Adjuvant administration probiotic effects on sexual function in depressant men undergoing selective serotonin reuptake inhibitor treatment: a double-blinded randomized controlled trial.

BACKGROUND: Depression is a common psychiatric disorder worldwide, often linked to complications like impaired sexual function. AIM: To determine the effect of the probiotic Lactofem combined with Escitalopram on severity of depression and sexual function in men diagnosed with mild to moderate depression undergoing SSRI treatment. METHODS: In a randomized controlled trial, 240 men with mild to moderate depression were assigned to 2 groups. The intervention group (119 participants) received Lactofem alongside Escitalopram, while the control group (121 participants) received only Escitalopram for 2 months. OUTCOMES: Depression severity was measured by the Hamilton Depression Rating Scale (HDRS) and Beck Depression Inventory (BDI). Sexual function was assessed using the International Index of Erectile Function (IIEF) questionnaire at baseline and after treatment. RESULTS: Both groups showed significant improvement in depression scores (P < .05). The Lactofem group had a greater reduction in HDRS (6.42 ± 3.45 vs 8.61 ± 4.15, P < .05) and BDI scores (27.63 ± 4.13 vs 30.24 ± 4.51, P < .05). Sexual function improvements were significantly higher in the intervention group across all domains: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction (all P < .05). CLINICAL IMPLICATIONS: Probiotics such as Lactofem may offer benefits as adjunctive therapy to reduce depression symptoms and improve SSRI-induced sexual dysfunction. STRENGTHS AND LIMITATIONS: Strengths include a rigorous randomized design, validated tools, and large sample size. Limitations are recruitment from a single Iranian clinic with culturally homogenous, married men, absence of placebo, young patient age, and no long-term follow-up. CONCLUSION: Adding Lactofem to Escitalopram treatment significantly reduces depression severity and enhances sexual function in men with mild to moderate depression. CLINICAL TRIAL NUMBER: IRCT20160524028038N14, Registration Date: 2024-05-17. TRIAL REGISTRATION: ClinicalTrials.gov identifier: https://irct.behdasht.gov.ir/trial/67103.