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Effect of probiotic supplements on patients with type 2 diabetes

The effect of Familact probiotic supplementation on lipid profile, glycemic control and insulin levels in patients with type 2 diabetes

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013100714925N1
Enrollment
60
Registered
2013-11-09
Start date
2013-07-11
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 2 Diabetes. Non-insulin-dependent diabetes mellitus

Interventions

Intervention 1: Intervention Group: Patients with type 2 Diabetes receive 2 Familact Probiotic Capsules twice per day (After lunch and after dinner), for 6 weeks. Each capsule contains 500 mg Probioti
Treatment - Drugs
Placebo
Intervention Group: Patients with type 2 Diabetes receive 2 Familact Probiotic Capsules twice per day (After lunch and after dinner), for 6 weeks. Each capsule contains 500 mg Probiotics which precise
Placebo Group: Receiving 2 Placebo Capsules twice per day (after lunch and dinner), containing 1000 mg Magnesium Stearate for 6 weeks.

Sponsors

Vice chancellor of Shahid Beheshti Endocrinology Research center
Lead Sponsor
Vice chancellor of Qazvin University of Medical Sciences
Collaborator

Eligibility

Sex/Gender
All
Age
25 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Having type 2 diabetes mellitus; the age range was 25 to 65 years with a fifteen-year maximal period of type 2 diabetes mellitus ; controlled glucose and lipid levels of the patients were considered ; taking drugs prescribed by doctors were permitted until their dosages were unchanged during the intervention. Exclusion criteria: Having replacement treatments like Hormone or supplemental vitamins ; tobacco and alcohol use ; clinical signs of chronic kidney, liver or pulmonary disease ; chronic or acute inflammatory disease (especially acute pancreatic inflammation and Endocarditis) ; heart valve disease ; short bowel syndrome ; allergies ; immunosuppressives ; pregnancy and lactation and taking less than 10% of probiotic or placebo supplements.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Fasting Blood Sugar. Timepoint: Baseline, and after 6 weeks. Method of measurement: Biochemical Analysis.;Serum Insulin. Timepoint: Baseline and after 6 weeks. Method of measurement: ELIZA.;HOMA-IR. Timepoint: Baseline and after 6 weeks. Method of measurement: Formula.;Lipid profile: Total cholesterol, Triglyceride, HDL-C, LDL-C. Timepoint: Baseline and after 6 weeks. Method of measurement: Biochemical Analysis.

Secondary

MeasureTime frame
Dietary Factors. Timepoint: Baseline and after 6 weeks. Method of measurement: 24 hour and 3-day dietary Recall.;Body Mass Index. Timepoint: Baseline and after 6 weeks. Method of measurement: Formula.;Waist Circumference. Timepoint: Baseline and after 6 weeks. Method of measurement: Inelastic Plastic Tape.;Hip Circumference. Timepoint: Baseline and after 6 weeks. Method of measurement: Inelastic Plastic Tape.;Waist to Hip Ratio. Timepoint: Baseline and after 6 weeks. Method of measurement: Formula.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Parvin Mirmiran

Shahid Beheshti Endocrinology Research Center

mirmiran@endocrine.ac.ir+98 21 2243 2500

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Mar 5, 2026