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Probiotic supplementation for maternal depression

Effect of probiotic supplementation on maternal depression, anxiety and attachment in gestational diabetes by improving Mediterranean diet quality: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN96215615
Enrollment
64
Registered
2024-02-02
Start date
2022-11-30
Completion date
Unknown
Last updated
2024-02-27

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

Conditions

Mental health in individuals with gestational diabetes Mental and Behavioural Disorders

Interventions

With an allocation ratio of 1:1, the participants were divided into two groups: the control group, receiving a standard diet compatible with the Mediterranean diet (MD), and a probiotic supplementatio

Sponsors

Eastern Mediterranean University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Pregnant women 2. Aged between 20 and 40 years 3. Diagnosed with GDM 4. Had complete data 5. Agreed to participate in the study

Exclusion criteria

Exclusion criteria: 1. Multiple pregnancies 2. Prenatal diagnosis of diabetes mellitus 3. Hypertensive disorders 4. Chronic diseases such as liver and/or kidney disease 5. Body mass index (BMI) of =30 kg/m2 or <18.5 kg/m2 6. Presence of abnormal fetal structures or chromosomal findings based on second-trimester ultrasound screening and/or invasive prenatal diagnosis 7. Planned pregnancy termination 8. Diagnosis of a psychiatric illness 9. Presence of intrauterine growth restriction (IUGR) complication in GDM diagnosis 10. Insulin therapy after GDM diagnosis 11. Requirement for special dietary intervention (severe food allergy) 12. Receiving probiotic supplementation 13. Sleep problems 14. Stressful events 15. Sedentary physical activity

Design outcomes

Primary

MeasureTime frame
1. Mother's pre-pregnancy body mass index obtained retrospectively from routine gynecologist examination records 2. Body weight measured using Tanita BC 545 N bioelectric impedance device-BIA at the 24th week of pregnancy 3. Participants' sociodemographic data, medical history, and pregnancy data recorded at the 24th week of gestation (at the beginning of the intervention): a record was kept with a questionnaire during the routine gynecologist examination 4. The mother's prenatal depression level was measured using the Edinburgh Postnatal Depression Scale (EPDS) at the beginning (24th week of gestation) and at the end (36th week of gestation) of the study 5. Prenatal anxiety level was measured using the Pregnancy-Related Anxiety Scale (PrAS) at the beginning (24th week of pregnancy) and at the end (36th week of pregnancy) of the study 6. The mother's attachment level was measured using the Prenatal Maternal Attachment Scale (MAAS) at the beginning (24th week of gestation) and at the end (36th week of gestation) of the study

Secondary

MeasureTime frame
Mediterranean diet score measured using the MedDiet scoring system at the 24th and the 36th week of pregnancy

Countries

Turkey

Contacts

Public ContactFatma Bengü Kuyulu Bozdogan
f.bengukuyulu@gmail.com+357 (0)5061497807

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 5, 2026