The Probiotic Preparation, VSL#3 Induces Remission in Patients With Mild-to-Moderately Active Ulcerative Colitis
Abstract
Background & aims Probiotics can maintain ulcerative colitis (UC) in remission effectively, but little is known of their ability to induce remission. We conducted a multicenter, randomized, double-blind, placebo-controlled trial of a high-potency probiotic, VSL#3, for the treatment of mild-to-moderately active UC.Methods Adult patients with mild-to-moderate UC were assigned randomly to groups that were given 3.6 x 10(12) CFU VSL#3 (n = 77) or placebo (n = 70), twice daily for 12 weeks. The primary end point was a 50% decrease in the Ulcerative Colitis Disease Activity Index (UCDAI) at 6 weeks. The secondary end points included remission by 12 weeks and reduction in total individual UCDAI parameters from baseline at 12 weeks. Intention-to-treat analysis was performed.Results At week 6, the percentage of patients with an improvement in UCDAI score that was greater than 50% was significantly higher in the group given VSL#3 (25; 32.5%) than the group given placebo (7; 10%) (P = .001). At week 12, there were 33 patients given VSL#3 (42.9%) who achieved remission, compared with 11 patients given placebo (15.7%) (P < .001). Furthermore, significantly more patients given VSL#3 (40; 51.9%) achieved a decrease in their UCDAI that was greater than 3 points, compared with those given placebo (13; 18.6%) (P < .001). The VSL#3 group had significantly greater decreases in UCDAI scores and individual symptoms at weeks 6 and 12, compared with the placebo group.Conclusions VSL#3 is safe and effective in achieving clinical responses and remissions in patients with mild-to-moderately active UC.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
The probiotic mixture VSL#3 reduces ulcerative colitis symptoms in adults and induces remission in children.
“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 [144]
Cites
AFRC, R. F. (1989) · Journal of Applied Bacteriology · doi:10.1111/j.1365-2672.1989.tb05105.x · Cited by 4,831 · see citing works
Inflammatory bowel disease: clinical aspects and established and evolving therapies
Baumgart, D. C., & Sandborn, W. J. (2007) · The Lancet · doi:10.1016/s0140-6736(07)60751-x · Cited by 1,921 · see citing works
Gionchetti, P., Rizzello, F., Venturi, A., Brigidi, P., Matteuzzi, D., Bazzocchi, G., Poggioli, G., Miglioli, M., & Campieri, M. (2000) · Gastroenterology · doi:10.1053/gast.2000.9370 · Cited by 1,485 · see citing works
Sellon, R. K., Tonkonogy, S., Schultz, M., Dieleman, L. A., Grenther, W., Balish, E., Rennick, D. M., & Sartor, R. B. (1998) · Infection and Immunity · doi:10.1128/iai.66.11.5224-5231.1998 · Cited by 1,483 · see citing works
Mucosal flora in inflammatory bowel disease
Swidsinski, A. V., Ladhoff, A., Pernthaler, A., Swidsinski, S., Loening-Baucke, V. A., Ortner, M., Weber, J., Hoffmann, U., Schreiber, S., Dietel, M., et al. (2002) · Gastroenterology · doi:10.1053/gast.2002.30294 · Cited by 1,344 · see citing works
Kruis, W., Frič, P., Pokrotnieks, J., Lukáš, M., Fixa, B., Kaščák, M., Kamm, M. A., Weismueller, J., Beglinger, C., Stolte, M., et al. (2004) · Gut · doi:10.1136/gut.2003.037747 · Cited by 1,285 · see citing works
Prophylaxis of pouchitis onset with probiotic therapy: a double-blind, placebo-controlled trial
Gionchetti, P., Rizzello, F., Helwig, U., Venturi, A., Lammers, K. M., Brigidi, P., Vitali, B., Poggioli, G., Miglioli, M., & Campieri, M. (2003) · Gastroenterology · doi:10.1016/s0016-5085(03)00171-9 · Cited by 1,147 · see citing works
Rembacken, B., Snelling, A. M., Hawkey, P. M., Chalmers, D. M., & Axon, A. (1999) · The Lancet · doi:10.1016/s0140-6736(98)06343-0 · Cited by 1,100 · see citing works
Probiotic bacteria enhance murine and human intestinal epithelial barrier function
Madsen, K., Cornish, A. S., Soper, P., McKaigney, C. J., Jijon, H. B., Yachimec, C., Doyle, J. S. G., Jewell, L. D., & Simone, C. D. (2001) · Gastroenterology · doi:10.1053/gast.2001.27224 · Cited by 1,096 · see citing works
Sartor, R. B. (2004) · Gastroenterology · doi:10.1053/j.gastro.2004.03.024 · Cited by 1,053 · see citing works
Kruis, W., SCHÜTZ, E., Fric, P., Fixa, B., Judmaier, G., & Stolte, M. (1997) · Alimentary Pharmacology & Therapeutics · doi:10.1046/j.1365-2036.1997.00225.x · Cited by 774 · see citing works
Furrie, E., Macfarlane, S., Kennedy, A., Cummings, J. H., Walsh, S. V., O’Neil, D. A., & Macfarlane, G. T. (2005) · Gut · doi:10.1136/gut.2004.044834 · Cited by 766 · see citing works
Lactobacillus species prevents colitis in interleukin 10 gene–deficient mice
Madsen, K. L., Doyle, J. S. G., Jewell, L. D., Tavernini, M. M., & Fedorak, R. N. (1999) · Gastroenterology · doi:10.1016/s0016-5085(99)70013-2 · Cited by 761 · see citing works
VSL#3 Probiotic-Mixture Induces Remission in Patients with Active Ulcerative Colitis
Bibiloni, R., Fedorak, R. N., Tannock, G. W., Madsen, K. L., Gionchetti, P., Campieri, M., Simone, C. D., & Sartor, R. B. (2005) · The American Journal of Gastroenterology · doi:10.1111/j.1572-0241.2005.41794.x · Cited by 743 · see citing works
Modulation of human dendritic cell phenotype and function by probiotic bacteria
Hart, A. L., Lammers, K., Brigidi, P., Vitali, B., Rizzello, F., Gionchetti, P., Campieri, M., Kamm, M. A., Knight, S. C., & Stagg, A. J. (2004) · Gut · doi:10.1136/gut.2003.037325 · Cited by 555 · see citing works
Safety of Probiotics That Contain Lactobacilli or Bifidobacteria
Borriello, S. P., Hammes, W. P., Holzapfel, W. H., Marteau, P. R., Schrezenmeir, J., Vaara, M., & Valtonen, V. (2003) · Clinical Infectious Diseases · doi:10.1086/368080 · Cited by 550 · see citing works
Miele, E., Pascarella, F., Giannetti, E., Quaglietta, L., Baldassano, R. N., & Staiano, A. (2009) · The American Journal of Gastroenterology · doi:10.1038/ajg.2008.118 · Cited by 517 · see citing works
Functional modulation of enterocytes by gram-positive and gram-negative microorganisms
Otte, J., & Podolsky, D. K. (2004) · American Journal of Physiology-Gastrointestinal and Liver Physiology · doi:10.1152/ajpgi.00341.2003 · Cited by 403 · see citing works
Kato, K., Mizuno, S., Umesaki, Y., Ishii, Y., Sugitani, M., Imaoka, A., Otsuka, M., Hasunuma, O., Kurihara, R., Iwasaki, A., et al. (2004) · Alimentary Pharmacology & Therapeutics · doi:10.1111/j.1365-2036.2004.02268.x · Cited by 397 · see citing works
Probiotic lactobacilli and VSL#3 induce enterocyte β‐defensin 2
Schlee, M., Harder, J., Köten, B., Stange, E., Wehkamp, J., & Fellermann, K. (2008) · Clinical and Experimental Immunology · doi:10.1111/j.1365-2249.2007.03587.x · Cited by 393 · see citing works
A pilot trial of Saccharomyces boulardii in ulcerative colitis
Guslandi, M., Giollo, P., & Testoni, P. A. (2003) · European Journal of Gastroenterology & Hepatology · doi:10.1097/00042737-200306000-00017 · Cited by 383 · see citing works
Immunostimulatory DNA ameliorates experimental and spontaneous murine colitis
Rachmilewitz, D., Karmeli, F., Takabayashi, K., Hayashi, T., Leider–Trejo, L., Lee, J., Leoni, L. M., & Raz, E. (2002) · Gastroenterology · doi:10.1053/gast.2002.32994 · Cited by 380 · see citing works
Randomized Controlled Trial of the Effect of Bifidobacteria-Fermented Milk on Ulcerative Colitis
Ishikawa, H., Akedo, I., Umesaki, Y., Tanaka, R., Imaoka, A., & Otani, T. (2003) · Journal of the American College of Nutrition · doi:10.1080/07315724.2003.10719276 · Cited by 369 · see citing works
Petrof, E. O., Kojima, K., Ropeleski, M. J., Musch, M. W., Tao, Y., Simone, C. D., & Chang, E. B. (2004) · Gastroenterology · doi:10.1053/j.gastro.2004.09.001 · Cited by 330 · see citing works
Lammers, K. M., Brigidi, P., Vitali, B., Gionchetti, P., Rizzello, F., Caramelli, E., Matteuzzi, D., & Campieri, M. (2003) · FEMS Immunology & Medical Microbiology · doi:10.1016/s0928-8244(03)00144-5 · Cited by 282 · see citing works
Tursi, A., Brandimarte, G., Giorgetti, G. M., Forti, G., Modeo, M. E., & Gigliobianco, A. (2004) · PubMed · Cited by 241 · see citing works
Probiotics for induction of remission in ulcerative colitis
Mallon, P. T., McKay, D., Kirk, S. J., & Gardiner, K. R. (2007) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd005573.pub2 · Cited by 197 · see citing works
Huynh, H. Q., deBruyn, J. C. C., Guan, L. L., Díaz, H., Li, M., Girgis, S., Turner, J. M., Fedorak, R. N., & Madsen, K. L. (2008) · Inflammatory Bowel Diseases · doi:10.1002/ibd.20816 · Cited by 147 · see citing works
The mode of action of the aminosalicylates in inflammatory bowel disease
Greenfield, S., Punchard, N. A., TEARE, J. P., & Thompson, R. P. H. (1993) · Alimentary Pharmacology & Therapeutics · doi:10.1111/j.1365-2036.1993.tb00110.x · Cited by 145 · see citing works
Variable Response to Probiotics in Two Models of Experimental Colitis in Rats
Shibolet, O., Karmeli, F., Eliakim, R., Swennen, E., Brigidi, P., Gionchetti, P., Campieri, M., Morgenstern, S., & Rachmilewitz, D. (2002) · Inflammatory Bowel Diseases · doi:10.1097/00054725-200211000-00004 · Cited by 127 · see citing works
Chapman, T. M., Plosker, G. L., & Figgitt, D. P. (2006) · Drugs · doi:10.2165/00003495-200666100-00006 · Cited by 119 · see citing works
Enhanced anti-inflammatory effects of a nitric oxide–releasing derivative of mesalamine in rats
Wallace, J. L., Vergnolle, N., Muscará, M. N., Asfaha, S., Chapman, K., McKnight, W., Soldato, P. D., Morelli, A., & Fiorucci, S. (1999) · Gastroenterology · doi:10.1016/s0016-5085(99)70448-8 · Cited by 96 · see citing works
Intestinal microflora in human and experimental inflammatory bowel disease
Sartor, R. B. (2001) · Current Opinion in Gastroenterology · doi:10.1097/00001574-200107000-00005 · Cited by 75 · see citing works
Probiotics in the Treatment of Human Inflammatory Bowel Diseases
Fedorak, R. N., & Dieleman, L. A. (2008) · Journal of Clinical Gastroenterology · doi:10.1097/mcg.0b013e3181618ac7 · Cited by 28 · see citing works
Monitoring activity in ulcerative colitis
Rizzello, F., Gionchetti, P., Venturi, A., Amadini, C., Romagnoli, R., & Campieri, M. (2002) · Alimentary Pharmacology & Therapeutics · doi:10.1046/j.1365-2036.16.s4.1.x · Cited by 22 · see citing works
Flagged first, then by citations
Cited by
Sorted by citations
Parada Venegas, D., De la Fuente, M. K., Landskron, G., González, M. J., Quera, R., Dijkstra, G., Harmsen, H. J. M., Faber, K. N., & Hermoso, M. A. (2019) · Frontiers in Immunology · doi:10.3389/fimmu.2019.00277 · Cited by 3,820 · see citing works
Effects of probiotics, prebiotics, and synbiotics on human health
Markowiak, P., & Śliżewska, K. (2017) · Nutrients · doi:10.3390/nu9091021 · Cited by 2,401 · see citing works
Environmental triggers in IBD: a review of progress and evidence
Ananthakrishnan, A. N., Bernstein, C. N., Iliopoulos, D., Macpherson, A., Neurath, M. F., Ali, R. A. R., Vavricka, S. R., & Fiocchi, C. (2018) · Nature Reviews Gastroenterology & Hepatology · doi:10.1038/nrgastro.2017.136 · Cited by 948 · see citing works
The gut microbiota and inflammatory bowel disease
Matsuoka, K., & Kanai, T. (2015) · Seminars in Immunopathology · doi:10.1007/s00281-014-0454-4 · Cited by 804 · see citing works
Safety assessment of probiotics for human use
Sanders, M. E., Akkermans, L. M. A., Haller, D., Hammerman, C., Heimbach, J. T., Hörmannsperger, G., & Huys, G. (2010) · Gut Microbes · doi:10.4161/gmic.1.3.12127 · Cited by 816 · see citing works
Khan, I., Ullah, N., Zha, L., Bai, Y., Khan, A., Zhao, T., Che, T., & Zhang, C. (2019) · Pathogens · doi:10.3390/pathogens8030126 · Cited by 771 · see citing works
An update on the use and investigation of probiotics in health and disease
Sanders, M. E., Guarner, F., Guerrant, R., Holt, P. R., Quigley, E. M., Sartor, R. B., Sherman, P. M., & Mayer, E. A. (2013) · Gut · doi:10.1136/gutjnl-2012-302504 · Cited by 503 · see citing works
Microbial Translocation Across the GI Tract
Brenchley, J. M., & Douek, D. C. (2012) · Annual Review of Immunology · doi:10.1146/annurev-immunol-020711-075001 · Cited by 496 · see citing works
Bifidobacteria and Their Health-Promoting Effects
Hidalgo-Cantabrana, C., Delgado, S., Ruiz, L., Ruas-Madiedo, P., Sánchez, B., & Margolles, A. (2017) · Microbiology Spectrum · doi:10.1128/microbiolspec.bad-0010-2016 · Cited by 490 · see citing works
Tursi, A., Brandimarte, G., Papa, A., Giglio, A., Elisei, W., Giorgetti, G. M., Forti, G., Morini, S., Hassan, C., Pistoia, M. A., et al. (2010) · American Journal of Gastroenterology · doi:10.1038/ajg.2010.218 · Cited by 489 · see citing works
Systematic review with meta-analysis: The efficacy of probiotics in inflammatory bowel disease
Derwa, Y., Gracie, D. J., Hamlin, P. J., & Ford, A. C. (2017) · Alimentary Pharmacology & Therapeutics · doi:10.1111/apt.14203 · Cited by 393 · see citing works
Shen, J., Zuo, Z.-X., & Mao, A.-P. (2014) · Inflammatory Bowel Diseases · doi:10.1097/01.mib.0000437495.30052.be · Cited by 364 · see citing works
Interactions between Intestinal Microbiota and Host Immune Response in Inflammatory Bowel Disease
Zhang, M., Sun, K., Wu, Y., Yang, Y., Tso, P., & Wu, Z. (2017) · Frontiers in Immunology · doi:10.3389/fimmu.2017.00942 · Cited by 347 · see citing works
Ganji‐Arjenaki, M., & Rafieian‐Kopaei, M. (2018) · Journal of Cellular Physiology · doi:10.1002/jcp.25911 · Cited by 314 · see citing works
Jonkers, D., Penders, J., Masclee, A., & Pierik, M. (2012) · Drugs · doi:10.2165/11632710-000000000-00000 · Cited by 240 · see citing works
Update of probiotics in human world: A nonstop source of benefactions till the end of time
Zommiti, M., Feuilloley, M. G. J., & Connil, N. (2020) · Microorganisms · doi:10.3390/microorganisms8121907 · Cited by 225 · see citing works
Leveraging diet to engineer the gut microbiome
Wolter, M., Grant, E. T., Boudaud, M., Steimle, A., Pereira, G. V., Martens, E. C., & Desai, M. S. (2021) · Nature Reviews Gastroenterology & Hepatology · doi:10.1038/s41575-021-00512-7 · Cited by 211 · see citing works
Yılmaz, İ., Dolar, M. E., & Özpınar, H. (2019) · Turkish Journal of Gastroenterology · doi:10.5152/tjg.2018.18227 · Cited by 193 · see citing works
Zhang, X.-F., Guan, X.-X., Tang, Y.-J., Sun, J.-F., Wang, X.-K., Wang, W.-D., & Fan, J.-M. (2021) · European Journal of Nutrition · doi:10.1007/s00394-021-02503-5 · Cited by 193 · see citing works
The intestinal microbiota in inflammatory bowel disease
Becker, C., Neurath, M. F., & Wirtz, S. (2015) · ILAR Journal · doi:10.1093/ilar/ilv030 · Cited by 185 · see citing works
Miele, E., Shamir, R., Aloi, M., Assa, A., Braegger, C., Bronsky, J., de Ridder, L., Escher, J. C., Hojsak, I., Kolaček, S., et al. (2018) · Journal of Pediatric Gastroenterology and Nutrition · doi:10.1097/mpg.0000000000001896 · Cited by 191 · see citing works
Probiotics, fibre and herbal medicinal products for functional and inflammatory bowel disorders
Currò, D., Ianiro, G., Pecere, S., Bibbò, S., & Cammarota, G. (2017) · British Journal of Pharmacology · doi:10.1111/bph.13632 · Cited by 160 · see citing works
Probiotic mixture VSL# 3: An overview of basic and clinical studies in chronic diseases
Cheng, F.-S., Pan, D., Chang, B., Jiang, M., & Sang, L.-X. (2020) · World Journal of Clinical Cases · doi:10.12998/wjcc.v8.i8.1361 · Cited by 147 · see citing works
Efficacy of Bifidobacterium breve fermented milk in maintaining remission of ulcerative colitis
Matsuoka, K., Uemura, Y., Kanai, T., Kunisaki, R., Suzuki, Y., Yokoyama, K., Yoshimura, N., & Hibi, T. (2018) · Digestive Diseases and Sciences · doi:10.1007/s10620-018-4946-2 · Cited by 128 · see citing works
Arthur, J. C., Gharaibeh, R. Z., Uronis, J. M., Perez-Chanona, E., Sha, W., Tomkovich, S., Mühlbauer, M., Fodor, A. A., & Jobin, C. (2013) · Scientific Reports · doi:10.1038/srep02868 · Cited by 118 · see citing works
Corridoni, D., Pastorelli, L., Mattioli, B., Locovei, S., Ishikawa, D., Arseneau, K. O., Chieppa, M., Cominelli, F., & Pizarro, T. T. (2012) · PLoS ONE · doi:10.1371/journal.pone.0042067 · Cited by 118 · see citing works
Dore, M. P., Bibbò, S., Fresi, G., Bassotti, G., & Pes, G. M. (2019) · Nutrients · doi:10.3390/nu11122913 · Cited by 83 · see citing works
Estevinho, M. M., Yuan, Y., Rodríguez‐Lago, I., Sousa‐Pimenta, M., Dias, C. C., Barreiro‐de Acosta, M., Jairath, V., & Magro, F. (2024) · United European gastroenterology journal · doi:10.1002/ueg2.12636 · Cited by 74 · see citing works
“Four studies provided data on the induction of endoscopic remission (one 46 in CD and three 40,49,65 in UC).”
Darb Emamie, A., Rajabpour, M., Ghanavati, R., Asadolahi, P., Farzi, S., Sobouti, B., & Darbandi, A. (2021) · Journal of Applied Microbiology · doi:10.1111/jam.14907 · Cited by 57 · see citing works
Gut microbiota and inflammatory bowel disease: the role of antibiotics in disease management
Kerman, D. H., & Deshpande, A. R. (2014) · Postgraduate Medicine · doi:10.3810/pgm.2014.07.2779 · Cited by 47 · see citing works
- Authors
- Sood, A., Midha, V., Makharia, G. K., Ahuja, V., Singal, D., Goswami, P., & Tandon, R. K.
- Affiliations
- Dayanand Medical College & Hospital (IN)
- All India Institute of Medical Sciences (IN)
- Pushpawati Singhania Research Institute (IN)
- Corresponding author
- Tandon, Rakesh K.
- Venue
- Clinical Gastroenterology and Hepatology
- Publisher
- Elsevier BV
- Published
- 2009-11
- Volume
- 7
- Issue
- 11
- Pages
- 1202-1209.e1
- ISSN
- 1542-3565 (ISSN-L)
- OpenAlex
- W2150366828
- Cited by
- 513
- References
- 35
- Citations by year
- 2026: 16 · 2025: 22 · 2024: 30 · 2023: 26 · 2022: 28 · 2021: 27 · 2020: 36 · 2019: 33 · 2018: 37 · 2017: 43 · 2016: 27 · 2015: 28 · 2014: 49 · 2013: 22 · 2012: 39
- FWCI
- 17.06
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Clinical Gastroenterology and Hepatology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › 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
- VSL#3, probiotics, ulcerative colitis, remission induction, inflammatory bowel disease treatment
- MeSH terms
- Adult, Colitis, Ulcerative, Double-Blind Method, Female, Humans, Immunologic Factors, Male, Middle Aged, Placebos, Severity of Illness Index, Probiotics, Intention to Treat Analysis
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review