Efficacy of LiveSpo COLON as a Supportive Treatment for Inflammatory Bowel Disease (IBD)

Summary

Inflammatory bowel disease (IBD) is a prevalent condition, comprising two major types: (1) Crohn disease (chronic enteritis characterized by abdominal pain, stool irregularities, fatigue, weight loss, and malnutrition) and (2) ulcerative colitis, often presenting with bloody stools. In Vietnam, approximately 20% of the population was affected by IBD, with 20% of these patients being at risk of developing colon cancer. The primary goal of treatment for IBD is to address inflammation. Various medications were found to be effective in reducing inflammation, including anti-inflammatory and antibiotic drugs. However, the use of antibiotics had a negative impact on the gut microbiota, particularly with prolonged use and increased drug resistance. In response, the supplementation of probiotics was extensively researched and applied in the prevention and treatment of ulcerative colitis and other gastrointestinal disorders over the past decade. Oral probiotics containing Lactobacillus demonstrated lower efficacy due to reduced resilience and survival in the acidic stomach environment compared to Bacillus strains. Research suggested that supplementing with high-dose, multi-strain Bacillus probiotics could be a promising approach as supportive therapy for patients with chronic inflammatory bowel disease. The study aimed to evaluate the effectiveness of the oral probiotic LiveSpo COLON, containing 3 billion CFU/5 mL of B. subtilis and B. clausii, as a supportive treatment for patients with chronic IBD. Study Population: The sample size consisted of 60 patients diagnosed with ulcerative colitis at the Thai Binh University of Medicine and Pharmacy. Study Sites: The study was conducted at the Thai Binh University of Medicine and Pharmacy, Thai Binh, Vietnam. Description of Study Intervention: A total of 60 eligible patients were randomly divided into two groups (n = 30/group). Patients in the Control group received the conventional treatment regimen at the hospital, while those in the Experimental group (Colon group) were administered LiveSpo® Colon (3 billion CFU/5 mL) at a dose of 3 ampoules/day-one ampoule in the morning, noon, and evening-in combination with the conventional treatment regimen. All patients were monitored for 30 days, after which they continued to be observed following the protocol of the hospital. Study Duration: 5 months.

Timeline

Start

2019-11-15

Primary completion

2020-03-15

Completion

2020-06-20

Publications

• Background Lefevre M, Racedo SM, Denayrolles M, Ripert G, Desfougeres T, Lobach AR, Simon R, Pelerin F, Justen P, Urdaci MC. Safety assessment of Bacillus subtilis CU1 for use as a probiotic in humans. Regul Toxicol Pharmacol. 2017 Feb;83:54-65. doi: 10.1016/j.yrtph.2016.11.010. Epub 2016 Nov 5.
• Background Moayyedi P, Ford AC, Talley NJ, Cremonini F, Foxx-Orenstein AE, Brandt LJ, Quigley EM. The efficacy of probiotics in the treatment of irritable bowel syndrome: a systematic review. Gut. 2010 Mar;59(3):325-32. doi: 10.1136/gut.2008.167270. Epub 2008 Dec 17.
• Background Lee ES, Song EJ, Nam YD, Lee SY. Probiotics in human health and disease: from nutribiotics to pharmabiotics. J Microbiol. 2018 Nov;56(11):773-782. doi: 10.1007/s12275-018-8293-y. Epub 2018 Oct 24.
• Background Horosheva T V, Vodyanoy V, Sorokulova I. Efficacy of Bacillus probiotics in prevention of antibiotic-associated diarrhoea: a randomized double-blind, placebo-controlled clinical trial. JMM Case Reports. 2014;1(3):e004036
• Background Ismaeil H, Abdo W, Amer S, et al.Ameliorative Effect of Heat-Killed Lactobacillus plantarum L. 137 and/or Aloe vera against Colitis in Mice. Processes. 2020;8(2):225.
• Background Sadrin S, Sennoune S, Gout B, Marque S, Moreau J, Zinoune K, Grillasca JP, Pons O, Maixent JM. A 2-strain mixture of Lactobacillus acidophilus in the treatment of irritable bowel syndrome: A placebo-controlled randomized clinical trial. Dig Liver Dis. 2020 May;52(5):534-540. doi: 10.1016/j.dld.2019.12.009. Epub 2020 Jan 15.
• Background Horosheva TV, Vodyanoy V, & Sorokulova I. Efficacy of Bacillus probiotics in prevention of antibiotic-associated diarrhoea: a randomized, double-blind, placebo-controlled clinical trial. JMM Case Reports. 2014; 1(3), e004036.
• Background Fisher SA, Tremelling M, Anderson CA, Gwilliam R, Bumpstead S, Prescott NJ, Nimmo ER, Massey D, Berzuini C, Johnson C, Barrett JC, Cummings FR, Drummond H, Lees CW, Onnie CM, Hanson CE, Blaszczyk K, Inouye M, Ewels P, Ravindrarajah R, Keniry A, Hunt S, Carter M, Watkins N, Ouwehand W, Lewis CM, Cardon L; Wellcome Trust Case Control Consortium; Lobo A, Forbes A, Sanderson J, Jewell DP, Mansfield JC, Deloukas P, Mathew CG, Parkes M, Satsangi J. Genetic determinants of ulcerative colitis include the ECM1 locus and five loci implicated in Crohn's disease. Nat Genet. 2008 Jun;40(6):710-2. doi: 10.1038/ng.145. Epub 2008 Apr 27.
• Background 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. 2009 Feb;104(2):437-43. doi: 10.1038/ajg.2008.118. Epub 2009 Jan 20.
• Background Yarlas A, Maher S, Bayliss M, Lovley A, Cappelleri JC, Bushmakin AG, DiBonaventura MD. The Inflammatory Bowel Disease Questionnaire in Randomized Controlled Trials of Treatment for Ulcerative Colitis: Systematic Review and Meta-Analysis. J Patient Cent Res Rev. 2020 Apr 27;7(2):189-205. doi: 10.17294/2330-0698.1722. eCollection 2020 Spring.

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