Health Condition 1: K318- Other specified diseases of stomach and duodenum
Conditions
Interventions
Intervention1: 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 inspec
Sponsors
Unique Biotech Limited
Eligibility
Inclusion criteria
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: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with a 35-point minimum clinically important difference in the IBS symptom severity score (IBS-SSS)Timepoint: week 12 compared to baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Patients whose total IBS-SSS score decreased by = 50 points at three (4-week) visits. Timepoint: 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.Timepoint: week 12 compared to baseline;Change in IBS-QOL score from baseline to week 12.Timepoint: week 12 compared to baseline;Change in IBS-SSS component scores by 30% at week 12.Timepoint: 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.Timepoint: 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.Timepoint: week 12 compared to baseline;Numerical improvement of frequency of bowel movement stratified by IBS type.Timepoint: 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.Timepoint: 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.Timepoint: week 12 compared to baseline;Differences in intake of additional drugs for IBS symptoms.Timepoint: week 12 compared to baseline;Change in the dysbiosis index and intestinal bacterial profileTimepoint: week 12 compared to baseline;Change in levels of serum levels of zonulin from baseline and week 12.Timepoint: week 12 compared to baseline | — |
Countries
India
Contacts
Public ContactVaneet Jearth
Postgraduate Institute of Medical Education and Research
Outcome results
None listed