| Trial ID: | L0974 |
| Source ID: | CTRI/2008/091/000074
|
| Associated Drug: |
VSL#3
|
| Title: |
Small intestine bacterial overgrowth and role of probiotic, VSL#3 in patients with nonalcoholic fatty liver disease
|
| Acronym: |
--
|
| Status: |
Not Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Health Condition 1: null- Patients with Non alcoholic fatty liver disease
|
| Interventions: |
Intervention1: VSL#3 capsules (112.5 billion per capsule): 2 caps t.i.d. for 1 year<br>Control Intervention1: Placebo capsules: 2 capsules t.i.d. for 1 year<br>(oral)<br>Control Intervention2: Norfloxacin 200 mg capsules: 2 caps b.i.d. for 3 months<br>
|
| Outcome Measures: |
1. To study if small intestine bacterial overgrowth occurs in non diabetic patients with nonalcoholic fatty liver disease. <br/ ><br>2. To study the role of probiotic VSL#3, antibiotic norfloxacin and placebo in achieving biochemical and histological response in patients with nonalcoholic fatty liver disease. <br/ ><br>Timepoint: 1 year treatment period1. To study intestinal transit time in non diabetic patients with nonalcoholic fatty liver disease.<br>2. To study the role of various cytokines, adipokines and endotoxemia and their relation with insulin resistance in patients with nonalcoholic fatty liver disease.<br>Timepoint: 1 year treatment period
|
| Sponsor/Collaborators: |
CD Pharma India Pvt Ltd
|
| Gender: |
--
|
| Age: |
nannan
|
| Phases: |
Phase 2/Phase 3
|
| Enrollment: |
60
|
| Study Type: |
Interventional
|
| Study Designs: |
Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant, Investiga
|
| Start Date: |
09/06/2008
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
24 November 2021
|
| Locations: |
India
|
| URL: |
http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=115
|
