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Clinical Evidence Supporting VSL#3 for the Treatment of Ulcerative Colitis and Pouchitis

By Edited Sep 6, 2016 0 0

ulcerative colitis toilet

VSL#3 is a probiotic mix that contains eight unique strains of bacteria. Formulated by scientists in Italy, it is now highly respected by many medical organizations as a treatment for both Ulcerative Colitis (UC) and pouchitis[1]. VSL#3 is so potent that it is not classified as a simple supplement. This is due to the high number of bacteria that most doses contain[1]. Instead, according to the Federal Drug Administration, it is classified as a medical food. Medical foods, which are generally available without a prescription, should still be taken under the supervision of a physician.

VSL#3 works by supporting the defense and function of the intestinal tract. Your intestines are the home for trillions of bacteria. Science is now discovering that some species of bacteria are better for you than others. Diversity and an optimal composition of bacterial species appear to be extremely important for optimal health. VSL#3 helps by supporting populations of good bacteria of the gut[2]. This is crucial for diseases like UC and pouchitis, which are suspected to be the result of a dysfunctional immune response coupled with changes in intestinal flora.

Ulcerative Colitis Treatment

UC is a form of inflammatory bowel disease. It is characterized by chronic inflammation in the large intestine, which leads to bloody diarrhea, cramping and a huge loss of life quality. The disease is known to wax and wane. During periods of reduced or no inflammation, it is considered to be in “remission.” When inflammation suddenly rears its ugly head, it’s called a “flare.” Therapy is aimed to extend remission periods for as a long as possible. Current treatments consist of anti-inflammatory and immunosuppressive drugs. Sometimes, surgery is required to remove the inflamed colon.

A more natural alternative to controlling UC is the goal of many researchers. In 1999, the first pivotal study was performed using the probiotic mixture, VSL#3, on UC patients to see if it could help them remain in remission. Twenty ulcerative colitis patients were treated for a year. Fifteen patients remained in remission, and there were no significant side effects except for mild bloating at the beginning of the study[3]. Five years later, another study discovered that combining VSL#3 with balsalazide, an anti-inflammatory drug, was more effective at inducing remission than balsalazide alone[4].

In 2005, they tested the bacterial mixture by itself in a larger study. Thirty-two patients were given the beneficial bacteria, and disease activity was measured before and after treatment. More than 75% of the patients responded positively[5]. This study was followed up later with a larger, placebo-controlled study that confirmed the findings. After a 12-week treatment protocol, 42.9% in the treatment group had obtained remissions, while only 15.7% were better in the placebo group[6].

Similar studies performed in pediatric UC patients also showed similar results. VSL#3 could both maintain and induce remissions[7][8].

Pouchitis Treatment

Pouchitis is actually a disease that appears after surgery in patients with UC. It is an inflammation that occurs after an ileo-anal pouch surgery. During this surgery, the colon is removed, and a small internal bag is formed from the small intestine. This bag, or ileal pouch, functions as a kind of colon. This form of surgery is usually performed when UC becomes too severe to control. In unlucky individuals, the ileal pouch becomes inflamed, and they become pouchitis patients. Treatment consists of hefty doses of antibiotics[9], which is why it is so necessary that other therapies be found.  

Studies on the ability of VSL#3 to improve pouchitis first appeared in 2000 in the highly respected journal, Gastroenterology. A double-blind, placebo-controlled trial was performed to see if VSL#3 could maintain the remission of chronic pouchitis patients for nine months. The results were fairly spectacular. Fifteen percent of the patients treated with the probiotics relapsed compared to 100% of the patients in the placebo group[10]. A larger study was performed four years later. It found that remission could be maintained for one year in 85% of the treated patients as opposed to 6% with placebo[11].

As VSL#3 was so effective at maintaining remission, further studies were organized to see if the probiotics could prevent pouchitis from even occurring. Groups of twenty patients were tested with either bacteria or a placebo. Only 10% of those treated with the probiotics developed pouchitis compared to 40% in the placebo group[12]. Additional studies also showed that VSL#3 could even induce remission. For this trial, patients with active mild pouchitis were chosen, and probiotics were given for four weeks. Although, no placebo group was tested, the results were extremely promising. Of those treated with the probiotic mixture, 69% made it into remission[13].

Given the potency of VSL#3 for UC and pouchitis, one wonders where else it could be applied. Other studies have shown that it can be beneficial for irritable bowel syndrome[14] and even liver disease[15]. It will be exciting to see what future studies will say about its effectiveness in other conditions.



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  1. "Discover the Difference - VSL#3." VSL#3 - The Living Shield. 2/07/2013 <Web >
  2. Kühbacher T, Ott SJ, Helwig U, Mimura T, Rizzello F, Kleessen B, Gionchetti P, Blaut M, Campieri M, Fölsch UR, Kamm MA, Schreiber S. "Bacterial and fungal microbiota in relation to probiotic therapy (VSL#3) in pouchitis.." Gut. 55 (2006): 833-841.
  3. Venturi A, Gionchetti P, Rizzello F, Johansson R, Zucconi E, Brigidi P, Matteuzzi D, Campieri M. "Impact on the composition of the faecal flora by a new probiotic preparation: preliminary data on maintenance treatment of patients with ulcerative colitis. ." Aliment Pharmacol Ther. . 13 (1999): 1103-1108.
  4. Tursi A, Brandimarte G, Giorgetti GM, Forti G, Modeo ME, Gigliobianco A. "Low-dose balsalazide plus a high-potency probiotic preparation is more effective than balsalazide alone or mesalazine in the treatment of acute mild-to-moderate ulcerative colitis.." Med Sci Monit.. 10 (2004): PI126-131.
  5. Bibiloni R, Fedorak RN, Tannock GW, Madsen KL, Gionchetti P, Campieri M, De Simone C, Sartor RB. "VSL#3 probiotic-mixture induces remission in patients with active ulcerative colitis. ." Am J Gastroenterol. . 100 (2005): 1539-1546.
  6. Sood A, Midha V, Makharia GK, Ahuja V, Singal D, Goswami P, Tandon RK. "The probiotic preparation, VSL#3 induces remission in patients with mild-to-moderately active ulcerative colitis.." Clin Gastroenterol Hepatol.. 7 (2009): 1202-1209.
  7. Huynh HQ, deBruyn J, Guan L, Diaz H, Li M, Girgis S, Turner J, Fedorak R, Madsen K. "Probiotic preparation VSL#3 induces remission in children with mild to moderate acute ulcerative colitis: a pilot study.." Inflamm Bowel Dis.. 15 (2009): 760-768.
  8. Miele E, Pascarella F, Giannetti E, Quaglietta L, Baldassano RN, Staiano A. "Effect of a probiotic preparation (VSL#3) on induction and maintenance of remission in children with ulcerative colitis. ." Am J Gastroenterol.. 104 (2009): 437-443.
  9. "Pouchitis." Wikipedia. 2/07/2013 <Web >
  10. Gionchetti P, Rizzello F, Venturi A, Brigidi P, Matteuzzi D, Bazzocchi G, Poggioli G, Miglioli M, Campieri M. "Oral bacteriotherapy as maintenance treatment in patients with chronic pouchitis: a double-blind, placebo-controlled trial. ." Gastroenterology. 119 (2000): 305-309.
  11. Mimura T, Rizzello F, Helwig U, Poggioli G, Schreiber S, Talbot IC, Nicholls RJ, Gionchetti P, Campieri M, Kamm MA. "Once daily high dose probiotic therapy (VSL#3) for maintaining remission in recurrent or refractory pouchitis.." Gut. 53 (2004): 108-114.
  12. Gionchetti P, Rizzello F, Helwig U, Venturi A, Lammers KM, Brigidi P, Vitali B, Poggioli G, Miglioli M, Campieri M. "Prophylaxis of pouchitis onset with probiotic therapy: a double-blind, placebo-controlled trial. ." Gastroenterology. 124 (2003): 1202-1209.
  13. Gionchetti P, Rizzello F, Morselli C, Poggioli G, Tambasco R, Calabrese C, Brigidi P, Vitali B, Straforini G, Campieri M. "High-dose probiotics for the treatment of active pouchitis.." Dis Colon Rectum. . 50 (2007): 2075-2082.
  14. Kim HJ, Vazquez Roque MI, Camilleri M, Stephens D, Burton DD, Baxter K, Thomforde G, Zinsmeister AR. "A randomized controlled trial of a probiotic combination VSL# 3 and placebo in irritable bowel syndrome with bloating. ." Neurogastroenterol Motil.. 17 (2005): 687-696.
  15. Loguercio C, Federico A, Tuccillo C, Terracciano F, D'Auria MV, De Simone C, Del Vecchio Blanco C. "Beneficial effects of a probiotic VSL#3 on parameters of liver dysfunction in chronic liver diseases. ." J Clin Gastroenterol.. 39 (2005): 540-543.

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