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Pro-biotic on inflammation factors in patients with type 2 diabetes mellitus

The effects of pro-biotic on inflammation factors in patients with type 2 diabetes mellitus

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014110519816N1
Enrollment
44
Registered
2015-02-03
Start date
2015-01-17
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

Type II diabetes mellitus. Non-insulin-dependent diabetes mellitus

Interventions

Intervention 1: supplementation tablet probiotic in intervention group: Each probiotic tablet is comprised of 100 mg Lactol probiotic. Lactol probiotic include Lactobacillus coagulans and Fructooligos
Treatment - Drugs
Placebo
supplementation tablet probiotic in intervention group: Each probiotic tablet is comprised of 100 mg Lactol probiotic. Lactol probiotic include Lactobacillus coagulans and Fructooligosaccharides (FOS)
placebo in control group: Each placebo tablet contained farina. Placebo tablets were produced by Pharmaceutics department of Mashhad School of Pharmacy.

Sponsors

Sabzevar University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: patients affected to diabetes melitus type 2; body mass index <35 kg/m2; patients enrolled in this study should have no infectious disease, hepatitis or renal diseases. Exclusion criteria: patients received cholesterol-lowering drugs, probiotic, prebiotic and omega-3 fatty acids and antibiotics from 1 month before and during the study.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Inflammation factors (CRP, IL-6 and TNF). Timepoint: Baseline (before initiating intervention) and 8 weeks after initiating intervention. Method of measurement: Enzyme-like immune- sorbent assay (ELISA) kits (Monobind, Inc., Lake Forest, Calif., USA).

Secondary

MeasureTime frame
Serum lipid profile (LDL, HDL, total). Timepoint: Baseline and the end of week 8. Method of measurement: Kits of Pars Test company and Auto analyzer Selectra 2 methods.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactBibi Leila Hoseini

Sabzevar University of Medical Sciences

hoseinil871@gmail.com+98 51 4441 9573

Outcome results

None listed

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