Effect of supplementation therapy in treatment of women with gestational diabetes

Clinical trial of the effect of synbiotic 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

IRCT201704205623N108

Enrollment

Registered

2017-04-27

Start date

2016-04-19

Completion date

Unknown

Last updated

2019-12-17

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: Control group: Placebo oral capsule (Tak Gen Zist, Tehran, Iran), daily, for 6 weeks. Intervention 2: Intervention group: Synbiotic oral capsule containing three strains of Lactobacill

Eligibility

Sex/Gender

Female

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Pregnant women aged 18-40 years with gestational diabetes mellitus at 24-28 weeks' gestation

Exclusion criteria

Exclusion criteria: Pre-eclampsia Eclampsia Hypo and hyperthyroidism Kidney or liver diseases Taking any probiotic and/or synbiotic products Smoker Insulin therapy after GDM diagnosis

Design outcomes

Primary

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

Measure

Time frame

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

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZatollah Asemi

Kashan University of Medical Sciences

asemi_r@yahoo.com+98 31 5546 3378

Outcome results

None listed

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