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The effect of synbiotic supplementation and psychobiotic diet on depression and anxiety during pregnancy in women with gestational diabetes

The effect of synbiotic supplementation and psychobiotic diet on depression and anxiety during pregnancy in women with gestational diabetes: A three-group controlled clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220926056046N7
Enrollment
102
Registered
2025-12-05
Start date
2025-12-22
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Condition 1: Anexity during pregnancy. Condition 2: Depression during pregnancy. Puerperal psychosis Puerperal psychosis

Interventions

Intervention 1: For sampling from health centers, first the number of eligible pregnant women covered by each selected center will be determined using the SEB system. Then, through reviewing medical r

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Women with a gestational age of 24-28 weeks or higher and diagnosed with gestational diabetes visiting health centers in the city of Tabriz (urban and suburban centers) as well as Taleghani, Al-Zahra, 29 Bahman clinics and obstetricians' clinics and offices

Exclusion criteria

Exclusion criteria: Women with known diabetes / major recognized diseases including heart, pregnancy hypertension, preeclampsia, liver / major known fetal abnormalities / known psychiatric disorder

Design outcomes

Primary

MeasureTime frame
Pregnancy-related disorders. Timepoint: Before intervention and at 38 weeks of pregnancy. Method of measurement: Revised Pregnancy Related Anxiety Questionnaire: R-PRAQ.;Depression during pregnancy. Timepoint: Before intervention and at 38 weeks of pregnancy. Method of measurement: Edinburgh Postpartum Depression Scale (EPDS).

Secondary

MeasureTime frame
Postpartum depression. Timepoint: Before intervention and 4-6 weeks after delivery. Method of measurement: Edinburgh Postpartum Depression Scale (EPDS).;Postpartum Anxiety. Timepoint: Before intervention and 4-6 weeks after delivery. Method of measurement: PSAS-RSF = Postpartum Specific Anxiety Scale-Research Short-Form.;Some maternal and neonatal outcomes. Timepoint: Immediately after childbirth. Method of measurement: Mother and baby medical record.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSolmaz Ghanbari Homaie

Tabriz University of Medical Sciences

homayisolmaz@gmail.com+98 41 3477 0648

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Sep 18, 2026