| CTRI Number |
CTRI/2011/08/001944 [Registered on: 09/08/2011] Trial Registered Retrospectively |
| Last Modified On: |
01/12/2011 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Role of healthy bacteria in ulcerative colitis. |
|
Scientific Title of Study
|
"A Randomized control trial to study the effect of oral probiotic versus placebo in patients with ulcerative colitis on clinical/endoscopic response intestinal permeability and fecal and serum markers of mucosal inflammation in addition to standard therapy" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bikash Medhi |
| Designation |
Additional Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Pharmacology
Post Graduate Institute of Medical Education and Research
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
0172-2755250 |
| Fax |
0172-2744043 |
| Email |
drbikashus@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bikash Medhi |
| Designation |
Additional Professor |
| Affiliation |
PGIMER |
| Address |
Department of Pharmacology
PGIMER
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
0172-2755250 |
| Fax |
0172-2744043 |
| Email |
drbikashus@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Bikash Medhi |
| Designation |
Additional Professor |
| Affiliation |
PGIMER |
| Address |
Department of Pharmacology
PGIMER
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
0172-2755250 |
| Fax |
0172-2744043 |
| Email |
drbikashus@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Biotechnology |
|
|
Primary Sponsor
|
| Name |
Department of Biotechnology |
| Address |
Ministry of Science and Technology
Block 2, 6-8th Floors
CGO Complex Lodi Road,
New Delhi-110003 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rakesh Kochhar |
Department of Gastroenterology |
Room no 3018
Post Graduate Institute of Medical Education and Research
Chandigarh
Chandigarh
CHANDIGARH |
0172-2756608
0172-2744401
dr_kochhar@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee PGIMER chandigarh India |
Approved |
| InstituteEthicsCommittee(IEC),PGIMER,Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Active Ulcerative colitis disease , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo (Lactose) |
Placebo will be orally administered daily for a period of 12 weeks |
| Comparator Agent |
Placebo (Lactose) |
Placebo will be administered daily for a period of 12 weeks |
| Intervention |
VSL#3 |
VSL# 3(450 billion CFU) will be orally administered daily for a period of 12 weeks |
| Intervention |
VSL#3 |
VSL#3 (3600 billion CFU) will be administered daily for a period of 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Active disease at presentation |
|
| ExclusionCriteria |
| Details |
Patient should not be on antibiotic, NSAIDs or indigenous medicine
Pregnant or lactating mother
Any patient who received probiotic in the preceding 4 weeks
Patient with life threatning cardiac, renal, pulmonary or cardiovascular disease
Inability to obtain informed consent
Severe disease requiring hospitalization /steroids /anti-cytokine therapy
Patient taking antiplatelet drugs
Patient with uncontrolled diabetes
patient with gall stone disease
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Response will be defined as reduction of atleast 3 points in the UCDAI from the baseline value at 12 weeks; reduction in the activity score of inflammation |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in intestinal permeability
Reduction in faecal and serum inflammatory markers |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
20/05/2011 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Intestinal inflammation seen in Inflammatory bowel disease (IBD) results from an altered mucosal immune response to luminal bacterial antigens. Current research suggests that an inappropriate and persistent immuno response against commensal intestinal bacterial flora plays a pivotal role in the pathogenesis of chronic Inflammatory bowel disease . It also has been proposed that the signs and symptoms of IBD may be mediated by the increased intestinal permeability secondary to low grade inflammation in the gut mucosa. Increased intestinal permeability results in further exposure of underlying intestinal mucosa to luminal bacteria and antigens perpetuating the intestinal inflammation. Thus restoring intestinal permeability rather than only reduction of mucosal inflammation would thus be a desirable endpoint in the restoration of mucosal integrity and would be the harbinger of better long term outcome. Many clinical trials have shown that probiotics may have beneficial effect on IBD patients. Probiotics are hypothesized to work by several mechanisms though they are not clearly established. The role of probiotics in improving intestinal permeability has not been evaluated. The probiotic VSL# 3 is easily available, cheap, effective and safe alternative or substitute for the existing therapeutic agents and will be evaluated in this study for their efficacy, tolerability, compliance in inducing clinical response in patients with ulcerative colitis. This will be a double blind randomized placebo controlled study to determine the clinical efficacy of 12 weeks of oral probiotics (VSL#3) in patients with inflammatory bowel disease. The objective of this study are to determine the efficacy of probiotics on clinical endoscopic and histological improvement, to find the improvement in faecal, serum and intestinal tissue inflammatory markers, improvement in intestinal permeability, improvement in quality of life parameters. |