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 Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Unique Biotech Limited
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Percentage of patients with a 35-point minimum clinically important difference in the IBS symptom severity score (IBS-SSS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Double
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Percentage of patients with a 35-point minimum clinically important difference in the IBS symptom severity score (IBS-SSS)
Time Frame: week 12 compared to baseline
Secondary Outcomes
- Patients whose total IBS-SSS score decreased by ≥ 50 points at three (4-week) visits.
- 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)
Investigators
Vaneet Jearth
Postgraduate Institute of Medical Education and Research