| CTRI Number |
CTRI/2011/06/001810 [Registered on: 16/06/2011] Trial Registered Prospectively |
| Last Modified On: |
19/12/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic
Other (Specify) [Inflammatory Bowel Disease] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of VSL#3 on the metabolic profile of colonic mucosa in patients with ulcerative colitis in remission using 1H magnetic resonance spectroscopy |
|
Scientific Title of Study
|
A double blind, randomized, placebo controlled trial to investigate the effect of VSL#3 in the metabolic profile of colonic mucosa in patients with ulcerative colitis in remission using 1H magnetic resonance spectroscopy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| VSL#3-MRS-UC-01 dt Apr 13, 2010 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Govind Makharia |
| Designation |
Assoc. Prof. |
| Affiliation |
AIIMS |
| Address |
Dept. of Gastroenterology
Old OT Block
Ist Floor
AIIMS
Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
01126594646 |
| Fax |
01126588091 |
| Email |
govindmakharia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Govind Makharia |
| Designation |
Assoc. Prof. |
| Affiliation |
AIIMS |
| Address |
Dept. of Gastroenterology
Old OT Block
Ist Floor
AIIMS
Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
01126594646 |
| Fax |
01126588091 |
| Email |
govindmakharia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Govind Makharia |
| Designation |
Assoc. Prof. |
| Affiliation |
AIIMS |
| Address |
Dept. of Gastroenterology
Old OT Block
Ist Floor
AIIMS
Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
01126594646 |
| Fax |
01126588091 |
| Email |
govindmakharia@gmail.com |
|
|
Source of Monetary or Material Support
|
| CD Pharma India Pvt. Ltd., C-1/53, First Floor, Safdarjung Development Area, New delhi-110016.
Tel.: 0091-11-41759898, Fax: 0091-11-41759894 |
|
|
Primary Sponsor
|
| 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 = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Govind Makharia |
Dept. of Gastroenterology, AIIMS |
Ansari Nagar
New Delhi
DELHI |
01126594646
01126588091
govindmakharia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients with ulcerative colitis in remission, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo sachets |
1 sachet b.i.d. for 8 weeks |
| Intervention |
VSL#3 Sachets, each sachet containing 900 Billion CFU |
1 sachet b.i.d. for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Males and Females; Age 18 to 80 yrs
2.Male or female patient who is voluntarily able to give informed consent
3.Diagnosis of ulcerative colitis established by previous endoscopy, with consistent histology and clinical course
4.At least one previous episode of colitis
5.Ulcerative colitis Activity: Patients must have a stool frequency score of 0, rectal bleeding score of 0 and mucosal appearance score of 0 or 1 (Ulcerative Colitis Disease Activity Index)
6.Current use of only oral 5-ASA compounds (Only Mesalamine), provided, the dose has been stable at 2400 mgs per day for at least 8 weeks prior to enrolment
7.Ability to give informed consent |
|
| ExclusionCriteria |
| Details |
1.Evidence of abdominal abscess, toxic megacolon, any colectomy, ileostomy, colostomy at the initial screening visit
2.Chronic hepatitis B or C infection, any identified congenital or acquired immunodeficiency (HIV infection, organ transplantation) or any clinically significant extra-intestinal infection (e.g., pneumonia, pyelonephritis) within 30 days prior to enrolment
3.Female patients who are lactating or are known to be pregnant at the time of enrolment
4.Any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise patient safety
5.Had any surgical procedure requiring general anaesthesia within 30 days prior to enrolment or is planning to undergo major surgery during the study period
6.Use of any topical treatment (rectal enemas/ suppositories) prior to 4 weeks of enrolment
7.Use of any probiotics in the last 6 weeks prior to enrolment
8.Use of antibiotics in the past 2 weeks prior to recruitment
9.History/ evidence of or treatment for C. difficile infection within 60 days or other intestinal pathogen within 30 days prior to enrolment
10.History or evidence of colonic mucosal dysplasia
11.Diagnosis of Crohns colitis, pouchitis, proctitis or indeterminate colitis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Difference in metabolic profile in the colonic biopsies of patients with ulcerative colitis before and after 8 weeks of drug administration |
Difference in metabolic profile in the colonic biopsies of patients with ulcerative colitis before and after 8 weeks of drug administration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Difference in metabolic profile in the urine of patients with ulcerative colitis before and after 8 weeks of drug administration |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
01/08/2011 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Suspended |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a double blind, randomized, placebo controlled trial to investigate the effect of VSL#3 in the metabolic profile of colonic mucosa in patients with ulcerative colitis in remission using 1H magnetic resonance spectroscopy. Probiotic, VSL#3, has been found to be effective both in induction and maintenance of UC, improving the clinical symptoms and normalizing the colonic mucosa, as proved from a number of published clinical studies. This study is designed to see if addition of VSL#3 to the conventional regimen acts by improving the metabolic profile (as analyzed by magnetic resonance spectroscopy of the colonic biopsies) of the colonic mucosa in UC remission patients. Research question: Does addition of VSL#3 to mesalamine improve the metabolic profile in the colonic mucosa of ulcerative colitis patients in remission and this forms the primary objective of the study. |