Lactobacillus casei UBLC-42, Lactobacillus plantarum UBLP-40, Lactobacillus acidophilus UBLA-34, Bifidobacterium breve UBBr-01, Bacillus coagul

Eligibility

Inclusion criteria

Inclusion criteria: 2. Patients who are type 2 diabetic for at least 5 years and on stable diabetic medication at least for a period of 3 months prior to start of study 3. Patients with HbA1c value in the range of 7 to 10 % 4. Patients with an HOMA-IR value > 4 5. End Stage Renal disease patients who are undergoing hemodialysis thrice weekly at least for a period of 3 months prior to start of study 6. Patients willing to treatment regimens and follow the study procedure

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating women 2. Patients with active gastrointestinal diseases (Inflammatory bowel disease, irritable bowel syndrome) 3. Patients who are taking or have taken probiotics or probiotics within last month prior to start of study 4. Patients who are taking antioxidants and/or anti-inflammatory supplements (Vitamin E, Vitamin C, or omega-3 fatty acids) 5. Patients who are taking immunosuppressive medication within 3 months before enrolment in the study

Design outcomes

Primary

Measure	Time frame
Change in HOMA-IR (Homeostasis Model of Assessment-estimated insulin resistance) and Oxidative stress markers (Nitric Oxide, Malondialdehyde, Glutathione)Timepoint: Baseline to 12 weeks	—

Secondary

Measure	Time frame
Change in glycemic parameters (Fasting Plasma Sugar, Glycosylated Hemoglobin) Change in Lipid Profile (Triglycerides, Total Cholesterol, High Density Lipoprotein, Low Density Lipoprotein) Incidence of adverse eventsTimepoint: Baseline to 12 weeks	—

Countries

India

Contacts

Public ContactImran Khan

Nizams Institute of Medical Sciences

drarunadonepudi@gmail.com9848923036

Outcome results

None listed

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