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Efficacy of Adjunct PRObiotics as Compared to the Standard Care in Moderate Unipolar Depression Among Geriatric Patients: A Randomized Double-Blind Placebo-Controlled Pilot Multi-Center Trial (PRODG)

To evaluate the efficacy of adjunct probiotic supplementation (Lactobacillus helveticus and Bifidobacterium longum) alongside standard care compared to placebo in older adults with moderate unipolar depression. A randomized, double-blind, placebo-con...

Body Mind StateJune 17, 20261 min read
Efficacy of Adjunct PRObiotics as Compared to the Standard Care in Moderate Unipolar Depression Among Geriatric Patients: A Randomized Double-Blind Placebo-Controlled Pilot Multi-Center Trial (PRODG)

Key Findings

To evaluate the efficacy of adjunct probiotic supplementation (Lactobacillus helveticus and Bifidobacterium longum) alongside standard care compared to placebo in older adults with moderate unipolar depression. A randomized, double-blind, placebo-controlled pilot trial was conducted at two tertiary centers. Fifty-eight participants (≥ 60 years) with moderate depression were randomized 1:1 to receive daily probiotics or a placebo for 12 weeks, alongside standard antidepressant care. They were followed up for another 12 weeks. The primary outcome was depression response (≥ 50% Montgomery-Åsberg Depression Rating Scale [MADRS] score reduction). Secondary outcomes included anxiety (General Anxiety Disorder 7-Item [GAD-7]), cognition, quality of life (WHOQOL-BREF), serum brain-derived neurotropic factor (BDNF), and gut microbiota profile. Mixed-effects models showed significant improvement over time in depressive symptoms (MADRS: F = 32.0, p < 0.001) and anxiety (GAD-7: F = 13.1, p < 0.001). Overall scores were lower in the probiotic group compared with the placebo group for both MADRS (F = 12.7, p = 0.001) and GAD-7 (F = 10.7, p = 0.002), although group × time interactions were not significant. Quality-of-life domains improved markedly (all F > 100, p < 0.001) without additional benefit from probiotics. Escitalopram-equivalent antidepressant dose and benzodiazepine use influenced selected outcomes. The probiotic group also had a significantly higher serum BDNF level and increased fecal abundance of supplemented strains vs. the placebo group. The attrition rate was > 50% over 24 weeks. In this pilot PRODG trial, adjunct probiotics produced modest overall advantages for depressive and anxiety symptoms compared with placebo but did not enhance quality-of-life beyond usual improvement - both groups improved substantially, and trajectories over 24 weeks were largely parallel across follow-up.

Why This Matters for Body-Mind Practice

[Draft — editorial context needed]

Source

Original Publication
Journal of the American Geriatrics Society
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