The Influence of Seasonal Variations in Clinical Trials Based on Gut Microbiota Studies.
| Title: | The Influence of Seasonal Variations in Clinical Trials Based on Gut Microbiota Studies. |
|---|---|
| Authors: | Cocomazzi G; Gastroenterology Unit, Fondazione IRCCS 'Casa Sollievo della Sofferenza' Hospital, Viale dei Cappuccini 1, 71013 San Giovanni Rotondo, Italy.; Panebianco C; Gastroenterology Unit, Fondazione IRCCS 'Casa Sollievo della Sofferenza' Hospital, Viale dei Cappuccini 1, 71013 San Giovanni Rotondo, Italy.; Vallelunga A; Studio Vallelunga-Functional Nutrition, Via Manara 11, 04019 Terracina, Italy.; De Ruvo D; Gynaecology, Obstetrics and Reproductive Medicine Affidea Promea, Via Menabrea 14, 10126 Torino, Italy.; Del Pup L; Gynecological Endocrinology and Fertility, University Sanitary Agency Friuli Central (ASUFC), Via San Valentino 18, 33100 Udine, Italy.; Smeazzetto S; NEXT Genomics Srl, 50019 Sesto Fiorentino, Italy.; Antinori M; Raprui Clinic, Via Timavo, 2, 00195 Roma, Italy.; Chimienti V; VMC-OsteoKinetic Studio, Via Roma, 26/a, 20096 Pioltello, Italy.; Maggio G; Pia Fondazione Cardinale Giovanni Panico, Via S. Pio X, 4, 73039 Tricase, Italy.; Finocchiaro C; Integrative Medicine Unit, Humanitas Gradenigo, Corso Regina Margherita 8/10, 10153 Torino, Italy.; Contu V; Integrative Medicine Unit, Humanitas Gradenigo, Corso Regina Margherita 8/10, 10153 Torino, Italy.; Pazienza V; Gastroenterology Unit, Fondazione IRCCS 'Casa Sollievo della Sofferenza' Hospital, Viale dei Cappuccini 1, 71013 San Giovanni Rotondo, Italy. |
| Source: | Microorganisms [Microorganisms] 2025 Oct 17; Vol. 13 (10). Date of Electronic Publication: 2025 Oct 17. |
| Publication Type: | Journal Article; Review |
| Language: | English |
| Journal Info: | Publisher: MDPI AG Country of Publication: Switzerland NLM ID: 101625893 Publication Model: Electronic Cited Medium: Print ISSN: 2076-2607 (Print) Linking ISSN: 20762607 NLM ISO Abbreviation: Microorganisms Subsets: PubMed not MEDLINE |
| Imprint Name(s): | Original Publication: Basel, Switzerland : MDPI AG, [2013]- |
| Abstract: | Seasonality is a key determinant in shaping the composition and function of the human gut microbiota, exerting its influence through multiple interconnected factors. These include seasonal variations in diet, environmental conditions (such as temperature, humidity, and sunlight exposure), behavioral patterns (physical activity, time spent outdoors), and the incidence of seasonal infections. These changes are most visible in certain populations where food availability follows a seasonal pattern. Increasing evidence suggests that gut microbiota composition undergoes seasonal variations, which may have significant implications for human health. In patients with non-communicable chronic diseases (NCDs), where microbiota dysbiosis plays a crucial role in disease progression, understanding the seasonal effects on gut microbiota is essential. These dynamic changes impact the gut microbiota immune system interaction and may contribute to the onset or exacerbation of various diseases, including chronic inflammatory, metabolic, and autoimmune disorders. Most clinical trials on probiotics do not consider seasonality as a confounding variable, which could impact the interpretation of results and therapeutic efficacy, potentially biasing estimates of intervention efficacy or associations with disease. This review examines the current evidence on gut microbiota seasonality, discusses its potential bias, and outlines methodological considerations for future clinical trials. |
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| Grant Information: | Ricerca Corrente Program 2023-2025 Italian Ministry of Health; IG 2019-ID. 23006 project Italian Association for Cancer Research |
| Contributed Indexing: | Keywords: dietary; gut microbiota; non-communicable chronic diseases; seasonality |
| Entry Date(s): | Date Created: 20251029 Date Completed: 20251029 Latest Revision: 20251101 |
| Update Code: | 20260130 |
| PubMed Central ID: | PMC12566549 |
| DOI: | 10.3390/microorganisms13102386 |
| PMID: | 41156845 |
| Database: | MEDLINE |
Journal Article; Review