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

NCT06637683 | Completed DMC

• 2 other identifiers: COLON 011015/GCN YDTB
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammatory Bowel Diseases

Keywords

Inflammatory Bowel Diseases (IBD); Bacillus spore; Crohn's disease; ulcerative colitis; adult

Outcome Measures

Primary Outcomes (1)

• Number of patients with IBD symptoms and score representing the severity of patients' IBD symptoms in control and experiment group

  Disease symptoms are assessed according to severity from 1-7 based on the 32-question IBDQ-32 questionnaire with 4 symptom assessment domains,including: Bowel Symptom (BS), Systemic Symptom (SS), Emotional Function (EF) and Social Function (SF). Each question is graded from 1 to 7 (1 is the worst situation and 7 is the best situation). The IBDQ total score is within the range from 32 to 224, higher score represented higher life quality.

  Day 0 and Day 7 and Day 30

Secondary Outcomes (2)

• Number of patients with positive changes in colon lesions before and after treatment

  Day 0 and Day 30

• Number of participants with abnormal laboratory blood test results

  Day 30

Study Arms (2)

Control group

PLACEBO COMPARATOR

The Control group receives routine treatment according to the hospital's standard internal medicine protocol, which includes: * Anti-inflammatory drugs: sulfasalazine (Azulfidine®), corticosteroids (Prednisone) * Immunosuppressants: azathioprine (Imuran®) and mercaptopurine (Purinethol®) * Antibiotics: metronidazole (Metrogyl®) * Other medications: anti-diarrheal drugs, laxatives, and other pain relievers (as prescribed by a doctor). All concurrent medications will be documented accordingly.

Other: Routine treatment

Test group

EXPERIMENTAL

The Experimental group receives the routine treatment and uses distilled water plus B. subtilis and B. clausii at 3 billion CFU/5 mL (LiveSpo COLON) The standard internal medicine treatment protocol of the hospital includes: * Anti-inflammatory drugs: sulfasalazine (Azulfidine®), corticosteroids (Prednisone) * Immunosuppressants: azathioprine (Imuran®) and mercaptopurine (Purinethol®) * Antibiotics: metronidazole (Metrogyl®) * Other medications: anti-diarrheal drugs, laxatives, and other pain relievers (as prescribed by a doctor). All concurrent medications will be documented accordingly.

Combination Product: LiveSpo COLON

Interventions

Routine treatment OTHER

The standard internal medicine treatment protocol of the hospital

Control group

LiveSpo COLON COMBINATION_PRODUCT

LiveSpo® COLON has a registration number: 10401/2019/ĐKSP issued by the Food Safety Department of the Ministry of Health in Vietnam

Test group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 years and older.
• Diagnosed with IBD based on the hospital's routine diagnostic process, which includes: (i) Positive stool test for bacteria, parasites, or fungi; (ii) Colonoscopy results showing ulcerative lesions with biopsy samples taken for histopathology; (iii) Presence of persistent gastrointestinal symptoms such as abdominal pain, stool disorders (diarrhea or constipation with mucus and blood), fatigue, and weight loss.
• Patients who have voluntarily signed the consent form to participate in the study.

You may not qualify if:

• Patients who did not participate in any other clinical trial during 3 months before this study or use any probiotic product as similar as the experimental product
• Patients were indicated for surgery to treat ulcerative colitis.

Sponsors & Collaborators

• Thai Binh University of Medicine and Pharmacy: collaborator
• Anabio R&D: lead
• Vietstar Biomedical Research: collaborator

Study Sites (1)

Thai Binh University of Medicine and Pharmacy

Thái Bình, 61000, Vietnam

Location

Related Publications (10)

• 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.

  PMID: 27825987 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.

  PMID: 19091823 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.

  PMID: 30353462 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.

  PMID: 31952938 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.

  PMID: 18438406 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.

  PMID: 19174792 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.

  PMID: 32377552 BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Nguyen T Binh, Assoc.Prof.

  Thai Binh University of Medicine and Pharmacy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: This is a single-blind study, while both patients and care providers know clearly which product is being tested, the assessor in the study is a blind assessor to ensure objectivity in the assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A randomized, single-blind, controlled clinical trial

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 15, 2024
• Study Start: November 15, 2019
• Primary Completion: March 15, 2020
• Study Completion: June 20, 2020
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a study protocol, informed consent form (ICF), clinical study report (CSR). For more information or to submit a request, please contact clinicaltrial.probiotics@gmail.com

Locations

VN (1)