Effect of supplementation in treatment of patients with gestational diabetes

Clinical trial of the effect of probiotic supplementation compared with the placebo on metabolic profiles in patients with gestational diabetes

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201601035623N63

Enrollment

Registered

2016-01-03

Start date

2015-11-02

Completion date

Unknown

Last updated

2019-11-05

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

Conditions

Gestational diabetes. Diabetes mellitus in pregnancy, unspecified

Interventions

Intervention 1: Intervention group: Probiotic supplements containing three strains of Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus casei (2×109 CFU/g) and Bifidobacterium bifidum (2×109 CFU/

Eligibility

Sex/Gender

Female

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Pregnant women aged 18-40 years Diagnosed with GDM at weeks 24-28 of gestation

Exclusion criteria

Exclusion criteria: Women with preterm premature rupture of membranes Placental abruption Preeclampsia Eclampsia Hypo or hyperthyroidism A history of T2DM A family history of GDM Smokers Kidney or liver disease Taking probiotics, antibiotics or glucocorticoids Requiring insulin therapy

Design outcomes

Primary

Measure	Time frame
Insulin. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Elisa kit.;Insulin resistance. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Elisa kit.;Fasting blood sugar. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.	—

Secondary

Measure	Time frame
Triglycerides. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.;HDL-cholesterol. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.;Total cholesterol. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.;VLDL. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.;LDL. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.	—

Measure

Time frame

Triglycerides. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.;HDL-cholesterol. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.;Total cholesterol. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.;VLDL. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.;LDL. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Enzymatic kit.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactZatollah Asemi

Kashan University of Medical Sciences

asemi_z@kaums.ac.ir+98 31 5546 3378

Outcome results

None listed

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