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The effect of probiotic on mood status and sleep quality in menopausal women

The effect of probiotic on mood status and sleep quality in menopausal women: A triple-blind randomised controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20120718010324N57
Enrollment
66
Registered
2020-06-30
Start date
2020-07-21
Completion date
Unknown
Last updated
2020-07-13

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

Conditions

Menopause. Menopausal and perimenopausal disorder, unspecified

Interventions

Intervention 1: Intervention group will consumed 100 grams of yogurt containing probiotics daily for 6 weeks. Intervention 2: Control group will consumed 100 grams of ordinary yogurt daily for 6 week

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
45 Years to 55 Years

Inclusion criteria

Inclusion criteria: Passing of one year from the last menstrual period after the onset of natural menopause Age 45-60 years Women who have been passed lower than 5 years from menopause. Not taking of sleeping drugs and antidepressants, tobacco and alcohol Obtaining anxiety score 8-19 (mild, moderate and severe anxiety), depression score between 10-27 (mild, moderate and severe depression), stress score between 15-35 (mild, moderate and severe stress) from DASS questionnaire and obtaining a score above 5 from the Pittsburgh Questionnaire. Having a contact number to follow up Being resident in Tabriz Not having digestive problems, asthma, allergies to certain plants, etc. according to the person herself Having a file in the health center (SIB system)

Exclusion criteria

Exclusion criteria: Having a history of any physical or mental illness that causes sleep disorders and depression Existence of hypothyroidism or hyperthyroidism Having a habit for caffeine consumption Experiencing an unfortunate event in the last three months, including the death of a loved one that causes sleep disorders, depression and stress

Design outcomes

Primary

MeasureTime frame
Depression, anxiety and stress. Timepoint: Before and 6 weeks after the inervention. Method of measurement: DASS-21 (Depression, Anxiety and Stress Scale-21).;Sleep quality. Timepoint: Before and 6 weeks after the intervention. Method of measurement: Pittsburgh Sleep Quality Index.

Secondary

MeasureTime frame
Quality of Life. Timepoint: Before and 6 weeks after the Intervention. Method of measurement: Menopause-specific Quality of Life Questionnaire (MENQOL).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMehrnaz Shafiee

Tabriz University of Medical Sciences

mehrnaz.sh1610@gmail.com0098 34 876954376

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 17, 2026