Inflammatory Bowel DiseasesNCT06637683
Efficacy of LiveSpo COLON as a Supportive Treatment for Inflammatory Bowel Disease (IBD)
A study testing LiveSpo COLON and Routine treatment in people with Inflammatory Bowel Diseases, run by Anabio R&D at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- LiveSpo COLON and Routine treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteVietnam
- Study dates
- 15 Nov 2019to 20 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients did not have the test results and symptoms as described in the inclusion criteria; patients met the inclusion criteria but did not comply with the study procedures
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the 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 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.
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 Crohn's 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 Wilcoxon/Mann-Whitney test when the data were not normally distributed. Statistical and graphical analyses were conducted using SAS 9.4 software. The significance level for all analyses is set at p less than 0.05.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- LiveSpo COLON, Routine treatment
- Keywords
- Inflammatory Bowel Diseases (IBD), Bacillus spore, Crohn's disease, ulcerative colitis, adult
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiveSpo COLONCombination product
LiveSpo® COLON has a registration number: 10401/2019/ĐKSP issued by the Food Safety Department of the Ministry of Health in Vietnam
Routine treatmentOther
The standard internal medicine treatment protocol of the hospital
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Combination Product: LiveSpo COLON |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0 and Day 7 and Day 30
Secondary outcomes (2)
Number of patients with positive changes in colon lesions before and after treatment
Endoscopic images showing changes in colon lesions including red inflammation, bleeding, swelling and ulceration before treatment and after treatment
Measured: Day 0 and Day 30
Number of participants with abnormal laboratory blood test results
Evaluate the safety of LiveSpo COLON by assessing the proportion of patients with abnormal biochemical and hematological indicators Hematological indicators: white blood cell (G/L); red blood cell (T/L); hemoglobin (g/L); Hematocrit (%); Mean corpuscular volume (fL); Mean Corpuscular Hemoglobin (pg); Mean Corpuscular Hemoglobin Concentration (g/L); Red Cell Distribution Width (%); Platelet count (G/L); Mean of hemoglobin red blood cells (pg); Red blood cell Distribution Width - Coefficient of Variation(%); Mean platelet volume (fL); Platelet volume (%).
Biochemical indicators: Glutamate Oxaloacetat Transaminase (U/L), Glutamate Pyruvate Transaminase (U/L),Gamma-Glutamyl Transferase(G/L); Bilirubin (μmol/L): Albumin (g/L); Urea (mmol/L); Creatin (μmol/L).
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start15 Nov 2019
- Primary completion15 Mar 2020
- Study completion20 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, single-blind, controlled clinical trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anabio R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vietstar Biomedical Research, Thai Binh University of Medicine and Pharmacy
- Responsible party
- Sponsor
- Investigators
- Nguyen T Binh, Assoc.Prof., Principal investigator, Thai Binh University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637683
- Sponsor's protocol ID
- COLON 01
- Other IDs
- 1015/GCN YDTB
- Status last verified
- Oct 2024
- First submitted
- 30 Sep 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data or samples share that will be coded, with no PHI include. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party
Publications
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.
PubMed 27825987Moayyedi 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.
PubMed 19091823Lee 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.
PubMed 30353462Horosheva 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
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.
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.
PubMed 31952938Horosheva 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.
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.
PubMed 18438406Miele 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.
PubMed 19174792Yarlas 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.
PubMed 32377552
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06637683
- Acronym / sponsor ID
- COLON 01
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Inflammatory Bowel Diseases (IBD), Bacillus spore, Crohn's disease, ulcerative colitis, adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Anabio R&DIndustry (pharma, biotech, devices)
- Collaborators
- Vietstar Biomedical Research, Thai Binh University of Medicine and Pharmacy
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 20 Jun 2020 (actual)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
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 Crohn's 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 Wilcoxon/Mann-Whitney test when the data were not normally distributed. Statistical and graphical analyses were conducted using SAS 9.4 software. The significance level for all analyses is set at p less than 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- A randomized, single-blind, controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Other: Routine treatmentThe 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. |
| Test group | Experimental | Combination Product: LiveSpo COLONThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients did not have the test results and symptoms as described in the inclusion criteria; patients met the inclusion criteria but did not comply with the study procedures
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiveSpo COLONLiveSpo® COLON has a registration number: 10401/2019/ĐKSP issued by the Food Safety Department of the Ministry of Health in Vietnam | Combination product | Test group |
| Routine treatmentThe standard internal medicine treatment protocol of the hospital | Other | Control group |
Primary outcome
Number of patients with IBD symptoms and score representing the severity of patients' IBD symptoms in control and experiment group
Time frame: Day 0 and Day 7 and Day 30
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.
2 secondary outcomes
Number of patients with positive changes in colon lesions before and after treatment
Time frame: Day 0 and Day 30
Number of participants with abnormal laboratory blood test results
Time frame: Day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Background: PubMed 27825987Lefevre 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: PubMed 19091823Moayyedi 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: PubMed 30353462Lee 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.
- BackgroundHorosheva 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
- BackgroundIsmaeil 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.
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- Individual participant dataSharing planned: Yes. Data or samples share that will be coded, with no PHI include. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nguyen T Binh, Assoc.Prof. principal investigator
Thai Binh University of Medicine and Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LiveSpo COLON and Routine treatment in people with Inflammatory Bowel Diseases, run by Anabio R&D at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with IBD symptoms and score representing the severity of patients' IBD symptoms in control and experiment group (time frame: Day 0 and Day 7 and Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06637683, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.