Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06637683
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
Efficacy of LiveSpo COLON as a Supportive Treatment for Inflammatory Bowel Disease IBD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 CFU5 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 30group 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 CFU5 mL at a dose of 3 ampoulesday-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
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 CFU5 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 30group 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 CFU5 mL at a dose of 3 ampoulesday-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
Detailed Description:
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 Crohns 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 L1375 has been shown to be as effective as mesalamine promoting the secretion of anti-inflammatory cytokines used in the treatment of Crohns 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 CFU5 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 antibioticanti-inflammatory history After obtaining informed consent 60 eligible patients were randomly assigned to two groups n 30group using permuted block randomization with R32 software The Control group received conventional treatment while the Experimental group Colon group received LiveSpo Colon 3 billion CFU5 mL at a dose of 3 ampoulesday-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
Clinical Evaluation
- Interview Conducted via telephone or at the research facility using the IBDQ-32 questionnaire to assess health-related quality of life in patients with IBD ulcerative colitis and Crohns disease The questionnaire covered bowel symptoms BS systemic symptoms SS emotional function EF and social function SF with each question rated from 1 to 7 1 being worst 7 being best Total IBDQ scores ranged from 32 to 224 assessed on Days 0 7 and 30
Sub-clinical Evaluation
Blood Tests 13 hematological indices and 7 biochemical indices were evaluated on Day 30
Colonoscopy Changes before and after treatment were assessed to evaluate lesion characteristics on colonoscopy including redness bleeding swelling and ulcers on Days 7 and 30
Data collection and statistical analysis involved compiling medical records and organizing patient information into a dataset The safety and efficacy of LiveSpo COLON were evaluated by comparing the Control and Colon groups based on changes in biochemical and hematological indicators improvement in IBD symptoms BS SS EF SF and total scores and improvements in colon ulcers redness inflammation bleeding swelling and ulceration before and after treatment
Tabular analysis was performed on dichotomous variables using the χ² test or Fisher exact test when the expected value of any cell is below five Continuous variables were compared using either the t-test or the WilcoxonMann-Whitney test when the data were not normally distributed Statistical and graphical analyses were conducted using SAS 94 software The significance level for all analyses is set at p less than 005
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 L1375 has been shown to be as effective as mesalamine promoting the secretion of anti-inflammatory cytokines used in the treatment of Crohns 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 CFU5 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 antibioticanti-inflammatory history After obtaining informed consent 60 eligible patients were randomly assigned to two groups n 30group using permuted block randomization with R32 software The Control group received conventional treatment while the Experimental group Colon group received LiveSpo Colon 3 billion CFU5 mL at a dose of 3 ampoulesday-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
Clinical Evaluation
- Interview Conducted via telephone or at the research facility using the IBDQ-32 questionnaire to assess health-related quality of life in patients with IBD ulcerative colitis and Crohns disease The questionnaire covered bowel symptoms BS systemic symptoms SS emotional function EF and social function SF with each question rated from 1 to 7 1 being worst 7 being best Total IBDQ scores ranged from 32 to 224 assessed on Days 0 7 and 30
Sub-clinical Evaluation
Blood Tests 13 hematological indices and 7 biochemical indices were evaluated on Day 30
Colonoscopy Changes before and after treatment were assessed to evaluate lesion characteristics on colonoscopy including redness bleeding swelling and ulcers on Days 7 and 30
Data collection and statistical analysis involved compiling medical records and organizing patient information into a dataset The safety and efficacy of LiveSpo COLON were evaluated by comparing the Control and Colon groups based on changes in biochemical and hematological indicators improvement in IBD symptoms BS SS EF SF and total scores and improvements in colon ulcers redness inflammation bleeding swelling and ulceration before and after treatment
Tabular analysis was performed on dichotomous variables using the χ² test or Fisher exact test when the expected value of any cell is below five Continuous variables were compared using either the t-test or the WilcoxonMann-Whitney test when the data were not normally distributed Statistical and graphical analyses were conducted using SAS 94 software The significance level for all analyses is set at p less than 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None