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CTRI Number  CTRI/2025/01/079067 [Registered on: 20/01/2025] Trial Registered Prospectively
Last Modified On: 18/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Probiotic 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Efficacy and safety of Bacillus clausii UBBC-07 in adult patients with irritable bowel syndrome (IBS) 
Scientific Title of Study   Evaluation of the efficacy and safety of Bacillus clausii UBBC-07 in comparison with placebo in the treatment of irritable bowel syndrome (IBS)—a 12-week double-blind randomized controlled trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vaneet Jearth 
Designation  Assistant Professor 
Affiliation  Postgraduate Institute of Medical Education and Research 
Address  Department of Gastroenterology, Room no. 20, F Block, Nehru Building, PGIMER

Chandigarh
CHANDIGARH
160012
India 
Phone  8427550317  
Fax    
Email  vaneet.jearth@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Vaneet Jearth 
Designation  Assistant Professor 
Affiliation  Postgraduate Institute of Medical Education and Research 
Address  Department of Gastroenterology, Room No. 20, F Block, Nehru Building, PGIMER

Chandigarh
CHANDIGARH
160012
India 
Phone  8427550317  
Fax    
Email  vaneet.jearth@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Vaneet Jearth 
Designation  Assistant Professor 
Affiliation  Postgraduate Institute of Medical Education and Research 
Address  Department of Gastroenterology, Room No. 20, F Block, Nehru Building, PGIMER

Chandigarh
CHANDIGARH
160012
India 
Phone  8427550317  
Fax    
Email  vaneet.jearth@gmail.com  
 
Source of Monetary or Material Support  
Unique Biotech Limited (UBL), Plot No-2, Phase-II, M.M. Park, Kolthur village, Shameerpet Mandal, Hyderabad 500101, India 
 
Primary Sponsor  
Name  Unique Biotech Limited 
Address  Plot No-2, Phase-II, M.N. Park, Kolthur village, Shameerpet Mandal, Hyderabad-500101, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vaneet Jearth  Postgraduate Institute of Medical Education and Research  Department of Gastroenterology, Room no. 20, F block, Nehru building
Chandigarh
CHANDIGARH 
8427550317

vaneet.jearth@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee ,PGIMER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K318||Other specified diseases of stomach and duodenum,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bacillus clausii UBBC-07 (suspension)   Bacillus clausii spores, which are produced by Unique Biotech, are available in a 5 ml oral suspension that appears to be water upon visual inspection. 5 mL vials containing an oral suspension of Bacillus clausii with a concentration of 4 billion colony-forming units (CFU) per dose will be given to patients once a day in the intervention group for 12 weeks. 
Comparator Agent  Placebo  Placebo will be water provided in the same vials as the interventional drug for a total duration of 12 weeks to patients randomized to the placebo group.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Written informed consent of the subject to participate.
Participants who will meet the Rome IV criteria for IBS
IBS Severity Scoring System (IBS-SSS) score of more than or equal to 150 and abdominal pain (more than or equal to 4 on an 11-point numerical rating scale) on at least 2 days during the 2-week run-in phase.
Men and women, more than or equal to 18 and less than or equal to 65 years
The patient consents to adhere to the instructions to avoid modifications in lifestyle and dietary habits.
Patients agree to take only rescue medicine for their symptoms as per IBS subtype.
 
 
ExclusionCriteria 
Details  Exclusion criteria:
Patients with organic gastrointestinal disorders will be excluded from this trial. Exclusion will be based on a combination of tests, including a full blood count, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), celiac serology, thyroid profile, renal and liver function tests, HIV serology, and fecal calprotectin.
Other exclusion criteria include:
Previous intolerance and/or adverse reactions to probiotics or the use of these products within the preceding 1 month
Pregnancy or lactation
Major systemic diseases (e.g., heart failure, renal failure, malignant tumors, liver cirrhosis, etc.)
Previous or current significant psychiatric comorbidity
Intake of antipsychotics three months prior to study start or systemic corticosteroids within one month prior to study start.
Use of antibiotics in the preceding 1 month.
Patient on any specific diet.
Use of IBS medication within the previous 1 month, except for bisacodyl and loperamide.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Percentage of patients with a 35-point minimum clinically important difference in the IBS symptom severity score (IBS-SSS)   week 12 compared to baseline  
 
Secondary Outcome  
Outcome  TimePoints 
Patients whose total IBS-SSS score decreased by ≥ 50 points at three (4-week) visits.
 
Week 12 compared to baseline 
Improvement of abdominal pain by at least 30% on an 11-point NRS for at least 6 weeks out of a 12-week period.  week 12 compared to baseline  
Change in IBS-QOL score from baseline to week 12.  week 12 compared to baseline  
Change in IBS-SSS component scores by 30% at week 12.  week 12 compared to baseline  
Subjective global assessment of relief of IBS symptoms as a dichotomous outcome, with response defined as reporting IBS symptoms are completely, considerably, or somewhat relieved.  week 12 compared to baseline 
Response rate based on a combination of improvement of abdominal pain by at least 30% and improvement by at least 1 spontaneous bowel movement per week for IBS-C patients.  week 12 compared to baseline  
Numerical improvement of frequency of bowel movement stratified by IBS type.  week 12 compared to baseline  
Response rate based on a combination of at least 30% improvement of abdominal pain and at least 50% decrease of days with stool consistency of 6-7 on a Bristol Stool Form Scale for IBS-D patients.  week 12 compared to baseline  
Response rate based on an increase of one point on a 7-point Likert scale for individual subjective irritable bowel symptoms: abdominal pain, pain during bowel movement, flatulence/bloated stomach, and the urgency to go to the toilet.  week 12 compared to baseline  
Differences in intake of additional drugs for IBS symptoms.  week 12 compared to baseline  
Change in the dysbiosis index and intestinal bacterial profile  week 12 compared to baseline  
Change in levels of serum levels of zonulin from baseline and week 12.  week 12 compared to baseline  
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/03/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

It is currently supposed that gut microbiota dysbiosis may be a potential trigger for IBS, inducing most of the pathological conditions. Thus, the modulation of dysbiotic intestinal microbiota by biologically active biotics, including probiotics, prebiotics, and, when combined, synbiotics, is a promising treatment approach in IBS. Recent meta-analysis including 20 studies involving 3011 patients reported that probiotics are effective and safe for IBS patients; however, definite conclusions are challenging due to the high heterogeneity [1]. They also reported an unmet need for large-scale, well-designed, and rigorous trials to confirm their effectiveness in IBS [1]. The efficacy of probiotics in IBS also depends upon the type of strain selected for therapy. A systematic review and meta-analysis published in 2020 showed that single-strain formulations, particularly those containing Bifidobacterium or Lactobacillus strains, may be more effective in IBS patients [2]. There is evidence to suggest species/strain-specific effectiveness in IBS patients, which further underlines the role of proper selection of probiotics for the best approach according to patients’ specific needs [3]. As an effective treatment for IBS patients, spore-based Bacillus spp. probiotics have been reported in a recent study [4]. The safety and efficacy of Bacillus clausii UBBC-07 have been reported in multiple studies for diarrhea and oral mucositis [5-9]. However, the role of this single strain has not been reported in IBS patients. Therefore, we planned this study to explore the safety and efficacy of Bacillus clausii UBBC-07 in patients with IBS.

 
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