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Randomized, double-blind, placebo-controlled parallel-group comparative study to investigate the efficacy of synbiotics on mental health in postpartum women

Randomized, double-blind, placebo-controlled parallel-group comparative study to investigate the efficacy of synbiotics on mental health in postpartum women - Effects of ingestion of synbiotics on postpartum mental health

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000055194
Enrollment
100
Registered
2024-08-09
Start date
2024-08-15
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

None

Interventions

Ingestion of test foods for 8 weeks Ingestion of placebo foods for 8 weeks

Sponsors

Marunouchi Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Adult women who underwent a postpartum check-up after two weeks. 2. Subjects who is able to continuously intake test foods during 8 weeks.

Exclusion criteria

Exclusion criteria: 1. Subjects with a score of 9 or higher on the Edinburgh Postnatal Depression Scale, or those who scored 1 or higher on question 10. 2. Subjects with a recent history of their newborn being admitted to the Neonatal Intensive Care Unit (NICU), as well as those who have been admitted in the past. 3. Subjects who are unable to discontinue the intake of medications or over-the-counter drugs that are believed to have an impact on mental health during the trial period. 4. Subjects who are unable to discontinue the intake of oligosaccharides, probiotics (such as lactobacillus and bifidobacterium), or other similar supplements during the trial period. 5. Subjects who have participated in clinical trials of other drugs or foods within the past 6 months. 6. Subjects with a history of drug allergies or severe food allergies. 7. Subjects who are judged inappropriate to this trial by the principal investigator or co-investigator based on the subject's background, physical examination, and results of laboratory and clinical tests.

Design outcomes

Primary

MeasureTime frame
Edinburgh Postnatal Depression Scale

Countries

Japan

Contacts

Public ContactKoji Washio

Marunouchi Hospital pharmacy department

washio_k@marunouchi.or.jp0263-28-3003

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026