| CTRI Number |
CTRI/2018/02/011654 [Registered on: 01/02/2018] Trial Registered Prospectively |
| Last Modified On: |
19/05/2020 |
| 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 Clinical Study to Evaluate the Effectiveness and Safety of Bacillus coagulans LBSC in Patients with Irritable Bowel Syndrome. |
|
Scientific Title of Study
|
A Prospective, Interventional, Randomized, Double-blind and Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of Bacillus coagulans LBSC in Subjects with Irritable Bowel Syndrome. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| ICBio/CR/AETL/1118/79 version 02 Dated 13 Dec 2018 |
Protocol Number |
| ICBio/CR/AETL/1118/79 Version: 01 Dated: 07 Dec 2017 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Vijaya Kumar N |
| Designation |
General Physician |
| Affiliation |
Sri Venkateshwara Hospital |
| Address |
Department of Internal medicine # 86 Hosur Main road, Madiwala Bangalore-560068
Bangalore
KARNATAKA
560068
India |
| Phone |
09448116114 |
| Fax |
|
| Email |
vayanur.1959@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harisha s |
| Designation |
Director operations |
| Affiliation |
ICBio Clinical Research Pvt. Ltd. |
| Address |
#16 & 18, ICBio Tower, Yelahanka Main Road, Chikkabettahalli, Vidyaranyapura
Bangalore
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harisha s |
| Designation |
Director operations |
| Affiliation |
ICBio Clinical Research Pvt. Ltd. |
| Address |
#16 & 18, ICBio Tower, Yelahanka Main Road, Chikkabettahalli, Vidyaranyapura
Bangalore
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
|
Source of Monetary or Material Support
|
| Advanced Enzymes Technologies Ltd 5TH Floor, A-Wing, Sun Magnetica, LIC Service Road Louiswadi, Thane (W) - 400 604, India |
|
|
Primary Sponsor
|
| Name |
Advanced Enzymes Technologies Ltd |
| Address |
5TH Floor, A-Wing, Sun Magnetica, LIC Service Road Louiswadi, Thane (W) - 400 604, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Vijaya G |
People Tree Hospitals Clinical Research |
People Tree Hospitals Clinical Research
# 2 Tumkur Road, Goraguntepalya, (Next to Yeshwanthpura Metro Station) Bangalore- 560022 Karnataka, India
Bangalore
KARNATAKA |
8867655769
research@peopletreehospitals.com |
| Dr Vijaya Kumar N |
Sri Venkateshwara Hospital |
Department of Internal medicine
# 86 Hosur Main road, Madiwala
Bangalore-560068
KARNATAKA
Bangalore
KARNATAKA |
09448116114
vayanur.1959@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| PEOPLE TREE HOSPITALS ETHICS COMMITTEE |
Approved |
| Sri Venkateshwara Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Irritable Bowel Syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lactic Acid Bacillus |
Pharmaceutical form: Powder Dosing schedule in the study: 2 Billion colony forming unit by reconstituting in 100 ml water; twice-thrice daily prior to meal. |
| Comparator Agent |
Placebo |
Pharmaceutical form: Powder Dosing schedule in the study: 2 Billion colony forming unit by reconstituting in 100 ml water; twice-thrice daily prior to meal. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and females aged 18 and 65 yrs. completed years (both inclusive) with diagnosis of IBS as per Rome IV criteria with following symptoms for more than 3 months
2. Abdominal discomfort such as mild pain, cramping, bloating,
3. Altered bowel habit indicated by frequent diarrhea or constipation
4. Functional dyspepsia
3. Written informed consent by study participants
|
|
| ExclusionCriteria |
| Details |
1. On antibiotics or laxatives within the preceding 6 weeks.
2. Presence of inflammatory bowel disease
3. Presence of acute GI tract infection
4. Presence of fever, abdominal mass, signs of bowel obstruction
5. History of colon cancer or diverticulitis
6. Infection by human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus
7. Patients with celiac disease defined by biopsy of the duodenal mucosa.
8. History of scleroderma and gastroparesis
9. Hypothyroidism
|
|
|
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. Assessment of change in Gastrointestinal symptoms frequency assessment using DSFQ on 5-point Likert scale.
2. Assessment of change in gastrointestinal symptoms severity using IBS-SSS.
3. Assessment of change in stool consistency using Bristol stool chart
|
Screening to End of Treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment of safety of investigational product:
1. Adverse event
2. Physical examination
3. Biomarker of systemic safety
4. Hematological – CBC
5. Hepatic - SGOT, SGPT
6. Renal - serum creatinine
7. Quality of life questionnaire by VAS assessments
|
Screening to End of Treatment |
|
Target Sample Size
Modification(s)
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
06/02/2018 |
| Date of Study Completion (India) |
24/08/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
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
Modification(s)
|
A Prospective, Interventional, Randomized, Double blind, Placebo Controlled Clinical trial to evaluate the Efficacy and safety of Bacillus coagulans LBSC in Subjects with Irritable Bowel Syndrome.
Total of 40 Subjects was Enrolled for the study to Evaluate the Efficacy and Safety .
Bacillus coagulans LBSC is used in the treatment of Irritable Bowel Syndrome .
|