Effect of supplementation in treatment of women with gestational diabetes

Clinical trial of the effect of probiotic supplementation compared with the placebo on pregnancy outcomes in women with gestational diabetes

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201611115623N91

Enrollment

Registered

2016-11-23

Start date

2016-04-07

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 capsule containing four strains of Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus casei (2×109 CFU/g) and Bifidobacterium bifidum (2×109 CFU/g) (T

Eligibility

Sex/Gender

Female

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Patients with gestational diabetes Aged 18 to 40 years.

Exclusion criteria

Exclusion criteria: Placenta abruption Pre-eclampsia Eclampsia Hypo and hyperthyroidism Urinary tract infection Smokers Kidney or liver diseases Insulin therapy during intervention

Design outcomes

Primary

Measure	Time frame
Hs-CRP. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Elisa kit.;Nitric oxide. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Spectrophotometry.	—

Secondary

Measure	Time frame
Total antioxidant. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Spectrophotometry.;Malondialdehyde. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Spectrophotometry.;Newborns' weight. Timepoint: The first 24 h after birth. Method of measurement: Scale.;Newborns' length. Timepoint: The first 24 h after birth. Method of measurement: Girth measuring tape.;Newborns' head circumference. Timepoint: The first 24 h after birth. Method of measurement: Girth measuring tape.;Polyhydramnios. Timepoint: Post-intervention. Method of measurement: Sonography.;Newborn's head circumference. Timepoint: Delivery time. Method of measurement: Tape.;Newborn's bilirubin. Timepoint: Delivery time. Method of measurement: Enzymatic kit.;Apgar score. Timepoint: Delivery time. Method of measurement: Clinical observation.;Newborns' hypoglycemia. Timepoint: After delivery. Method of measurement: Enzymatic kit.;Preterm delivery. Timepoint: After delivery. Method of measurement: Medical record.;Maternal pre-eclampsia. Timepoint: After delivery. Method of measurement: Medical record.;Newborns' hospitalization. Timepoint: After delivery. Method of measurement: Medical record.	—

Measure

Time frame

Total antioxidant. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Spectrophotometry.;Malondialdehyde. Timepoint: At the beginning of the study and after 6 weeks of intervention. Method of measurement: Spectrophotometry.;Newborns' weight. Timepoint: The first 24 h after birth. Method of measurement: Scale.;Newborns' length. Timepoint: The first 24 h after birth. Method of measurement: Girth measuring tape.;Newborns' head circumference. Timepoint: The first 24 h after birth. Method of measurement: Girth measuring tape.;Polyhydramnios. Timepoint: Post-intervention. Method of measurement: Sonography.;Newborn's head circumference. Timepoint: Delivery time. Method of measurement: Tape.;Newborn's bilirubin. Timepoint: Delivery time. Method of measurement: Enzymatic kit.;Apgar score. Timepoint: Delivery time. Method of measurement: Clinical observation.;Newborns' hypoglycemia. Timepoint: After delivery. Method of measurement: Enzymatic kit.;Preterm delivery. Timepoint: After delivery. Method of measurement: Medical record.;Maternal pre-eclampsia. Timepoint: After delivery. Method of measurement: Medical record.;Newborns' hospitalization. Timepoint: After delivery. Method of measurement: Medical record.

—

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