N94.6
Conditions
Interventions
Group 1: Intake of probiotics for approximately 12 weeks.
Group 2: Intake of placebos for approximately 12 weeks.
Sponsors
Hochschule für Angewandte Wissenschaften Coburg
Eligibility
Sex/Gender
Female
Age
18 Years to 30 Years
Inclusion criteria
Inclusion criteria: • Age between = 18 years and = 30 years; primary dysmenorrhea affects women of reproductive age, with 70-90% of affected women being under 24 years old (Itani et al., 2022; Segerer, 2020). • At least moderate dysmenorrhea during the last 3 periods, with an average pain score of = 4 on a scale of 0-10 (0 = no pain, 10 = worst imaginable pain) (Ameade, 2016; Margueritte et al., 2024) • Primary dysmenorrhea with no known medical cause for the pain • Sufficient knowledge of the German language to answer the questionnaires • Consent to participate in the study and data collection (via scan) • No exclusion criteria are met
Exclusion criteria
Exclusion criteria: • Participants with a high risk of endometriosis, defined as a score of 25 or higher according to Chapron et al. (2022) • Use of psychotropic medications and/or manifest psychiatric conditions (e.g., recurrent depression, generalized anxiety disorder, addiction) • Individuals taking immunosuppressive drugs (e.g., after organ or stem cell transplantation, autoimmune diseases, or cancer treatment), suffering from structural heart diseases (e.g., heart valve abnormalities, heart valve replacement, infective endocarditis), active intestinal disease or perforation, neutropenia, or currently hospitalized (Doron & Snydman, 2015; Maftei et al., 2024; Sen, 2019) • Pregnancy or breastfeeding (Doron & Snydman, 2015; Maftei et al., 2024; Sen, 2019) • Use of hormonal contraceptives (during the last three periods) • Use of another investigational drug within 3 months prior to screening • Use of antibiotics or probiotic supplements within 1 month prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Group differences in pre-post changes will be assessed in: - Dysmenorrhea Daily Diary (DysDD) - Physical and mental health-related quality of life (SF-12) - Perceived stress (PSS-10) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Sociodemographic data - Medical data - Treatment expectation (TEX-Q) - Menstrual pain (DSF) - Menstrual stress (MEDI-Q) - Depression, anxiety, and stress (DASS) - Physical sensations (Hannover Body Template) | — |
Countries
Germany
Contacts
Public ContactKarin Meißner
Hochschule für angewandte Wissenschaften Coburg
Outcome results
None listed