Role of Healthy Bacteria in Ulcerative Colitis

Status Recruiting

Clinical Trial Summary

Intestinal inflammation seen in inflammatory bowel disease (IBD) results from an altered mucosal immune response to luminal bacterial antigens. Current research suggests that an inappropriate and persistent immune response against commensal intestinal bacterial flora plays a pivotal role in the pathogenesis of chronic Inflammatory Bowel Disease (IBD). It has been also proposed that the signs and symptoms of IBD may be mediated by the increased intestinal permeability secondary to low grade inflammation in the gut mucosa. Increased intestinal permeability results in further exposure of underlying intestinal mucosa to luminal bacteria and antigens perpetuating the intestinal inflammation. Thus restoring intestinal permeability rather than only reduction of mucosal inflammation would thus be a desirable endpoint in the restoration of mucosal integrity and would be the harbinger of better long term outcome. Many clinical trials have shown that probiotics may have beneficial effect on IBD patients. Probiotics are hypothesized to work by several mechanisms though they are not clearly established. The role of probiotics in improving intestinal permeability has not been evaluated. The probiotic VSL #3 is easily available, cheap, effective and safe alternative or substitute for the existing therapeutic agents will be evaluated in this study for their efficacy, tolerability, compliance in inducing clinical response in patients with Ulcerative colitis. This will be a double blind randomized placebo controlled study to determine the clinical efficacy of 12 weeks of oral probiotics (VSL#3) in patients with inflammatory bowel disease. The objectives of this study are to determine the efficacy of probiotics on clinical endoscopic and histological improvement, to find the improvement in faecal, serum and intestinal tissue inflammatory markers, improvement in intestinal permeability, improvement in Quality of life parameters.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01479660
Study type	Interventional
Source	Postgraduate Institute of Medical Education and Research
Contact	Bikash Medhi, MD
Phone	+91-1722755250
Email	drbikashus@yahoo.com
Status	Recruiting
Phase	Phase 4
Start date	March 2011
Completion date	October 2014

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05702879` - Combined Microbiota and Metabolic Signature in Ulcerative Colitis Predicts Anti-Inflammatory Therapy Success
Not yet recruiting	`NCT05953402` - A Study of Ozanimod in Pregnant Women With Ulcerative Colitis and Their Offspring
Recruiting	`NCT05316584` - A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy	N/A
Recruiting	`NCT03950232` - An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis	Phase 3
Completed	`NCT03124121` - Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels	Phase 4
Not yet recruiting	`NCT06100289` - A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease	Phase 3
Withdrawn	`NCT04209556` - A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative Colitis	Phase 2
Terminated	`NCT00061282` - Clotrimazole Enemas for Pouchitis in Children and Adults	Phase 1/Phase 2
Recruiting	`NCT04398550` - SCD vs. Mediterranean Diet Therapy in Ulcerative Colitis	N/A
Recruiting	`NCT04314375` - Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis	Phase 4
Active, not recruiting	`NCT04857112` - Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative Colitis	Phase 2
Completed	`NCT05051943` - A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Active, not recruiting	`NCT04033445` - A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis	Phase 2/Phase 3
Recruiting	`NCT05428345` - A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
Active, not recruiting	`NCT06221995` - Energy Expenditure in Patients With Ulcerative Colitis Undergoing Surgery
Recruiting	`NCT04767984` - Testing Atorvastatin to Lower Colon Cancer Risk in Longstanding Ulcerative Colitis	Phase 2
Completed	`NCT02508012` - Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases	N/A
Recruiting	`NCT06071312` - FMT in Patients With Recurrent CDI and Ulcerative Colitis: Single Infusion Versus Sequential Approach	Phase 1/Phase 2
Completed	`NCT03760003` - Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis	Phase 2
Not yet recruiting	`NCT05539625` - Mini-MARVEL - Mitochondrial Antioxidant Therapy in Ulcerative Colitis	Phase 2