Effects of Probiotic Supplementation on Depressive Symptoms, Sleep Quality, and Modulation of Gut Microbiota and Inflammatory Biomarkers: A Randomized Controlled Trial
Abstract
Background: More than merely determining our sleep pattern, our body’s internal clock also improves the quality of our sleep, alleviates the symptoms of depression, and maintains the balance of our gut flora. Methods: We carried out a 12-week randomized controlled trial with 99 adults from Kolkata, New Delhi, and Pune who reported sleep problems and symptoms of depression or anxiety. Participants received either a probiotic formulated to improve sleep quality and reduce depressive symptoms or a placebo. We tracked sleep using overnight studies and wearable devices, assessed depressive symptoms with standardized questionnaires, and analyzed stool samples to profile gut bacteria and their metabolites using gene sequencing and metabolomics. Advanced statistics and machine learning helped us pinpoint the key microbial and metabolic factors tied to sleep and mental health. Results: At the start, participants with disrupted sleep and depressive symptoms had fewer beneficial gut bacteria like Bifidobacterium and Lactobacillus, more inflammation-related microbes, and lower levels of helpful short-chain fatty acids. These imbalances were linked to poorer sleep efficiency, less REM sleep, and higher depression and anxiety scores. After 12 weeks, those taking the circadian-supporting probiotic saw a statistically significant increase in beneficial gut bacteria, improved sleep efficiency (+7.4%, p = 0.02), and greater reductions in depression and anxiety compared to the placebo.…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 99 participants or records.
Read the paper
Related studies
- Improving the translation of search strategies using the Polyglot Search Translator: a randomized controlled trial
- Nutritional, Physical, Cognitive, and Combination Interventions and Frailty Reversal Among Older Adults: A Randomized Controlled Trial
- Clinical characteristics and risk factors associated with COVID-19 severity in patients with haematological malignancies in Italy: a retrospective, multicentre, cohort study
- A randomized, controlled trial of oral propranolol in infantile hemangioma
- Clinical phenotypes of delirium during critical illness and severity of subsequent long-term cognitive impairment: a prospective cohort study
- Increased physical activity improves sleep and mood outcomes in inactive people with insomnia: a randomized controlled trial
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.