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CTRI Number  CTRI/2017/07/009170 [Registered on: 31/07/2017] Trial Registered Retrospectively
Last Modified On: 28/05/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Probiotic 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study to evaluate, safety and efficacy of probiotic Unique IS2 in adults suffering from Irritable bowel syndrome in comparison with placebo. 
Scientific Title of Study   A double blind, randomized, placebo-control study to evaluate the effect of Bacillus coagulans supplementation in management of symptoms of IBS. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
IHS/UBL/01/16 Version 1.0 Date: 15-02-2016  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrAnirudh Tripathi 
Designation  Principal Investigator 
Affiliation  Life Veda Treatment and Research Centre 
Address  Life Veda Treatment and Research Centre 7/6, Century Quarters, Next to Doordarshan towers, P.B.road Worli.

Mumbai
MAHARASHTRA
Mumbai-400030
India 
Phone  912224978421  
Fax    
Email  dranirudh_t@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jayanthi Neelamraju 
Designation  Manager- Business Development  
Affiliation  Unique Biotech Ltd. 
Address  Unique Biotech Ltd., G-43, Madhura Nagar, Yousufguda, Hyderabad.

Hyderabad
ANDHRA PRADESH
Hyderabad-500038
India 
Phone  91-4023751346  
Fax    
Email  jayanthi@uniquebiotech.com  
 
Details of Contact Person
Public Query  
Name  Dr Jayanthi Neelamraju 
Designation  Manager- Business Development  
Affiliation  Unique Biotech Ltd. 
Address  Unique Biotech Ltd., G-43, Madhura Nagar, Yousufguda, Hyderabad.

Hyderabad
ANDHRA PRADESH
Hyderabad-500038
India 
Phone  91-4023751346  
Fax    
Email  jayanthi@uniquebiotech.com  
 
Source of Monetary or Material Support  
Unique Biotech Limited Plot No. 2, Phase-II, Alexandria Knowledge Park Kolthur Village, Shameerpet Mandal Ranga Reddy Dist Hyderabad-500 078 India.  
 
Primary Sponsor  
Name  Unique Biotech Limited 
Address  Plot No. 2, Phase-II, Alexandria Knowledge Park Kolthur Village, Shameerpet Mandal Ranga Reddy Dist Hyderabad-500 078 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 = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrAnirudh Tripathi  Life Veda Treatment and Research Centre  Block 7/6, Century Quarters, Next to Doordarshan towers, P.B.road Worli, Mumbai-400030
Mumbai
MAHARASHTRA 		 91-9820180084

dranirudh_t@yahoo.com 
Dr Satyavrat Nanal  Nanal Clinic.  Room no - 102, Anand bhuvan, Gorewadi, Opposite MTNL Colony, Near Matunga Road Railway station, Mahim west, Mumbai – 400016
Mumbai
MAHARASHTRA 		 919892229523

srnanal@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Intersystem Biomedica Ethics Committee  Approved 
Intersystem Biomedica Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Irritable Bowel Syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  One capsule of placebo has to be taken orally per day for 8 weeks. 
Intervention  UBLAC-Containing Bacillus Coagulans Unique IS2 -2 Billion CFU  One capsule of UBLAC is to be taken orally per day for a period of 8 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Subjects of either sex having age group 18-60 years.(Both inclusive)
2.Must include all of the following criteria, (Rome III Criteria)
A. Abdominal discomfort or pain associated with two or more of the following at least 25% of the time:
a)Improvement with defecation
b)Onset associated with a change in frequency of stool
c)Onset associated with a change in the form (appearance) of stool
B. No evidence of an inflammatory, anatomic, metabolic or neoplastic process that explains the subject’s symptoms
3.Weekly average of the worst daily (in the past 24 hours) abdominal pain score of ≥ 3.0 on a 11 point scale.
4.An average of fewer than 3 CSBMs per week. CSBM is defined as a bowel movement, not resulting from use of laxatives that is associated with a sensation of completeness.
5.Able to provide informed consent. 
 
ExclusionCriteria 
Details  1. Participants with a BSS (Bristol Stool Scale) score of 7 (watery, no solid pieces) or 6 (fluffy pieces with ragged edges, a mushy stool) for > 25 % of their BMs during the 12 weeks before screening or, during the run-in period. This does not include BMs that were induced by the use of laxatives.
2. Patients presenting any disease that may affect bowel motility other than the clinical diagnosis of IBS.
3. Presence of rectal bleeding, recent weight loss (greater than 5 kg in the past month) or iron deficiency anemia.
4. History of lactose intolerance and other malabsorption syndromes (e.g. fructose malabsorption).
5. Previous abdominal surgery and patients suffering from severe systemic disease.
6. Use of probiotic or another investigational product within 3 months of the screening visit.
7. Pregnant or breast-feeding or planning on becoming pregnant. Women of child-bearing potential not using effective contraception.
8. Use of any antibiotic drugs (e.g., neomycin, rifaximin) within 1 month of screening.
9. Daily use of laxative within 1 month of screening.
10. Current use, or use within the past 3 months, of narcotics or other medications for IBS symptom management (e.g. alosetron, tegaserod, lubiprostone, antispasmodics, antidiarrheals). 
 
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.Reduction of abdominal discomfort / pain intensity – assessed by physician (Baseline and Week 6, Week 10, and Week 12)
2. An increase of at least one complete spontaneous bowel movement per week from baseline; during the same week, for at least 4 out of 8 weeks of the intervention period.
 		 1.Reduction of abdominal discomfort / pain intensity – assessed by physician (Baseline and Week 6, Week 10, and Week 12)
2. An increase of at least one complete spontaneous bowel movement per week from baseline; during the same week, for at least 4 out of 8 weeks of the intervention period.
 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
1.Overall change in severity of symptoms (Baseline, Week 6, Week 10)
2.Abdominal discomfort (Baseline, Week 6, Week 10)
3.Relief of stool disturbance – number and consistency (Baseline Week 6, Week 10 and Week 12)
4.Rescue/Concomitant medication (Baseline and Week 6, Week 10 ,week 12 )
5.Adverse event (Week 6, Week 10 and week 12) 		 1.Overall change in severity of symptoms (Baseline, Week 6, Week 10)
2.Abdominal discomfort (Baseline, Week 6, Week 10)
3.Relief of stool disturbance – number and consistency (Baseline Week 6, Week 10 and Week 12)
4.Rescue/Concomitant medication (Baseline and Week 6, Week 10 ,week 12 )
5.Adverse event (Week 6, Week 10 and week 12) 
6. Evaluation of serum cytokines- Tumor necrosis factor alpha (TNF α), Interferon gamma (IFN γ), Interleukin 6 (IL- 6), Interleukin 10 (IL-10) and Interleukin 12 (IL-12)  6.Baseline, Week 10 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "136"
Final Enrollment numbers achieved (India)="136" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   21/07/2016 
Date of Study Completion (India) 19/08/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   To investigate effect of UBLAC  (Bacillus coagulans Unique IS2 - Probiotic) supplementation versus placebo on Irritable Bowel Syndrome subjects for the management of symptoms in subjects, in a double-blind, randomized controlled study. 
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