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CTRI Number  CTRI/2021/08/035848 [Registered on: 23/08/2021] Trial Registered Prospectively
Last Modified On: 26/10/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Probiotic 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Probiotika off capsule for the treatment of Irritable Bowel Syndrome 
Scientific Title of Study   A double blind, randomized, parallel group study to evaluate efficacy and safety of Probiotika off capsule against placebo in the treatment of Irritable Bowel Syndrome. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NUTRIN006 Version 2.0 dated 11 Dec 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Abhijit Munshi 
Designation  Director Clinical Operations 
Affiliation  Mittal Global Clinical Trial Services 
Address  Dept. of Clinical Research, First floor, 121B, MANSAROVAR INDL.EST.EXT., INSIDE VISHVAKARMA IND. EST. PANCHLI, BAGHPAT RD, Meerut

Meerut
UTTAR PRADESH
250005
India 
Phone  8937015757  
Fax    
Email  drabhijit@mgcts.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Abhijit Munshi 
Designation  Director Clinical Operations 
Affiliation  Mittal Global Clinical Trial Services 
Address  Dept. of Clinical Research, First floor, 121B, MANSAROVAR INDL.EST.EXT., INSIDE VISHVAKARMA IND. EST. PANCHLI, BAGHPAT RD, Meerut

Meerut
UTTAR PRADESH
250005
India 
Phone  8937015757  
Fax    
Email  drabhijit@mgcts.org  
 
Details of Contact Person
Public Query  
Name  Puneet Mittal 
Designation  Director Clinical Research 
Affiliation  Mittal Global Clinical Trial Services 
Address  Dept. of Clinical Research, First floor, 121B, MANSAROVAR INDL.EST.EXT., INSIDE VISHVAKARMA IND. EST. PANCHLI, BAGHPAT RD, Meerut

Meerut
UTTAR PRADESH
250005
India 
Phone  8937045757  
Fax    
Email  puneetmittal@mgcts.org  
 
Source of Monetary or Material Support  
Nutrin GmbH, Schnaid 36B, 91352, Hallendorf, Germany 
 
Primary Sponsor  
Name  Nutrin GmbH 
Address  Schnaid 36B, 91352, Hallendorf, Germany 
Type of Sponsor  Pharmaceutical industry-Global 
 
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 Mandar Doiphode  AMFs Moraya Multispeciality Hospital  Department of Gastroenterology, Ground Floor, Opp. PMP bus Stop, Powerhouse chowk, Chinchwadgaon, Pune 411033
Pune
MAHARASHTRA 		 9850077168

mandardoiphode22@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee Mysore Medical College and Research Institute  Approved 
Moraya Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K58||Irritable bowel syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo Capsule  One capsule of Placebo per day, Oral use, upto 30 days 
Intervention  Probiotika Off Capsule  One capsule of Probiotika off Per day, Oral use, upto 30 days Contents: Tyndallized LA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Subjects of either sex
2. Age 18 - 65 years (both inclusive)
3. Mild to moderate (using Functional Bowel Disorder Severity Index (FBDSI)) IBS: IBS definition will be based on Rome criteria.
4. Patient is willing to discontinue any laxatives used before the Pretreatment Visit in favor of the protocol-defined Rescue Medicine (bisacodyl tablets or suppositories).
5. Are free of any disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events.
6. If female of childbearing potential, must be willing to practice an acceptable form of birth control for the duration of the study.
7. Are able to give written informed consent in a manner approved by the Institutional Ethics Committee and comply with the requirements of the study.
8. Are willing to avoid participation in any other interventional clinical trial for the duration of this study. 
 
ExclusionCriteria 
Details  1. Are pregnant, breast-feeding, or planning to become pregnant during the study.
2. Patients requiring the use of antibiotics either in medicine form of natural (e.g. grapefruit seed extract, olive leaf extract,
oil of oregano, colloidal silver and highly concentrated garlic preparations)
3. 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)
4. Patients allergic to milk or soy products
5. Patient has a potential central nervous system cause of constipation (e.g., Parkinson’s disease, spinal cord injury, and multiple sclerosis).
6. Patient has ever had a fecal impaction that required hospitalization or emergency room treatment, or has a history of cathartic colon, laxative or enema abuse, ischemic colitis,
or pelvic floor dysfunction (unless successful treatment has been documented by a normal balloon expulsion test).
7. Patient has untreated hypothyroidism or treated hypothyroidism for which the dose of thyroid hormone has not been stable for at least 6 weeks at the time of the
Screening.
8. Have any condition that, in the opinion of the investigator, would confound the safety and/or efficacy assessments.
9. Have participated in any interventional clinical trial in the previous 30 days.
10. Have a known sensitivity to any of the constituents of the test product
11. Have used, are using, or are planning to use immunosuppressive or immunomodulatory medication (i.e., biologics), including oral or parenteral corticosteroids.
12. Have a history of alcohol or illegal drug/substance abuse, or suspected alcohol or illegal drug/substance abuse in the past
2 years. 
 
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 
Comparison of the abdominal
pain relief and changes in stool frequency before and after the treatment, between the two arms. 		 Baseline to Day 30
 
 
Secondary Outcome  
Outcome  TimePoints 
The defecation component of the primary end point will be evaluated by “Bristol stool form scale”.  Baseline and Day 30 
Abdominal pain component of the primary end point will be accessed by using an 10 point numeric rating scale that asks patient daily to rate their abdominal pain over the past 24 hours.  Baseline and Day 30 
quality-of-life parameter as measured by IBSSSS before and after treatments, between 2 arms  Baseline and Day 30 
quality-of-life parameter as measured by EQ5D before and after treatments, between 2 arms  Baseline and Day 30 
quality-of-life parameter as measured by SF12v2 before and after treatments, between 2 arms  Baseline and Day 30 
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
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 3 
Date of First Enrollment (India)   25/08/2021 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
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 a chronic functional gastrointestinal (GI) disorder characterized by recurrent symptoms of abdominal pain and/or discomfort, accompanied by altered bowel function and a feeling of bloating, moderate to severe cases of IBS, an overall deterioration in quality of life (QOL) is often present. An altered gut brain axis has been the main pathogenetic mechanism of IBS, which is associated with GI autonomic nervous system. These alterations may lead to abnormal visceral hypersensitivity and contribute to the symptoms. Gut microbiota plays important role in the maintenance of gut homeostasis by direct bactericidal effect and the evolution of both innate and adaptive immune system. Gut microbiota plays important role in pathogenesis of IBS. This is evident from the fact that IBS occurs more frequently after intestinal infections and antibiotic treatment. Studies have shown the alterations of the intestinal microbiota. Considering the relationship between gut microbiota and inflammation of gut, manipulation of gut microbiota by probiotics appears to be an ideal treatment modality for IBS.

Probiotika off is a medical device which is for use in patients with irritable bowel syndrome. It is intended to relieve the symptoms and pain. Probiotika off is used to treat symptoms of irritable bowel syndrome. Patients suffering from this disease often suffer from urge to defecate, diarrhoea, bloating, flatulence, abdominal pain or constipation. One capsule contains 100 mg Heat-Inactivated Lactobacillus Acidophilus. The maximum daily dose is one capsule. In accordance with the Medical Device Directive 93/42/EEC, it is recommended that after 30 days of use of the medical device, a break of 3-5 days is observed. Probiotika off is a medical device in the form of capsules containing heat-inactivated Lactobacillus acidophilus. Its mode of action is to inhibit the attachment of pathogens to the wall of the gastrointestinal tract. Pathogenic bacteria in the gastrointestinal tract must attach themselves to the wall of the intestine to develop disease syndromes; if heat-inactivated probiotic cells effectively compete with the pathogens for binding sites, the virulence of the pathogens would be reduced.

Heat-treated probiotic cells are able to 
- Protection against enteropathogens 
- Maintaining the integrity of the intestinal barrier
- Competition for resources 
- Elimination of competition through competition for binding sites 

Symptoms caused by irritable bowel syndrome can thus be relieved.  
 
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