References and study details
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 5x107 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 5x107 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.
8. Shen J, Zuo Z-X, Mao A-P. Inflamm Bowel Dis 2014;20(1):21-35.
A meta-analysis of 23 randomized controlled trials with a total of 1763 participants. Remission rates were significantly higher in patients with active UC receiving VSL#3 than placebo (P<0.0001); VSL#3 significantly increased remission rates compared with controls in patients with active UC (P=0.004); VSL#3 significantly reduced relapse rates to maintain remission in patients with pouchitis (P<0.00001).
9. Tursi A, Brandimarte G, Papa A et al. Am J Gastroenterol 2010;105:2218-2227.
A randomized, double-blind, placebo-controlled trial of VSL#3 as an adjunct to standard pharmaceutical treatment in 144 patients with relapsing mild-to-moderate ulcerative colitis (symptomatic recurrence after at least 6 months of remission with a new increase in ulcerative colitis disease activity index (UCDAI) of 3-8 points; evaluation included stool frequency, rectal bleeding, mucosal appearance and physician’s rating of disease activity). Of those completing the 8-wk study, 65 patients received VSL#3 3,600 billion cfu/day; 66 received placebo. At wk 8 63.1% of VSL#3 patients achieved an improvement in their UCDAI score > 50% vs 40.8% for placebo, P=0.010. Similar results were seen in secondary endpoints.
10. Szajewska H, Gyrczuk E, Horvath A. J Pediatr 2012;1-6.
A randomized, double-blind, placebo-controlled trial of 80 breastfed infants with colic, receiving BioGaia 108 cfus, n=40 or placebo, n=40 in 5 drops o.d. for 21 days. Primary outcomes were treatment success (% patients achieving a reduction in daily average crying time > 50%, and minutes/day crying at 7, 14, 21 and 28 days.) The response to BioGaia was significantly higher at days 7, 14, 21 and 28. Secondary outcomes were persistence of colic after intervention, parents’ perceptions of colic severity, and parental/family quality of life, which improved with BioGaia vs. placebo.
11. Savino F, Cordisco L, Tarasco V et al. Pediatrics 2010;e526-e533.
A randomized, double-blind, placebo-controlled trial of 50 infants with colic. Infants received 5 drops/day (BioGaia 108 cfu, n=25 study completers; placebo n=21 completers). Primary outcome was reduction of average crying time to < 3 hrs/day; secondary outcome was number of responders on days 7, 14, and 21. At day 21 BioGaia infants cried (median) 35 mins/day vs 90 mins/day placebo, P=0.022. Response (50% reduction in daily average crying time from baseline) was day 7: BioGaia 80% vs. placebo 38%; Day 14 BioGaia 96% vs. placebo 62%: Day 21 BioGaia 96% vs. placebo 71%. Fecal samples showed a significantly greater reduction of E. coli and increase in Lactobacilli in the BioGaia group vs. placebo.
12. Romano C, Ferrau V, Cavataio F et al. J Paed Child Health 2010;1-4.
A multi-centre, randomized, double-blind placebo-controlled trial of 60 children (6-16 yrs) receiving BioGaia 108 cfu b.i.d. (n=32) or placebo (n=28) for 4 wks followed by 4 wks without supplementation. Patients recorded frequency and intensity of pain. BioGaia children had significantly lower pain intensity at 4 and 8 wks vs. placebo.
The World Health Organization defines a clinical trial as “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.”
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