NEW YORK (Reuters Health) – Patients with relapsing mild-to-moderate ulcerative colitis (UC) on immunosuppressive therapy may benefit from the addition of a high-potency probiotic mixture (VSL#3; VSL Pharmaceuticals Inc., Towson, Maryland), results of a randomized trial suggest.

Probiotic supplementation with VSL#3 “improves the clinical picture in patients suffering from UC and may avoid a new course of steroids,” lead author Dr. Antonio Tursi of “Lorenzo Bonomo” Hospital in Andria, Italy told Reuters Health by e-mail.

In the June 1 advanced online issue of the American Journal of Gastroenterology, Dr. Tursi and colleagues note that patients with UC may relapse despite treatment with anti-inflammatory drugs such as mesalazine, corticosteroids, immunosuppressants or biologics.

Modulation of the gut flora with probiotics has been suggested as an approach to manage UC, and VSL#3 has been shown to be effective for pouchitis.

Therefore, Dr. Tursi’s team enrolled 144 patients with relapsing UC who were already on stable doses of mesalazine and/or immunosuppressants. They randomly assigned 71 patients to 8 weeks of VSL#3 (3,600 billion colony-forming units per day) and 73 to placebo. In all, 65 patients in the VSL#3 group and 66 in the placebo group completed the study.

VSL#3 was significantly superior to placebo in reducing the activity of mild-to-moderate UC, both in per-protocol and intention-to-treat analyses. At week 8, 63.1% of VSL#3-treated patients and 40.8% in the placebo group had at least 50% improvement in their UC disease activity index score — the primary endpoint (p values were 0.01 per protocol and 0.03 on intent to treat).

As a secondary end point, remission rates at 8 weeks were higher, although not significantly so, in the VSL#3 group vs the placebo group (47.7% vs 32.4%; p = 0.07 per protocol).

“None of the patients in the VSL#3 group experienced any worsening of symptoms during follow up, whereas five individuals in the placebo group showed a deterioration in their clinical status and had to be withdrawn from the study,” the researchers said.

There were no significant between-group differences in stool frequency, physician rating of disease activity, and average endoscopy scores, although patients who received VSL#3 had a significant reduction in rectal bleeding compared with those who received placebo.

Eight patients in the VSL#3 group (11.3%) and nine in the placebo group (12.3%) reported mild side effects. No one in either group had a major adverse event.

Dr. Tursi said: “Since high doses of probiotics seem to be able to improve relapsing UC in patients under treatment with immunosuppressors, further studies are needed to understand whether this approach may also avoid or delay the use of biologics in these patients.”

The study was sponsored by VSL Pharmaceuticals.

Am J Gastroenterol 2010.