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CTRI Number  CTRI/2021/08/035889 [Registered on: 24/08/2021] Trial Registered Prospectively
Last Modified On: 30/12/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Other 
Public Title of Study   A clinical study of Probiotic - Bacillus coagulans LBSC in the treatment of drug-induced constipation. 
Scientific Title of Study   A prospective, interventional, randomized, double-blind, parallel, multi-arm, controlled clinical study to evaluate the efficacy and safety of Bacillus coagulans LBSC in the treatment of drug-induced constipation associated with functional gastrointestinal disorder (FGID) symptoms 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
AETL/CT/2020/006, Version 1.0 dated 14-Apr-2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mr Pratik Shah 
Designation  Project Manager 
Affiliation  COD Research Pvt Ltd 
Address  COD Research Pvt Ltd 301, I-Square, Near Shukan Mall, Science City Road, Sola

Ahmadabad
GUJARAT
380060
India 
Phone  9712928386  
Fax    
Email  pratik.s@cod-research.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jignesh H Patel 
Designation  AGM Medical and Regulatory Affairs 
Affiliation  COD Research Pvt Ltd 
Address  COD Research Pvt Ltd 301, I-Square, Near Shukan Mall, Science City Road, Sola

Ahmadabad
GUJARAT
380060
India 
Phone  8422974431  
Fax    
Email  jignesh.p@cod-research.com  
 
Details of Contact Person
Public Query  
Name  Mr Nimesh Parekh 
Designation  Chief Operating Officer 
Affiliation  COD Research Pvt Ltd 
Address  COD Research Pvt Ltd 301, I-Square, Near Shukan Mall, Science City Road, Sola

Ahmadabad
GUJARAT
380060
India 
Phone  9904468245  
Fax    
Email  nimesh.p@cod-research.com  
 
Source of Monetary or Material Support  
Advanced Enzyme Technologies Ltd. 
 
Primary Sponsor  
Name  Advanced Enzyme Technologies Ltd 
Address  5th Floor A-Wing Sun Magnetica LIC Service Road Louiswadi Thane (W) 400 604 Maharashtra (INDIA)  
Type of Sponsor  Other [Nutraceutical] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Govardhan Rao M V  EXCEL HOSPITAL  Department of Medicine, Ground floor 1-5-56/29, Plot No 29, Old Alwal, Near IG Statue, beside Bharat Petroleum, Secunderabad, Telangana - 500010 India
Hyderabad
TELANGANA 		 9440664042

ishnovaclinical@gmail.com 
Dr Nikhil Jillawar  Lifepoint Multispeciality Hospital  Department of Gastroentrology, 4th floor, 145/1 Mumbai Pune Bypass Rd, Near Sayaji hotel, Wakad Pune, Maharashtra 411057 India
Pune
MAHARASHTRA 		 9730475068

lp.feasibility@gmail.com 
Dr Mahesh Swamy  RAMYA HOSPITALS  Department of Medicine, First Floor, Plot No. 8, 9, 10 414/50, Main Road, Old Bowenpally Cross Road, Secunderabad, Telangana - 500011, India.
Hyderabad
TELANGANA 		 9440664042

investigator@ishnovaclinical.com 
Dr Jignesh Patel  Sanjivani Superspeciality Hospital Pvt. Ltd  1, Uday Park Society, Nr. Sunrise Park, Vastrapur, Ahmedabad-380015
Ahmadabad
GUJARAT 		 9727735536

drjigs2712@gmail.com 
Dr T Thrivikram  TX HOSPITAL  Department of Medicine, Ground floor, Near Masjid, Bharat Nagar, Telangana - 500039 India
Hyderabad
TELANGANA 		 9440664042

trivikramtx@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
LPREthicscommittee  Approved 
S2JINDEPENDENTETHICS COMMITTEE(S2J IEC)  Approved 
S2JINDEPENDENTETHICS COMMITTEE(S2J IEC)  Approved 
S2JINDEPENDENTETHICSCOMMITTEE(S2J IEC)  Approved 
Sanjivani Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K590||Constipation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BacilluscoagulansLBSC  Bacillus coagulans LBSC 2 Billion spores / gram per sachet Dose: 2 Billion spores / gram per sachet Frequency: Thrice a day (morning, afternoon and evening) Route of administration: Orally with drinking water Duration of therapy: Approximately 35 days  
Comparator Agent  Placebo (Maltodextrin)  Maltodextrin Dose: 1 g per sachet Frequency: Thrice a day (morning, afternoon and evening) Route of administration: Orally with drinking water Duration of therapy: Approximately 35 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Willing and able to provide written informed consent prior to any study-related activities being performed.
2. Able and willing to comply with the protocol, including availability for all scheduled study visits.
3. Male and Female patients aged 18 to 65 years (both inclusive).
4. Patients diagnosed with
Chronic functional constipation induced by selected classes of drugs followed by Rome IV criteria (refer Appendix 1) [following the International Classification of Diseases, 10th Ed. (ICD-10-CM) Medical Diagnosis Code K59.03.
The constipation is accompanied with FGID symptoms as per Rome III criteria.
Are under treatment with constipation causing drugs for at least 3 months prior to screening.
5. Women of child bearing potential, (defined as women physiologically capable of becoming pregnant, unless they are using effective method of contraception during dosing of the investigational product) practicing any two acceptable methods of contraception. Acceptable methods of contraception are:
Oral or parenteral (injection, patch or implant) hormonal contraception which has been used continuously for at least one month prior to the first dose of study medication
Intrauterine device or intrauterine system
Double barrier method of contraception (Condom and occlusive cap or condom and spermicidal agent)
Male sterilization (at least 6 months prior to the screening, should be the sole male partner for that patient)
Female sterilization (surgical bilateral oophorectomy) or tubal ligation at least 6 weeks prior to study participation
Total abstinence, partial abstinence is not acceptable.
6. Female patients with negative urine pregnancy test (only for female who has not completed 1 year after menopause & have not gone through hysterectomy or bilateral tubal ligation). 
 
ExclusionCriteria 
Details  1. Known hypersensitivity to contents of drug product or related class of drugs or to any of the excipients of the formulation.
2. Addicted alcoholics and/or drug abusers.
3. History or presence of coronary, renal, pulmonary and thyroid disease.
4. Active or a history of inflammatory bowel disease.
5. Has undergone any abdominal surgery, except for hernia repair or appendectomy.
6. Has had active treatment with prescription medication for any of the FGID symptoms within 4 weeks prior to screening.
7. Has been diagnosed with infectious gastroenteritis within 6 weeks prior to screening.
8. Has undergone treatment with probiotics within 6 weeks prior to screening.
9. Has used antibiotics within 14 days prior to screening.
10. Has a known diagnosis of gastroparesis.
11. Has used antipsychotic medications within 3 months prior to screening.
12. Has used systemic steroids within 1 month prior to screening.
13. Has suffered from a major psychiatric disorder within the past 2 years from screening.
14. AST and ALT more than 5 times ULN; Serum bilirubin more than ULN and Platelet Count <95,000/microleter.
15. Difficulty in swallowing and retaining oral formulation.
16. Known HBsAg positive, Anti HCV and HIV positive.
17. Patient has condition or is in a situation which, in the investigator’s opinion, may have put the patient at a significant risk, may have confounded study results, or may have interfered significantly with the patient’s participation in the study.
18. Participation in any other clinical study within 30 days before the first dose of Investigational Product.
19. Pregnant or Lactating female patient. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Change in constipation symptoms based on
occurrence of constipation in %
2.Change in constipation symptoms based on
•Degree of constipation on 4-point likert scale
•Degree of stool consistency
•Occurrence of hard stools in %
•Degree of stool expulsion on 3-point scale
•Defecation frequency (Times/day/person and times/week/person)
•Change in Constipation Scoring System
•Change in FGIDs symptoms based on 4-point Likert scale 		 1.From baseline Day 14 to Day 49
2.From baseline Day 14 to Day 49 
 
Secondary Outcome  
Outcome  TimePoints 
1.Mean change in vital signs
2.Mean change in Laboratory parameters
3.Change in pharmacological parameter evaluated as a mean serum concentration of drug causing constipation
4.Improvement in Health Related Quality of Life (HRQoLs) Questionnaires
•Patient Health Questionnaire 15 item Somatic Symptom Severity Scale (PHQ-15)
•Medical Outcomes Study: 20 Item Short Form Survey (SF-20) 		 1.From baseline Day 14 to Day 49
2.From baseline Day 1 to Day 49
3.From baseline Day 14 to Day 49
4.From baseline Day 14 to Day 49 
Safety Outcome:Number and types of adverse events (AEs) and serious adverse events (SAEs)  Post randomization to Day 60 
 
Target Sample Size   Total Sample Size="168"
Sample Size from India="168" 
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 
Date of First Enrollment (India)   30/08/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The current study is designed as a prospective, interventional, randomized, double-blind, parallel, multi-arm, controlled clinical study. This study involves a screening phase, run-in phase, randomization and treatment phase, and follow-up phase as mentioned below:

       1.Screening phase (Visit 1): Day -14 to -1

       2.Baseline assessment, enrolment and run-in period initiation  (Treatment continuation             with drug inducing constipation; Visit 2): Day 1

       3.Run-in period completion, baseline assessment and day of randomization (Visit 3):                Day 14 ±1 day

        4.Initiation of treatment with test product or its matching placebo: Day  15

        5. Interim follow up 1 (Visit 4): Day 22 ±2 days

        6. Interim follow up 2 (Visit 5): Day 36 ±2 days

        7. End of treatment (Visit 6): Day 50 ±2 days

        8. End of study (telephonic safety call): Day 60 ±2 days

        9. Treatment phase with IPs: 35 Days

 
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