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Treatment of Relapsing Mild-to-Moderate Ulcerative Colitis With the Probiotic VSL#3 as Adjunctive to a Standard Pharmaceutical Treatment: A Double-Blind, Randomized, Placebo-Controlled Study
Open accessAbstract
OBJECTIVES: VSL#3 is a high-potency probiotic mixture that has been used successfully in the treatment of pouchitis. The primary end point of the study was to assess the effects of supplementation with VSL#3 in patients affected by relapsing ulcerative colitis (UC) who are already under treatment with 5-aminosalicylic acid (ASA) and/or immunosuppressants at stable doses. METHODS: A total of 144 consecutive patients were randomly treated for 8 weeks with VSL#3 at a dose of 3,600 billion CFU/day (71 patients) or with placebo (73 patients). RESULTS: In all, 65 patients in the VSL#3 group and 66 patients in the placebo group completed the study. The decrease in ulcerative colitis disease activity index (UCDAI) scores of 50% or more was higher in the VSL#3 group than in the placebo group (63.1 vs. 40.8; per protocol (PP) P=0.010, confidence interval (CI)₉₅(%) 0.51-0.74; intention to treat (ITT) P=0.031, CI₉₅(%) 0.47-0.69). Significant results with VSL#3 were recorded in an improvement of three points or more in the UCDAI score (60.5% vs. 41.4%; PP P=0.017, CI₉₅(%) 0.51-0.74; ITT P=0.046, CI₉₅(%) 0.47-0.69) and in rectal bleeding (PP P=0.014, CI₉₅(%) 0.46-0.70; ITT P=0.036, CI₉₅(%) 0.41-0.65), whereas stool frequency (PP P=0.202, CI₉₅(%) 0.39-0.63; ITT P=0.229, CI₉₅(%) 0.35-0.57), physician's rate of disease activity (PP P=0.088, CI₉₅(%) 0.34-0.58; ITT P=0.168, CI₉₅(%) 0.31-0.53), and endoscopic scores (PP P=0.086, CI₉₅(%) 0.74-0.92; ITT P=0.366, CI₉₅(%) 0.66-0.86) did not show statistical differences. Remission was higher in the VSL#3 group than in the placebo group (47.7% vs. 32.4%; PP P=0.069, CI₉₅(%) 0.36-0.60; ITT P=0.132, CI₉₅(%) 0.33-0.56). Eight patients on VSL#3 (11.2%) and nine patients on placebo (12.3%) reported mild side effects. CONCLUSIONS: VSL#3 supplementation is safe and able to reduce UCDAI scores in patients affected by relapsing mild-to-moderate UC who are under treatment with 5-ASA and/or immunosuppressants. Moreover, VSL#3 improves rectal bleeding and seems to reinduce remission in relapsing UC patients after 8 weeks of treatment, although these parameters do not reach statistical significance.
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“In IBD, the probiotic mixture VSL#3, which contains bifidobacteria of different species, was able to reduce the UC symptoms in adults (144, 145) as well as the remission of the disease in children (84).”
From Bifidobacteria and Their Health-Promoting Effects (2017) · cites this paper as [145]
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“Both demonstrate that high doses improve disease activity scores”
From The gut microbiota and host health: a new clinical frontier (2016) · cites this paper as [74]
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An introduction of the role of probiotics in human infections and autoimmune diseases
Sales‐Campos, H., Soares, S. D. C., & Oliveira, C. J. F. (2019) · Critical Reviews in Microbiology · doi:10.1080/1040841x.2019.1621261 · Cited by 52
“#3 at a dose of 3.6 109 CFU/day for 8weeks, showed the effectiveness of this supplementation to reduce clinical scores (Figure 2) (Tursi et al. 2010).”
BackgroundInfluentialBamola, V. D., Dubey, D., Samanta, P., Kedia, S., Ahuja, V., Madempudi, R. S., Neelamraju, J., & Chaudhry, R. (2022) · Anaerobe · doi:10.1016/j.anaerobe.2022.102652 · Cited by 56
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Probiotics and Antibiotics in IBD
Sokol, H. (2014) · Digestive Diseases · doi:10.1159/000367820 · Cited by 48
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Probiotics in Gastroenterology: How Pro Is the Evidence in Adults?
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Lactobacillus plantarum CBT LP3 ameliorates colitis via modulating T cells in mice
Kim, D. H., Kim, S., Ahn, J. B., Kim, J. H., Woo, H. J., Seo, D. H., Che, X., Park, K. C., Jeon, J. Y., Kim, S. Y., et al. (2020) · International Journal of Medical Microbiology · doi:10.1016/j.ijmm.2020.151391 · Cited by 48
“Indeed, recent studies suggest that probiotics have the ability to ameliorate abnormal immune responses and have potential benefits in IBD, although conflicting results have been observed in clinical use (Dignass et al., 2012; Ganji-Arjenaki and Rafieian-Kopaei, 2018; Tursi et al., 2010).”
ResultGut microbiota and inflammatory bowel disease: the role of antibiotics in disease management
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Pollutants, microbiota and immune system: frenemies within the gut
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Self-citationGut Microbiota, Probiotics and Inflammatory Bowel Disease
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Might patients with immune-related diseases benefit from probiotics?
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Comparative genomic analysis of the multispecies probiotic-marketed product VSL#3
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“Significant improvement by VSL#3 of disease symptoms were observed in the treatment of ulcerative colitis and pouchitis, an inflammation of the ileal pouch in colectomy patients [24,32].”
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Microbe-metabolite-host axis, two-way action in the pathogenesis and treatment of human autoimmunity
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Fecal Microbiota Transplantation: From Clostridium difficile to Inflammatory Bowel Disease.
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“The specific index and severity of the disease in UC patients was determined using the total index score [22].”
MethodRevisión del papel de los probióticos en la patología gastrointestinal del adulto
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Probiotics for inflammatory bowel disease: Is there sufficient evidence?
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“Two large studies [43,44] [50], VSL”
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“Moreover, probiotic bacteria have also been shown to reduce inflammation, improve gastrointestinal tract homeostasis (Tursi et al. 2010),”
BackgroundShen, H., Zhang, S., Zhao, W., Ren, S., Ke, X., Gu, Q., Tang, Z., Xie, J., Chen, S., Chen, Y., et al. (2021) · Biomedicine & Pharmacotherapy · doi:10.1016/j.biopha.2021.111580 · Cited by 42
Metadata
- Authors
- Tursi, A., Brandimarte, G., Papa, A., Giglio, A., Elisei, W., Giorgetti, G. M., Forti, G., Morini, S., Hassan, C., Pistoia, M. A., Modeo, M. E., Rodino', S., D'Amico, T., Sebkova, L., Sacca', N., Di Giulio, E., Luzza, F., Imeneo, M., Larussa, T., Di Rosa, S., Annese, V., Danese, S., & Gasbarrini, A.
- Affiliations
- Ospedale L. Bonomo (IT)
- Ospedale Cristo Re (IT)
- Agostino Gemelli University Polyclinic (IT)
- Azienda Ospedaliera Pugliese Ciaccio (IT)
- St. Eugenio Hospital (IT)
- Ospedale Santa Maria Goretti (IT)
- Azienda Universitaria Ospedaliera Consorziale - Policlinico Bari (IT)
- Azienda Ospedaliero-Universitaria "Renato Dulbecco" (IT)
- Casa Sollievo della Sofferenza (IT)
- Corresponding author
- Tursi, Antonio
- ORCID
- Venue
- American Journal of Gastroenterology
- Published
- 2010-10
- Volume
- 105
- Issue
- 10
- Pages
- 2218-2227
- ISSN
- 0002-9270 (ISSN-L)
- PMC
- PMC3180711
- OpenAlex
- W1998335236
- Cited by
- 489
- References
- 39
- Citations by year
- 2026: 10 · 2025: 22 · 2024: 35 · 2023: 30 · 2022: 29 · 2021: 28 · 2020: 46 · 2019: 31 · 2018: 39 · 2017: 38 · 2016: 28 · 2015: 29 · 2014: 38 · 2013: 27 · 2012: 28
- FWCI
- 15.30
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by-nc-nd
- www.springer.com/tdm (unspecified)
- Locations
- The American Journal of Gastroenterology (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- IRIS Research product catalog (Sapienza University of Rome) (submittedVersion)
- Archivio Istituzionale della Ricerca - Università Vita-Salute San Raffaele (submittedVersion)
- Archivio Istituzionale della Ricerca - Università degli Studi dell Aquila (submittedVersion)
- Topics
- Health Sciences › Medicine › Gastroenterology › Inflammatory Bowel Disease
- Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
- Keywords
- ulcerative colitis, VSL#3, probiotics, adjunctive therapy, relapsing disease, 5-aminosalicylic acid, immunosuppressants, disease activity, rectal bleeding, stool frequency, inflammatory bowel disease treatment, pouchitis, Crohn's disease, irritable bowel syndrome, irritable bowel syndrome with diarrhea
- MeSH terms
- Adult, Azathioprine, Bifidobacterium, Colitis, Ulcerative, Combined Modality Therapy, Double-Blind Method, Female, Humans, Lactobacillus, Male, Middle Aged, Recurrence, Remission Induction, Severity of Illness Index, Treatment Outcome, Patient Selection, Mesalamine, Probiotics, Streptococcus thermophilus
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