Food Supplementation With VSL#3 as a Support to Standard Pharmaceutical Therapy in Ulcerative Colitis
NCT00951548 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144
Last updated 2009-08-04
Summary
This is a double-blind, randomized, placebo controlled study to assess the beneficial effects of food supplementation with VSL#3 as a support to standard pharmaceutical therapy in patients affected by mild to moderate active ulcerative colitis.
Conditions
Interventions
- DIETARY_SUPPLEMENT
-
VSL#3
Probiotic blend of 8 different strains of lactobacilli and bifidobacteria, dosed at 900 billion bacteria/sachet). Dosage regimen is 2 sachets b.i.d. for 8 weeks
- DIETARY_SUPPLEMENT
-
Placebo
Corn Starch. Dosage regimen is 2 sachets b.i.d. for 8 weeks
Sponsors & Collaborators
-
VSL Pharmaceuticals
lead INDUSTRY
Principal Investigators
-
Claudio De Simone, Prof. · VSL Pharmaceuticals
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-10-31
- Completion
- 2008-10-31
Countries
- Italy
Study Locations
More Related Trials
-
Study to Compare Oral PF-06651600, PF-06700841 and Placebo in Subjects With Moderate to Severe Ulcerative Colitis
NCT02958865 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Tolerability, Efficacy and Dose-response of GSK2831781 in Ulcerative Colitis
NCT03893565 ·Status: TERMINATED ·Phase: PHASE2
-
An Investigation of Oral BT051 in Subjects With Moderately to Severely Active Ulcerative Colitis (UC)
NCT05084261 ·Status: COMPLETED ·Phase: PHASE1
-
The Effect of VSL#3 Probiotic Preparation on the Bile Acid Metabolism in Patients With Inflammatory Bowel Disease
NCT01765439 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis
NCT03398148 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis
NCT03945188 ·Status: COMPLETED ·Phase: PHASE3
-
New Tablet Formulation and Dosing Regimen of Balsalazide Disodium in Mildly to Moderately Active Ulcerative Colitis
NCT00269438 ·Status: COMPLETED ·Phase: PHASE3
-
Impact of Additional Treatment With Saccharomyces Boulardii on Quality of Life in Patients With Mild Forms of Ulcerative Colitis and Crohn Disease
NCT03941418 ·Status: UNKNOWN ·Phase: NA
-
A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants With Moderate to Severe Ulcerative Colitis
NCT04613518 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Safety and Effectiveness of JNJ-54781532 in Patients With Moderately to Severely Active Ulcerative Colitis
NCT01959282 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis
NCT06049017 ·Status: COMPLETED ·Phase: PHASE2
-
Nolpitantium Besylate In Patients With Ulcerative Colitis a Double-Blind, Placebo Controlled Efficacy and Safety Study
NCT00232258 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase II Study in Patients With Moderate to Severe Active Ulcerative Colitis.
NCT03675477 ·Status: COMPLETED ·Phase: PHASE2
-
Prediction of Dietary Intervention Efficacy in Mild Ulcerative Colitis Patients Based on Fecal Microbiome Signatures
NCT05579483 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis
NCT02435992 ·Status: COMPLETED ·Phase: PHASE3
-
Determination of the Optimal Treatment Target in Ulcerative Colitis
NCT04259138 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE4
-
A Study to Learn About the Safety, Effects and Pharmacokinetics of Study Medication (PF-07054894) for the Treatment of Ulcerative Colitis
NCT05549323 ·Status: TERMINATED ·Phase: PHASE1
-
Safety and Efficacy of TJ301 IV in Participants With Active Ulcerative Colitis
NCT03235752 ·Status: COMPLETED ·Phase: PHASE2
-
Nicotinamide Riboside in Ulcerative Colitis
NCT05561738 ·Status: RECRUITING ·Phase: NA
-
Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative Colitis
NCT04857112 ·Status: COMPLETED ·Phase: PHASE2
-
Examining the Efficacy of Fecal Microbiota Transplantation (FMT) and Dietary Fiber in Patients With Ulcerative Colitis
NCT03998488 ·Status: COMPLETED ·Phase: PHASE2
-
Balsalazide Disodium vs. Mesalamine in Mildly to Moderately Active Ulcerative Colitis
NCT00408174 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Vedolizumab IV in Chinese Participants With Ulcerative Colitis
NCT03221036 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Efficacy and Safety of SAR339658 in Patients With Moderate to Severe Ulcerative Colitis
NCT01659138 ·Status: TERMINATED ·Phase: PHASE2
-
Efficacy and Safety Study of Apremilast to Treat Active Ulcerative Colitis
NCT02289417 ·Status: COMPLETED ·Phase: PHASE2