Effect of Probiotics on diabetes mellitus arising in pregnancy

Effect of Probiotics in comparison with placebo on glucose metabolism, weight changes and inflammatory and oxidative stress indices in women with gestational diabetes mellitus

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT201405181597N3

Enrollment

Registered

2014-06-16

Start date

2014-05-29

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

Gestational Diabetes Mellitus. Diabetes mellitus arising in pregnancy

Interventions

Intervention 1: Control: in control group, 32 pregnant women after the entry qualifications, will take one tablet of placebo with the shape and color exactly similar to 4biocap for 8 weeks and variabl

Treatment - Drugs

Control: in control group, 32 pregnant women after the entry qualifications, will take one tablet of placebo with the shape and color exactly similar to 4biocap for 8 weeks and variables will be analy

Intervention: in intervention group, 32 pregnant women after the entry qualifications will take one capsule of 4biocap? containing 180 mg(>1 billion CFU) of a standardized, cream colored powder consis

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Inclusion criteria: nulliparity; diagnosis of gestational diabetes mellitus between 24 weeks and 0 days and 28 weeks and 6 days of pregnancy with oral screening test; fasting blood glucose level between 92- 126 mg/dl; body mass index 18.5 and more; nulliparity; negative history of f diabetes mellitus before the current pregnancy; chronic diseases; Smoking and/or alcohol consumption; probiotic food products consumption through current 2 weeks; antibiotic usage through current month; acute GI condition through current month and glucocorticoid and immunosuppressor drugs usage Exclusion criteria: need for insulin or other hypoglycemic drugs; corticosteroids or immune-suppressants usage or acute GI condition during the study

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Fasting Blood Glucose. Timepoint: Before and after intervention. Method of measurement: Enzymatic.;Fasting Plasma Insulin. Timepoint: Before and after intervention. Method of measurement: Elisa.;Homeostatic Model Assessment/HOMA-IR. Timepoint: Before and after intervention. Method of measurement: Calculation.;Quantitative Insulin Sensitivity Check/QUICKI-index. Timepoint: Before and after intervention. Method of measurement: Calculation.	—

Measure

Time frame

Fasting Blood Glucose. Timepoint: Before and after intervention. Method of measurement: Enzymatic.;Fasting Plasma Insulin. Timepoint: Before and after intervention. Method of measurement: Elisa.;Homeostatic Model Assessment/HOMA-IR. Timepoint: Before and after intervention. Method of measurement: Calculation.;Quantitative Insulin Sensitivity Check/QUICKI-index. Timepoint: Before and after intervention. Method of measurement: Calculation.

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Secondary

Measure	Time frame
Highly Sensitive-C Reactive Protein/hs-CRP. Timepoint: Before and after intervention. Method of measurement: Elisa.;Tumor Necrozing Factor Alpha/TNF-a. Timepoint: Before and after intervention. Method of measurement: Elisa.;Interleukine-6. Timepoint: Before and after intervention. Method of measurement: Elisa.;Toatal Antioxidant Capacity/TAC. Timepoint: Before and after intervention. Method of measurement: Elisa.;Malondialdehyde/MDA. Timepoint: Before and after intervention. Method of measurement: Enzymatic.;Glutathione Reductase/GSH-Red. Timepoint: Before and after intervention. Method of measurement: Elisa.;Superoxide Dismutase/SOD. Timepoint: Before and after intervention. Method of measurement: Elisa.;Glutathione Peroxidase/GSH-Px. Timepoint: Before and after intervention. Method of measurement: Enzymatic.;Uric Acid. Timepoint: Before and after intervention. Method of measurement: Enzymatic.;Weight. Timepoint: Before, 2 weeks, 4 weeks, 6 weeks and 8 weeks after intervention. Method of measurement: Digital scale.	—

Measure

Time frame

Highly Sensitive-C Reactive Protein/hs-CRP. Timepoint: Before and after intervention. Method of measurement: Elisa.;Tumor Necrozing Factor Alpha/TNF-a. Timepoint: Before and after intervention. Method of measurement: Elisa.;Interleukine-6. Timepoint: Before and after intervention. Method of measurement: Elisa.;Toatal Antioxidant Capacity/TAC. Timepoint: Before and after intervention. Method of measurement: Elisa.;Malondialdehyde/MDA. Timepoint: Before and after intervention. Method of measurement: Enzymatic.;Glutathione Reductase/GSH-Red. Timepoint: Before and after intervention. Method of measurement: Elisa.;Superoxide Dismutase/SOD. Timepoint: Before and after intervention. Method of measurement: Elisa.;Glutathione Peroxidase/GSH-Px. Timepoint: Before and after intervention. Method of measurement: Enzymatic.;Uric Acid. Timepoint: Before and after intervention. Method of measurement: Enzymatic.;Weight. Timepoint: Before, 2 weeks, 4 weeks, 6 weeks and 8 weeks after intervention. Method of measurement: Digital scale.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactNeda Dolatkhah

Shahid Beheshti University of Medical Sciences and Health Services

neda_dolatkhah@yahoo.com+98 218820902021

Outcome results

None listed

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