| CTRI Number |
CTRI/2008/091/000076 [Registered on: 06/06/2008] |
| Last Modified On: |
25/02/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
A PROBIOTIC PREPARATION, VSL#3, FOR THE TREATMENT OF MILD TO MODERATELY ACTIVE ULCERATIVE COLITIS |
Scientific Title of Study
Modification(s)
|
A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF A PROBIOTIC PREPARATION, VSL#3, FOR THE TREATMENT OF MILD TO MODERATELY ACTIVE ULCERATIVE COLITIS |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| VSL-UC-02 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Rakesh Tandon |
| Designation |
Sr. Consultant |
| Affiliation |
Pushpawati Singhania Research Institute |
| Address |
Dept. of Gastroenterology Pushpawati Singhania Research Institute (PSRI)
Sheikh Sarai
New Delhi
DELHI
110017
India |
| Phone |
9811081338 |
| Fax |
|
| Email |
rakesh_tandon@hotmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Rakesh Tandon |
| Designation |
Sr. Consultant |
| Affiliation |
PSRI, New Delhi |
| Address |
Dept. of Gastroenterology, Pushpawati Singhania Research Institute (PSRI)
Sheikh Sarai
New Delhi
DELHI
110017
India |
| Phone |
9811081338 |
| Fax |
|
| Email |
rakesh_tandon@hotmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Rakesh Tandon |
| Designation |
Sr. Consultant |
| Affiliation |
PSRI |
| Address |
Dept. of Gastroenterology, Pushpawati Singhania Research Institute (PSRI)
Sheikh Sarai
New Delhi
DELHI
110017
India |
| Phone |
9811081338 |
| Fax |
|
| Email |
rakesh_tandon@hotmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| CD Pharma India Pvt. Ltd. |
|
Primary Sponsor
Modification(s)
|
| Name |
CD Pharma India Pvt Ltd |
| Address |
C-1/53, First Floor
Safdarjung Development Area
New Delhi - 110016 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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. Govind Makharia |
Dept of Gastroenterology and HNU |
AIIMS,Ansari Nagar-110029
New Delhi
DELHI |
9868397207
govindmakharia@gmail.com |
| Dr. Ajit Sood |
Dept. of Gastroenterology |
DMC & H,Civil Lines, Tagore Nagar-141001
Ludhiana
PUNJAB |
09914900718
ajitsood10@sify.com |
| Dr. Rakesh Tandon |
Dept. of Gastroenterology |
Pushpawati Singhania Research Institute,Sheikh Sarai-110017
New Delhi
DELHI |
9811081338
rakesh_tandon@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| DMC&H Drug Trial Ethics Committee |
Approved |
| Institute Ethics Committee AIIMS |
Approved |
| PSRI IEC |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Patients with mild to moderately active Ulcerative Colitis, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
VSL#3 |
2 sachets of VSL#3 b.i.d oral for 12 weeks(Each sachet containing 900 billion live bacteria)
|
| Comparator Agent |
VSL#3 Placebo (corn starch) |
2 sachets oral b.i.d. for 12 weeks |
|
Inclusion Criteria
Modification(s)
|
| Age From |
19.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Males and females aged greater than 18 years.
2. Ulcerative colitis extending for more than 15 cm from the anal verge that is involving at least the rectosigmoid. This is based on colonoscopy at any time since the onset of ulcerative colitis. Activity (not extent) must be confirmed by endoscopy at the beginning of the study.
3. Diagnosis of ulcerative colitis established by previous endoscopy, with consistent histology and clinical course.
4. At least one previous episode of colitis, prior to the current episode.
5. Mild to moderately active ulcerative colitis. Patients must have a minimum score of 3 and a maximum score of 8 on the 12 point UCDAI (Ulcerative Colitis Disease Activity Index? see table 1) that measures stool frequency, rectal bleeding, endoscopic findings and physicians overall assessment of disease severity (30-32).
6. Minimum sigmoidoscopic score of 2 on the UCDAI
7. Stool to be taken for culture and microscopy at inclusion. Stools to be assessed by culture for bacterial pathogens (for shigella, salmonella, campylobacter, yersenia), assessed for Cl. Difficile toxin assay, and ova and parasite exam undertaken. This must be checked at the latest by day 7 after entry (preferably at inclusion). Patient must be withdrawn if any of these results is positive (except for E.coli).
8. Negative pregnancy test on screening and agreeing to use valid contraception for the duration of the study.
9. Ability to give a valid informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Crohns disease or pouchitis
2. Current infection with enteric pathogen
3. Use of oral steroids within the last 4 weeks
4. Use of antibiotics within the last two weeks
5. Change in dose of oral 5 ASA products within the last 4 weeks
6. Change in dose of rectal 5-ASA or steroids within 7 days prior to study entry.
7. Significant hepatic, renal, endocrine, respiratory, neurological or cardiovascular disease as determined by the principal Investigator
8. Imminent need for surgery or presence of severe disease (UCDAI of greater than 8)
9. Patient requiring hospitalisation
10. Pregnancy or lactation
11. Use of any other investigational drug and/or participation in any clinical trial within 3 months of entry to this study.
12. Inability to give a valid informed consent or to properly follow the protocol.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • Improvement in activity of active ulcerative colitis. This is defined as a decrease in the UCDAI of 50% or more, from baseline to week 6. |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • Improvement in activity of active ulcerativecolitis. This is defined as a decrease in the UCDAI of 3 points or more, from baseline to week 12. • Remission (defined by a UCDAI score of 0 to 2) after 12 weeks of treatment. • Change in subjective symptoms (rectal bleeding and stool frequency) from baseline to weeks 6 and 12 of treatment. • Lack of improvement at the end of 6 weeks will be considered as treatment failure. Failure to decrease of UCDAI score by 3 points or at least 50% of baseline UCDAI score at the end of 6 weeks will also be considered as treatment failure. • Time to withdrawal.
|
At 6 and 12 weeks |
|
Target Sample Size
Modification(s)
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
15/06/2005 |
| 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
Modification(s)
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Sood A., Midha V., Makharia GK., Ahuja V., Singal D., Goswami P. and Tandon RK.
The probiotic preparation, VSL#3 induces remission in patients with mild-to-moderately active
ulcerative colitis. Clin Gastroenterol Hepatol 11:1202-9 (2009) |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Its a double blind, randomised, placebo controlled trial to assess the safety and efficacy of a probiotic preparation VSL#3 for the treatment of mild to moderate active ulcerative colitis (treated for 12 weeks). Approximately 160 patients with mild to moderately active ulcerative colitis will be entered into this study from 3 centers in India. The primary endpoint is an improvement in activity of active colitis as defined by a decrease in the UCDAI of 50% or more, from baseline to week 6. The secondary endpoints would be to study the improvement in activity of active colitis, as defined by a decrease in the UCDAI of 3 points or more, from baseline to week 12, attainment of remission (defined by a UCDAI score of 0 to 2) after 12 weeks of treatment, Change in individual symptoms (rectal bleeding and stool frequency) from baseline to weeks 6 and 12 of treatment, No. of treatment failures (lack of improvement at the end of 6 weeks will be considered as treatment failure. Failure to decrease of UCDAI score by 3 points or at least 50% of baseline UCDAI score at the end of 6 weeks will also be considered as treatment failure), Time to withdrawal |