Multi-Strain and High-Concentration Bacillus Probiotic Spores (LiveSpo COLON) in the Supportive Treatment of Inflammatory Bowel Disease (IBD): A Blind, Randomized, and Controlled Trial

Inflammatory bowel disease (IBD) is a prevalent condition encompassing two major types: (1) Crohn disease (chronic enteritis characterized by symptoms such as abdominal pain, stool irregularities, fatigue, weight loss, and malnutrition) and (2) ulcerative colitis, often associated with bloody stools. In Vietnam, it is estimated that in 2018, about 4 million Vietnamese suffered from chronic colitis. IBD affects approximately 20% of the population, with 20% of these patients at risk of developing colon cancer. The pathogenesis of chronic IBD remains unclear. Recent studies have noted abnormalities in the gut microbiota in Crohn's disease, including an increase in pathogenic bacteria such as E. coli, Proteobacteria, and Actinobacteria, and a decrease in Firmicutes and Bacteroides.

The treatment of IBD is challenging and complex due to its progressive nature and recurring episodes. The current treatment goal for IBD is to address inflammation. Many medications help reduce inflammation, including anti-inflammatory drugs such as sulfasalazine, corticosteroids like prednisone, and immunosuppressants such as azathioprine and mercaptopurine. Metronidazole is an antibiotic that can also help eliminate bacteria in the intestines, particularly in cases of Crohn disease. Most people with chronic IBD will need to take at least one type of medication for an extended period to reduce current symptoms, prevent inflammation, and decrease the frequency of future episodes. However, some anti-inflammatory drugs or steroids can cause numerous adverse effects, such as nausea, increased risk of infections, osteoporosis, diabetes, and obesity. Additionally, the use of antibiotics can negatively impact the gut microbiota, especially with prolonged treatment and increased drug resistance. Patients with severe ulcerative colitis who do not respond to medical treatment may require surgery to remove part or all of the colon.

Probiotics are live microorganisms that can provide health benefits when consumed in adequate amounts, typically ranging from 1 to 10 billion per day, depending on the purpose of prevention or supportive treatment. The probiotic Lactobacillus plantarum L.1375 has been shown to be as effective as mesalamine, promoting the secretion of anti-inflammatory cytokines used in the treatment of Crohn's disease. However, oral probiotics containing Lactobacillus have shown lower efficacy due to their reduced resilience and survival in the acidic environment of the stomach compared to Bacillus strains. Several Bacillus species, such as B. subtilis and B. clausii, have the ability to form endospores, allowing them to withstand harsh environmental conditions like heat, acid, and bile. This means that Bacillus probiotics are more likely to survive in the harsh conditions of the gastrointestinal tract and reach the small intestines, where they can provide various health benefits. Bacillus probiotics have also demonstrated natural resistance to some antibiotics, making them a potentially more effective option for patients taking antibiotics or with a history of antibiotic use.

The objective of this study was to evaluate the safety and 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.

A randomized, blind, controlled clinical trial was conducted. Participants provided various information, including their names, ages, and antibiotic/anti-inflammatory history. After obtaining informed consent, 60 eligible patients were randomly assigned to two groups (n = 30/group) using permuted block randomization with R.3.2 software. The Control group received conventional treatment, while the Experimental group (Colon group) received LiveSpo® Colon (3 billion CFU/5 mL) at a dose of 3 ampoules/day-one ampoule in the morning, noon, and evening-in addition to the conventional treatment. All patients were monitored for 30 days, after which they continued under hospital care following standard protocol. Clinical and subclinical evaluations were performed on Days 7 and 30.