| CTRI Number |
CTRI/2008/091/000086 [Registered on: 23/06/2008] |
| Last Modified On: |
26/09/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug
Probiotic |
| Study Design |
Randomized, Crossover Trial |
Public Title of Study
Modification(s)
|
EFFECT OF VSL#3 IN PATIENTS WITH MICROSCOPIC COLITIS |
|
Scientific Title of Study
|
A RANDOMIZED, OPEN LABELLED, CONTROLLED TRIAL OF A PROBIOTIC PREPARATION, VSL#3, FOR ASSESSING CLINICAL AND HISTOLOGICAL RESPONSE IN PATIENTS WITH MICROSCOPIC COLITIS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Vineet Ahuja |
| Designation |
|
| Affiliation |
|
| Address |
Dept. of Gastroenterology and HNU
Ansari Nagar, AIIMS
New Delhi
DELHI
110029
India |
| Phone |
9312437081 |
| Fax |
|
| Email |
vins_ahuja@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Vineet Ahuja |
| Designation |
|
| Affiliation |
AIIMS |
| Address |
Dept. of Gastroenterology and HNU
Ansari Nagar, AIIMS
New Delhi
DELHI
110029
India |
| Phone |
9312437081 |
| Fax |
|
| Email |
vins_ahuja@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Vineet Ahuja |
| Designation |
|
| Affiliation |
|
| Address |
Dept. of Gastroenterology and HNU
Ansari Nagar, AIIMS
New Delhi
DELHI
110029
India |
| Phone |
9312437081 |
| Fax |
|
| Email |
vins_ahuja@hotmail.com |
|
|
Source of Monetary or Material Support
|
| CD Pharma India Pvt. Ltd., C-1/53, First Floor, SDA, New Delhi-110016, Tel.: 0091-11-41759898 |
|
Primary Sponsor
Modification(s)
|
| Name |
CD Pharma India Pvt Ltd |
| Address |
C-1/53, First Floor, SDA, New Delhi-110016, Tel.: 0091-11-41759898 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
Modification(s)
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Vineet Ahuja |
Dept. of Gastroenterology and HNU, AIIMS |
Ansari nagar,-110029
New Delhi
DELHI |
9312437081
vins_ahuja@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS-IEC |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Microscopic colitis (Lymphocytic colitis, collagenous colitis and Not otherwise sepcified colitis/ NOS), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Mesalamine Tabs |
400 mg QD for 8 weeks + 2 weeks wash out + 8 weeks VSL#3, 1 sachet BD. Regular follow ups done and disease assessed at follow ups |
| Intervention |
VSL#3 sachets (450 billion) |
1 sachet BD for 8 weeks and then no medication for further 10 weeks. Follow ups done and disease condition assessed. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age more than or equal to 18 years
2. Collagenous or lymphocytic colitis diagnosed on colon biopsies reviewed by a GI pathologist
3. Currently symptomatic as defined by more than or equal to 3 bowel movements per day with a stool consistency more than 3 and a diarrhea severity score more than 1 averaged over the week prior to enrolment in the study
4. A syndrome present for at least 8 weeks characterized by non-bloody watery diarrhea
5. A normal endoscopic appearance of the colonic mucosa
6. Colonic histopathology (that includes involvement of distal colon) consisting of excess mononuclear inflammatory cells in the lamina propria and surface epithelium without significant neutrophilic or eosinophilic inflammation, numerous crypts abscesses, or granulomata and no other evidence of Crohn?s disease
7. Eligible patients would be included if they had no steatorrhea, had taken no antibiotics or anti-inflammatory agents for at least 6 weeks and no antidiarrheals (e.g., Loperamide) for at least 2 weeks before beginning the study
8. Negative stool culture for pathogens (Salmonella and Shigella), parasites and ova/ cyst
9. For women of child-bearing potential, had a negative pregnancy test
10. Ability to give a valid informed consent. |
|
| ExclusionCriteria |
| Details |
1. Unwilling or unable to give informed consent, follow protocol or to stop all medications used to treat diarrhea or colitis
2. Treatment with immunosuppressive medications or presence of an immunocompromised state
3. Other active diarrheal conditions (sprue, infection, hyperthyroidism)
4. Current infection with enteric pathogen
5. Significant hepatic, renal, endocrine (Diabetes), respiratory, neurological or cardiovascular disease as determined by the principal Investigator
6. Patient requiring hospitalization
7. Pregnancy or lactation
8. Use of any other investigational drug and/or participation in any clinical trial within 3 months of entry to this study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical Remission defined as more than 50% reduction in stool frequency or stool weight. Clinical response defined as significant reduction in stool frequency or stool weight |
8 and 18 wks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Diarrheal Rate, Stool consistency, Abdominal pain, mucus, well being, Histopathology, immunihistochemical iNOS staining |
8 and 18 wks |
|
Target Sample Size
Modification(s)
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
06/03/2006 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is an open label trial to compare the clinical and histological improvement in patients with microscopic colitis on VSL#3 Vs Mesalamine. The duration of treatment will be 8 weeks. Then, thereafter a wash-out period of 2 weeks, patients taking mesalamine will be given VSL#3 for 8 weeks. The patients who were in VSL#3 treatment arm will be off medication and followed up for the next 10 weeks and the diarrheal scores will be noted for relapse. The endpoints would be assessed based on the histological improvement, stool consistency, stool frequency, stool weight, mucus and the QoL score. |