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.

Conditions

• Inflammatory Bowel Diseases

Interventions

COMBINATION_PRODUCT

LiveSpo COLON

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

OTHER

Routine treatment

The standard internal medicine treatment protocol of the hospital

Sponsors & Collaborators

• Vietstar Biomedical Research

  collaborator INDUSTRY

• Thai Binh University of Medicine and Pharmacy

  collaborator OTHER

• Anabio R&D

  lead INDUSTRY

Principal Investigators

• Nguyen T Binh, Assoc.Prof. · Thai Binh University of Medicine and Pharmacy

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-11-15

Primary Completion

2020-03-15

Completion

2020-06-20

Countries

• Vietnam

Study Locations