Effects of Bacillus Clausii with IBS-Diarrhea patients
Scientific Title of Study
A Prospective, Randomized, Double-Blind, Placebo-controlled, Parallel
Group-Clinical trial to evaluate the effects of Bacillus Clausii based
product in patients with IBS-Diarrhea
Trial Acronym
Nil
Secondary IDs if Any
Secondary ID
Identifier
BSP-25-071 [Version 1.0, dated 17 April 2025 ]
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Bhimaray Katageri
Designation
Principal Investigator
Affiliation
Shri. B. M. Patil Medical College, Hospital & Research Centre
Address
Room No. 2, 3rd Floor, Department of Gastroenterology Shri. B. M. Patil Medical College, Hospital & Research Centre, Bangaramma Sajjan Campus, Solapur Road, Vijayapura-586103, Karnataka
S K Biobiz Pvt Ltd, Unit I, G1-G5, Sancheti Ware housing Complex, 10th
Mile, Mumbai Agra Road, Jaulke, Tal. Dindori, Nashik
422206. Maharashtra, India
Primary Sponsor
Name
S K Biobiz Pvt Ltd
Address
Unit I, G1-G5, Sancheti Ware housing Complex, 10th
Mile, Mumbai Agra Road, Jaulke, Tal. Dindori, Nashik
422206. Maharashtra, India.
Type of Sponsor
Other [Biotechnology company]
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 Bhimaray Katageri
Shri B.M. Patil Medical College, Hospital and Research Centre
Room No. 2, 3rd Floor, Department of Psychiatry, Bangaramma Sajjan Campus, Solapur Road, Vijayapura-586103, Karnataka State, India Bijapur KARNATAKA
8860106258
muttucdn@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Shri B.M. Patil Medical College, Hospital and Research Centre Institutional Ethics Committee
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
Comparator Agent
SKB 101 (White crystalline free flowing Powder)
twice a day for 60 days
Intervention
SKB_BCL21 (Bacillus clausii 2×109 cfu/g) White crystalline free flowing Powder
twice a day for 60 days
Inclusion Criteria
Age From
18.00 Year(s)
Age To
60.00 Year(s)
Gender
Both
Details
Male and female subjects aged between 18 and 60 years.
2. Subjects presenting with acute diarrhea, defined as the
occurrence of three or more loose stools per day for a duration
of less than 72 hours, accompanied by clinical symptoms such
as bloating, abdominal pain, or other related gastrointestinal
discomfort.
3. Subjects must meet the Rome IV criteria for mild to moderate
IBS-D, characterized by recurrent abdominal pain occurring, on
average, at least one day per week in the last three months, with
symptom onset at least six months prior to diagnosis. The
condition must also be associated with at least two of the
following:
a) Symptoms related to defecation
b) Onset of symptoms associated with a change in stool frequency
c) Onset of symptoms associated with a change in stool form
(appearance)
4. Subjects must present with stool types classified as Type 6 or
Type 7 on the Bristol Stool Chart, indicating the presence of
loose or watery stools, suggestive of gastrointestinal
disturbances such as diarrhea.
5. Subjects must not have any severe health conditions that could
significantly affect gut health, including major gastrointestinal
disorders that may confound study outcomes.
6. Subjects must demonstrate the ability and willingness to provide
written informed consent for participation in the study.
ExclusionCriteria
Details
1.Patients requiring the use of antibiotics either in medicine form of natural e.
grapefruit seed extract, olive leaf extract, oil of oregano, colloidal silver and highly
concentrated garlic preparations.
2.Exercise and the use of complementary and alternative medicine for IBS symptoms (i.e.
peppermint oil, cognitive behavior therapy) during the study should be maintained at
the same level prior to the study. The patient will be excluded from the study if
assessment by the treating investigator showed evidence for cardiovascular, respiratory,
urogenital, gastrointestinal/hepatic, hematologic/immunologic, head, ears, eyes, nose
and throat, dermatologic/psychiatric, allergy, major surgery or other diseases as
revealed by history, physical examination and existing laboratory assessments which
may interfere with the administration.
3.Pregnant or lactating women.
4.Females at childbearing age will be excluded unless they are using acceptable birth
control measures i.e. implants, injectables, combined oral contraceptives, some
intrauterine contraceptive devices, sexual abstinence or a vasectomized partner.
5.Patients requiring treatments with non-permitted medication i.e. 5-HT3 antagonist,
spasmolytics, anticholinergics, cholestyramine, anti-flatulence agents,
metoclopramide, gastric-anti secretory agents proton pump inhibitors; for indications
other than Gastroesophageal Reflux Disease GERD, narcotics, anti-diarrheal drugs,
and systemic steroids.
6. Patients exceeding the treatment limits of permitted medication more than 2
days per week during the study period: alginate, antacids and analgesics limited to
acetaminophen less than or 1000 mg/day, acetylsalicylic acid or NSAIDS no more than 2
tablets/day), (stable dose throughout the study period, anti-depressants (must be on a
stable dose 3 months), fiber supplements, psyllium hydrophilic mucilloid, gastric
antisecretory agents (only for GERD patients who are on a stable dose 3 months;
patients should be able to differentiate between IBS and GERD symptoms),
acetylsalicylic acid less than or equal to 325 mg/day, sedatives. Deliverance medications: Mild laxatives
only if necessary. Any other medications can be used without limits based on the
clinical judgment of the treating investigator.
7. Being in another clinical trial 4 weeks before entering the study.
8.Constipated IBS patients.
9. IBS-Diarrhea patients with un-treated lactose intolerance.
10.10. Regular use of probiotics or using other probiotics during the study.
11. Patients are allergic to milk or soy products.
12. Patients using catheters.
13. Patients presented with rectal bleeding, weight loss, iron deficiency anemia, nocturnal
symptoms and a family history of colorectal cancer, inflammatory bowel disease and
celiac spruce.
14. Patients who have allergies for the active ingredients or any of the excipients
15. Patients presented with any immune-compromised condition such as AIDS,
lymphoma, long term corticosteroid treatment
16. Patients presented with nausea, vomiting and fever.
Method of Generating Random Sequence
Other
Method of Concealment
Other
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
Reduction in the severity and frequency of abdominal pain, assessed.
2. Improvement in stool consistency as measured by the Bristol Stool
Chart, with a shift towards normal stool types (Types 3–5),
evaluated across both groups.
3. Improvement in patient-reported overall symptom relief, assessed
using a standardized IBS symptom questionnaire, with comparative
analysis between the two groups.
using a validated pain intensity scale (Visual Analog Scale),
comparing outcomes between the intervention and placebo groups
Day 1;Day 30; Day 60
Secondary Outcome
Outcome
TimePoints
1.Incidence of adverse events (AEs) and serious adverse events
(SAEs) throughout the study duration, compared between the
intervention and placebo groups.
2. Changes in vital signs, laboratory parameters, and physical
examination findings from baseline to the end of the study, analysed
for differences between groups
Day 1;Day 30; Day 60
Target Sample Size
Total Sample Size="46" Sample Size from India="46" 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 2/ Phase 3
Date of First Enrollment (India)
31/07/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
31/07/2025
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="0" Months="6" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Open to Recruitment
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
IBS is a functional bowel disorder characterized by symptoms of abdominal pain or discomfort and associated with disturbed defecation. The symptoms of IBS have a physiological basis. Although no specific physiological mechanism is unique to, or characterizes IBS, there are at least 3 interrelated factors that affect symptoms to varying degrees in individuals with IBS: (1) altered gut reactivity (motility, secretion) in response to luminal (e.g., meals, gut distention, inflammation, bacterial factors) or provocative environmental (psychosocial stress) stimuli, resulting in symptoms of diarrhea and/or constipation; (2) a hypersensitive gut with enhanced visceral perception and pain; and (3) dysregulation of the brain-gut axis, possibly associated with greater stress-reactivity and altered perception and/or modulation of visceral afferent signals.
Nearly 12 percent of patients seek medical care in primary care practices for IBS related complaints. Studies have demonstrated that the prevalence of IBS ranges between ten and fifteen percent; however, the majority of these patients do not seek medical care. IBS is most prevalent in South America at approximately 21 percent and least prevalent in Southeast Asia at 7 percent. In the United States, Canada, and Isreal, IBS symptoms are 1.5 to 2 times more prevalent among women than men. Moreover, women are more likely to report abdominal pain and constipation, whereas men are more likely to report diarrhea. The prevalence of IBS also decreases with age. IBS can also be broken down into more specific diagnoses, which include IBS with diarrhea (IBS-D), IBS with constipation (IBS-C), and IBS with mixed bowel patterns (IBS-M). The prevalence of these three diagnoses differs in the United States versus Europe. In the United States, there is an equal distribution of these diagnoses, whereas, in Europe, IBS C or IBS-M can be more prevalent