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The effect of synbiotic supplementation on serum levels of inflammatory factors, oxidative stress, lipid profile, glycemic indices and wound healing indices in patients with diabetic foot ulcer

The effect of synbiotic supplementation on serum levels of inflammatory factors, oxidative stress, lipid profile, glycemic indices and wound healing indices in patients with diabetic foot ulcer: A double-blind randomized controlled clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230123057193N6
Enrollment
44
Registered
2025-09-17
Start date
2025-10-21
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Diabetic foot ulcers caused by uncontrolled diabetes. Type 2 diabetes mellitus with multiple complications

Interventions

Intervention 1: Intervention group: The intervention group will receive daily 2 capsules for 8 weeks containing 10^9 Cfu of bacteria (Lactobacillus rhamnosus, Lactobacillus casei, Lactobacillus acidop

Sponsors

Research assistant of Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 50 Years

Inclusion criteria

Inclusion criteria: Patients with diabetic foot ulcers grade 1 and 2 (based on Wagner-Maggett criteria) 20-60 years old 25 = BMI= 35 Informed consent.

Exclusion criteria

Exclusion criteria: Consumption antioxidant supplements such as vitamin E, vitamin C and omega-3 during the study. Consumption other probiotic, prebiotic or synbiotic supplements Conducted separately from this intervention during the study Regular consumption of other forms of probiotics (including: probiotic dairy products, probiotic yogurt, probiotic milk, buttermilk, kefir, sourdough bread, cheeses such as cream cheese, gouda, cheddar, Sausage, Gruyere and other dairy products, types of vinegar and food items containing them. Becoming pregnant Taking antidepressants

Design outcomes

Primary

MeasureTime frame
ESR. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA assay.;CRP. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA assay.

Secondary

MeasureTime frame
MDA. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA assay.;FBS. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA assay.;Quicki test. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA assay.;Wound dimensions (length, width, and depth of the wound). Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA assay.;TG. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA assay.;TOTAL chol. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA assay.;HDL. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA assay.;LDL. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA assay.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSorayia Ebrahimpour Koujan

Tehran University of Medical Sciences

nutri.seam1@gmail.com+98 21 5563 0553

Outcome results

None listed

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