1.
Olendzki BC, Silverstein TD, Persuitte GM et al. Nutrition J 2014;13(5):1-7.
2.
Borowiec AM, Fedorak RN. Curr Gastro Rep 2007;9:393-400.
3.
Niedzielin K, Kordecki H, Birkenfeld B. Eur J Gastroenterol Hepatol 2001;13:1143-1147.
A randomized, double-blind, placebo-controlled trial of 40 patients who received TuZen 5x10
7 cfu/ml (n=20) or placebo (n=20) b.i.d. for 4 wks. All had a history of treatment with medication for IBS and at baseline were in the active stage of disease, with abdominal pain, altered stool frequency and consistency, and flatulence. A complete clinical examination was performed at baseline and wk 4, and patients assessed symptoms wkly. Pain relief was the primary outcome, with overall score the secondary measure. For all symptoms, 45% of TuZen patients showed complete resolution; 50% partial improvement; 5% no improvement. In the placebo group complete resolution was seen in 15% of patients and no improvement in 85% (p<0.0001).
4.
Ducrotté P, Sawant P, Jayanthi V. World J Gastroenterol 2012;18(30):4012-4018.
A multicentre, randomized, double-blind, placebo-controlled, parallel-design study of 214 patients receiving one capsule of TuZen or placebo daily for 4 wks. Frequency and intensity of abdominal pain, bloating and feeling of incomplete rectal emptying were assessed weekly on a visual analogue scale; stool frequency was calculated. At wk 4, investigators assessed TuZen efficacy as good or excellent in 82.8% of patients vs. 11.1% for placebo.
5.
Nobaek S, Johansson M-L, Molin G et al. Am J Gastroenterol 2000;95(5):1231-1238.
A randomized, double-blind, placebo-controlled trial of 60 patients receiving 5x10
7 cfu/ml of
L. plantarum or placebo for 4 wks. Patients recorded number of defecations, fecal consistency, presence/absence of abundant gas daily, and overall GI function weekly (defecation, pain, flatulence) on visual analog scales (VAS). 44% of TuZen patients reported reduced flatulence of at least 50% vs. 18% for placebo.
6.
Huynh HQ, deBruyn J, Guan L et al. Inflamm Bowl Dis 2009;15:760-768.
7.
Miele E, Pascarella F, Giannetti E et al. Am J Gastroenterol 2009;104:437-443.
A randomized, double-blind, placebo-controlled one-year study of 29 children with newly diagnosed UC who received either a weight-based dose of VSL#3 (range 450-1800 billion bacteria/day; n=14) or identical placebo (n=15) with concomitant steroid induction treatment (oral methylprednisolon 1 mg/kg/day, maximum 40 mg/day for 4 weeks, or oral mesalamine maintenance treatment (50 mg/kg/day). At 4 wks, patients in remission began tapering corticosteroids (by 25%/wk). On induction of remission, patients continued to receive mesalazine for 1 year or until relapse. Patient questionnaires recording stool frequency and consistency, hematochezia, abdominal pain, extraintestinal manifestations of disease and overall functioning were evaluated at 1 month, 2 months, 6 months and 1 year. Disease activity was measured by Lichtiger colitis activity index (LCAI) and physician’s global assessment. Remission=sustained drop in LCAI to < 2 after steroid therapy; response=decrease in LCAI > 3 points, final score > 3. Relapse=presence or worsening of symptoms with an LCAI increase > 3 points requiring corticosteroids, azathioprine/immunosuppressive agents or surgery. Remission was achieved in 92.8% of VSL#3 patients vs 36.4% in the placebo group; response was observed in 1 VSL#3 patient (7.2%) vs 11 placebo patients (63.6%), P<0.001.