| CTRI Number |
CTRI/2023/03/051167 [Registered on: 29/03/2023] Trial Registered Prospectively |
| Last Modified On: |
12/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study to investigate the efficacy and safety of a probiotic named as Bacillus Coagulans BCP92 (MTCC 25460) in adults suffering from irritable bowel syndrome disease. |
|
Scientific Title of Study
|
A Prospective, Interventional, Randomized, Parallel, Double blind, Multicenter, Placebo
controlled, Clinical Study to evaluate the efficacy and safety of Bacillus Coagulans BCP92
(MTCC 25460) in adults with irritable bowel syndrome.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PRPL-IBS-001-2023 Version 1.0 dated 20 Jan 2023 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Sanjay Kumar |
| Designation |
DM Gastroenterologist |
| Affiliation |
Gastrocare, Liver & Digestive Disease Center |
| Address |
Ground Floor, Room No. G1, 120-121, Link Road No. 3, near Personal Branch SBI, E-3, Arera Colony, Bhopal- 462016
Bhopal
MADHYA PRADESH
462016
India |
| Phone |
0755-2420123 |
| Fax |
|
| Email |
sanjaykr.gastro@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Sanjay Kumar |
| Designation |
DM Gastroenterologist |
| Affiliation |
Gastrocare, Liver & Digestive Disease Center |
| Address |
Ground Floor, Room No. G1, 120-121, Link Road No. 3, near Personal Branch SBI, E-3, Arera Colony, Bhopal- 462016
Bhopal
MADHYA PRADESH
402016
India |
| Phone |
0755-2420123 |
| Fax |
|
| Email |
sanjaykr.gastro@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sohel Shaikh |
| Designation |
Development Manager |
| Affiliation |
Pellucid Lifesciences Private Limited |
| Address |
Plot No.: 3538, Phase - 4,
GIDC Industrial Estate,
Chhatral - 382729
Gandhinagar
GUJARAT
382729
India |
| Phone |
9822979295 |
| Fax |
|
| Email |
sohel@pellucidlifesciences.com |
|
|
Source of Monetary or Material Support
|
| Pellucid Lifesciences Private Limited |
|
|
Primary Sponsor
|
| Name |
Pellucid Lifesciences Private Limited |
| Address |
Plot No-3538,Phase-4,GIDC Industrial Estate
Chhatral-382729 Dist - Gandhinagar,Gujarat,India |
| Type of Sponsor |
Other [Fermentation based Biotechnology Company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanjay Kumar |
Gastrocare, Liver & Digestive Disease Center |
Ground Floor, Room No. G1, 120-121, Link Road No. 3, near Personal Branch SBI, E-3, Arera Colony, Bhopal- 462016
Bhopal
MADHYA PRADESH |
0755-2420123
sanjaykr.gastro@gmail.com |
| Dr Sirshendu Pal |
Roy Nursing Home, Siliguri |
Ward 12, Tilak Road, Hakim Para, Siliguri- 734001
Darjiling
WEST BENGAL |
9474875556
sirshendu.slg@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Charak Hospital |
Approved |
| Siliguri Sumita Cancer R.W And E. Society |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K588||Other irritable bowel syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bacillus Coagulans BCP92 (MTCC 25460) |
Bacillus Coagulans BCP92 (MTCC 25460) is a probiotic. It will be given in capsule form with dosage 100 mg.
The total duration of the intervention will be of 84 days. |
| Comparator Agent |
Identical Placebo |
An Identical Placebo will be given to the subjects randomized in the control arm. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Good Physical and medical condition assessed based on the patient history and physical condition.
2.Laboratory test results(complete blood count blood chemistry panel) within normal limits or considered not to be clinically significant by the investigator and negative SARS COV 2 antibody test.
3. A voluntary provided written informed consent.
4. Diagnosis of IBS based on the ROME IV criteria e.g., recurrent abdominal pain at least one day a week for the last three months, associated with two or more of the following symptoms (these should be present for the last three months, with the onset of symptoms six months before diagnosis e.g.recurrent abdominal pain at least one day a week for the last three months, associated with two or more of the following symptoms (these should be present for the last three months, with the onset of symptoms six months before diagnosis.
a. related to defecation.
b. associated with a change in stool frequency and/or
c. associated with a change in stool form (appearance)
5.Patients with any of the following forms of IBS will be included.
a. IBS-D - more than 50% of BSF type 6 and 7 stools, and less than 25% of type 1 and 2 stools.
b. IBS-C - more than 50% of BSF type 1 and 2 stools, with less than 25% of type 6 and 7 stools.
6.At least moderate symptom severity defined as an IBS-SSS score of >175 (5 items, maximum score 500).
7.The following medications are allowed during this study, provided they have been used at a stable dose and for at least 1 month prior to the study
a. Contraceptive pills or intramuscular contraceptives,
b. Hormone replacement therapy (estrogen/progesterone),
c. L-thyroxine.
d. Antidepressants at low doses (up to 25 mg of amitriptyline, nortriptyline, or selective serotonin reuptake inhibitor per day)
e. Antihypertensives at low doses (diuretics, angiotensin converting enzyme inhibitors
f. Angiotensin receptor antagonists
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria:
Patient will be deemed ineligible to participate in the study if he/she fulfils any of the following criteria:
1.Unclassified IBS.
2.Cardiovascular disorders: uncontrolled hypertension (blood pressure >170/100 mmHg), cerebrovascular disease.
3.Respiratory disorders (asthma, chronic obstructive pulmonary disease [COPD].
4.Hepatic impairment (including status post cholecystectomy), renal impairment, and unexplained blood biochemistry abnormalities: serum creatinine levels over twice the upper limit of normal, AST or ALT levels over twice the upper limit of normal.
5.Gastrointestinal conditions other than IBS, including clinical or endoscopic diagnosis of gastroenteritis.
6.Endocrine disorders, including diabetes mellitus (fasting blood glucose >11 mmol/L) and elevated TSH levels.
7.Severe neurological conditions, with psychosis.
8.Malignancy.
9.Pregnancy or breastfeeding.
10.Hypersensitivity to Study Product
11.Lactose intolerance.
12.The use of gastrointestinal motility stimulants or dietary fiber supplements during the 2 weeks preceding the clinical study.
13.The use of antithrombotic drugs.
14.Any surgical procedure scheduled during the clinical study.
15.Current probiotic use and refusal to undergo a 3-month washout period.
16.Antibiotic therapy during the 3 months preceding the study.
17.Being included in another clinical study during the previous 3 months.
18.History of alcohol or substance.
19.Inability to strictly adhere to the protocol.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Changes in severity of IBS symptoms using IBS Severity Scoring System.
2.Improvement or worsening of IBS global symptoms using Global Improvement Scale.
3.Changes in an absolute relief.
4.Assessment of change in Gastrointestinal symptoms frequency assessment using
DSFQ on 5-point Likert scale.
5.Assessment of change in stool consistency using Bristol stool chart.
6.Change in IL-6.
|
Time Frame would be of 4 Weeks,8 Weeks and 12 Weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Change in IBS-related mental stress relief as assessed by Perceived Stress Scale
(PSS).
B. Anxiety levels as assessed by State-Trait-Anxiety-Inventory (STAI).
C.Incidence rates of Treatment – emergent adverse events (TEAEs) and serious
adverse events (SAEs).
D. Self-Assessment of General Health with tolerability of IP.
E. Changes in Quality of Life.
F. Change in daily number of stools (stool frequency to be assessed per IBS sub-type).
G. Time to complete the resolution of abdominal discomfort.
H. Assessment of safety |
Time Frame would be of 4 Weeks,8 Weeks and 12 Weeks. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/04/2023 |
| Date of Study Completion (India) |
23/10/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="24" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
https://journals.lww.com/md-journal/fulltext/2024/08020/role_of_bacillus_coagulans__heyndrickxia.29.aspx |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Irritable bowel syndrome (IBS) is one of the most diagnosed gastrointestinal diseases. IBS, in the absence of any other causative disease, is defined as the presence of abdominal pain or discomfort with altered bowel habits. It is estimated to affect 10%-15% of the Western population and has a large impact on quality of life and direct healthcare costs.Probiotics may influence the IBS symptoms including abdominal pain, bloating, distension, flatulence, altered bowel movements, and gut microbiota.Probiotics also amplify the intestinal tight junctions and stabilize the permeability. Moreover, probiotics stimulate goblet cells to produce mucus to enhance the intestinal barrier function, normalize bowel movements, and reduce visceral hypersensitivity in pediatric and adult patients.Based on data from our previous two studies, we hypothesized that a use of Bacillus Coagulans BCP92 in patients with Irritable when given in sufficient amounts confer a health benefit on the host, assist in the management of dysbiosis and or stabilization of the host microbiota in IBS. |