| CTRI Number |
CTRI/2014/03/004502 [Registered on: 26/03/2014] Trial Registered Retrospectively |
| Last Modified On: |
10/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To evaluate the safety and efficacy of LactoSpore® vs. Placebo in patients with diarrhea predominant Irritable Bowel Syndrome. |
|
Scientific Title of Study
|
A randomized, double blind, parallel group, placebo controlled study to evaluate the safety and efficacy of LactoSpore® (Bacillus coagulans) in patients with diarrhea predominant Irritable Bowel Syndrome. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Srinivasa M |
| Designation |
Principal Investigator |
| Affiliation |
Mysore Medical College and Research Institute, KR Hospital |
| Address |
Mysore Medical College and Research Institute, KR Hospital, Irwin Road, Mysore
Mysore
KARNATAKA
570001
India |
| Phone |
|
| Fax |
|
| Email |
drsrinivasam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Suresh Karri |
| Designation |
Senior Manager |
| Affiliation |
Clinworld Private Limited |
| Address |
19/1, 19/2, I Main, II Phase, Peenya Industrial Area, Bangalore, Karnataka
Bangalore
KARNATAKA
560058
India |
| Phone |
91-22-66981992 |
| Fax |
91-22-66981994 |
| Email |
suresh@clinworld.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepa Subramanian |
| Designation |
Chief Executive Officer |
| Affiliation |
Syncretic Clinical Research Services |
| Address |
#4, 5th Cross, 11th Main Road, Vasanthnagar, Bangalore
Bangalore
KARNATAKA
560052
India |
| Phone |
|
| Fax |
|
| Email |
deepa@syncretic.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sabinsa Corporation |
| Address |
20 Lake Drive,
East Windsor,
NJ 08520 USA
|
| Type of Sponsor |
Other [Marketer and manufacturere of phytonutrients, ayurvedic, herbal extracts, probiotics etc.] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Balraj KP |
Kempegowda Institute of Medical Sciences |
Department of Medicine, KIMS Hospital, KR Road, VV Puram, Bangalore
Bangalore
KARNATAKA |
08026613225
drkpbalaraj@gmail.com |
| Dr Srinivasa M |
Mysore Medical College and Research Institute, KR Hospital |
Department of Medicine, Mysore Medical College and Research Institute, KR Hospital, Irwin Road, Mysore 570001
Bangalore
KARNATAKA |
08212520521
drsrinivasam@gmail.com |
| Dr Chandrahas PT |
Sapthagiri Institute of Medical Sciences and Research Center |
Department of Medicine, Sapthagiri Institute of Medical Sciences and Research Center, No.15, Chikkasandra, Hesarraghatta Main Road, Bangalore
Bangalore
KARNATAKA |
08028393392
drchandrahas1973@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, KIMS Hospital |
Approved |
| Institutional Ethics Committee, Mysore Medical College and Research Institute and Associated Hospitals |
Approved |
| Institutional Ethics Committee, Sapthagiri Institute of Medical Sciences and Research Center |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Diarrhea predominant Irritable Bowel Syndrome, (1) ICD-10 Condition: K580||Irritable bowel syndrome with diarrhea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LactoSpore® - containing Bacillus coagulans SBC37-01, MTCC 5856 – 2 Billion spores |
One tablet of LactoSpore to be taken orally along with the standard treatment for 90 days |
| Comparator Agent |
Placebo |
One Tablet to be taken orally along with standard treatment for 90 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female subjects ranging in age from 18 to 55 years (both inclusive) diagnosed as having gastro intestinal disorders and based on the medical history record will be included in the study by the Investigator.
2. Fulfilling Rome III Diagnostic Criteria for Functional IBS (Functional Diarrhea) 16. Criterion fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis
a) Recurrent abdominal pain or discomfort (uncomfortable sensation not described as pain) at least 3 days/month in the last 3 months associated with two or more of the following:
i. Improvement with defecation
ii. Onset associated with a change in frequency of stool
iii. Onset associated with a change in form (appearance) of stool
b) Recurrent feeling of bloating or visible distension at least 3 days/month in the last 3 months
c) Loose (mushy) or watery stools without pain occurring in at least 75% of stools
3. Willingness to follow the protocol requirement as evidenced by written, informed consent.
4. Willingness to complete subject diaries and respond to study questionnaires.
5. Agree not to use any medication (prescription and over the counter), including vitamins and minerals, during the course of this study.
6. Agree not to use any yogurt during the course of this study.
7. Subjects whose blood chemistries are within a normal range or not considered clinically significant if outside the normal range.
8. Subject’s assurance that they have not taken antibiotics or other drugs whose primary site of action is in the GIT for a period up to 1 month prior to the start of the study. |
|
| ExclusionCriteria |
| Details |
1. Sufficient criteria for a diagnosis of functional dyspepsia or other functional GI disorder.
2. Any clinically significant medical history, medical finding or an ongoing medical or psychiatric condition exists which in the opinion of the Investigator could jeopardize the safety of the subject, impact validity of the study results or interfere with the completion of study according to the protocol.
3. Significant abnormal findings as determined by baseline history, physical examination, vital signs (blood pressure, pulse rate, respiration rate) hematology, serum chemistry, urinalysis.
4. History or presence of significant alcoholism or drug abuse in the past one year.
5. Participation in a clinical study during the preceding 90 days.
6. History of malignancy or other serious disease.
7. Any contraindication to blood sampling.
8. Smoking or Consumption of tobacco products.
9. Blood or blood products donated in past 30 days prior to study supplement administration.
10. Female subjects on pregnancy and lactating women. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Safety Outcome -
1] Physical Examination and vitals
2] Assessment of reported adverse events, if any
3] Assessment for any abnormal laboratory parameters
Efficacy Outcomes -
1] Self assessment of abdominal pain, measured on a 10 cm VAS
2] Bloating and distension, measured by Gastro intestinal discomfort questionnaire
3] Subjective evaluation using Bristol Stool Form Score
|
Safety Outcome -
1] Physical Examination and vitals (Screening, Day 0, Day 30, Day 60 and Day 90)
2] Adverse events, if any (All visits)
3] Abnormal laboratory parameters (Screening and Day 90)
Efficacy Outcomes -
1] 10 cm VAS (Day 0, Day 30, Day 60 and Day 90)
2] Gastro intestinal discomfort questionnaire(Day 0, Day 30, Day 60 and Day 90).
3]Bristol Stool Form Score(Day 0, Day 30, Day 60 and Day 90).
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1] Physicians Global Assessment
2] Irritable Bowel Syndrome Quality of Life Questionnaire
3] Pathogenic bacterial count in stools
|
1] Physicians Global Assessment(Day 0, Day 30, Day 60 and Day 90)
2] IBS QOL Questionnaire(Day 0, Day 30, Day 60 and Day 90).
3] Stool bacterial count(Screening and Visit 4). |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/02/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A randomized, double blind,
parallel group, placebo controlled study to evaluate the safety and efficacy of
LactoSpore® (Bacillus coagulans) in patients with diarrhea predominant
Irritable Bowel Syndrome and will be conducted in 3 centers in India. The Primary
outcome will be to access the safety and efficacy of LactoSpore® (Bacillus
coagulans) for a treatment period of 90 days. 36 randomized patients will be
given a tablet each either of LactoSpore® or a placebo. Study evaluations will
be conducted as per the study protocol. All adverse events will be recorded and
safety parameters evaluated. |