MedDataX Logo

Role of Healthy Bacteria in Ulcerative Colitis

NCT ID: NCT01479660

Last Updated: 2011-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2014-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ulcerative Colitis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Probiotics ulcerative colitis inflammatory bowel disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

Group Type PLACEBO_COMPARATOR

Control

Intervention Type OTHER

Placebo will be orally administered daily for a period of 12 weeks in high dose and low dose

Probiotic

Group Type EXPERIMENTAL

Probiotic

Intervention Type DRUG

Probiotic Capsules (450 billion CFU) will be orally administered daily for a period of 12 weeks and Probiotic in higher dose of (3600 billion CFU) will be administered daily for a period of 12 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Control

Placebo will be orally administered daily for a period of 12 weeks in high dose and low dose

Intervention Type OTHER

Probiotic

Probiotic Capsules (450 billion CFU) will be orally administered daily for a period of 12 weeks and Probiotic in higher dose of (3600 billion CFU) will be administered daily for a period of 12 weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age between 18 and 65 years
* Active disease at presentation

Exclusion Criteria

* Pregnant or lactating women
* Any patient who has received probiotic in the preceding 4 weeks
* Patient with life threatening cardiac, renal, pulmonary or cardiovascular disease
* Inability to obtain the informed consent
* Severe disease requiring hospitalization / steroids/ anti-cytokine therapy
* Patient taking aspirin and other antiplatelet drugs
* Patient with uncontrolled diabetes
* Patient with Gall stone disease
* Patient currently on antibiotic,NSAIDs or indigenous medicine
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ministry of Science and Technology, India

OTHER_GOV

Sponsor Role collaborator

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Bikash Medhi, MBBS, MD(AIIMS),MAMS,FIMSA

Additional Professor, Department of Pharmacology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bikash Medhi, MD

Role: PRINCIPAL_INVESTIGATOR

Post Graduate Institute of Medical Education and Research, Chandigarh

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Post Graduate Institute of Medical Education and Research

Chandigarh, Chandigarh, India

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

India

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Bikash Medhi, MD

Role: CONTACT

Phone: +91-1722755250

Email: [email protected]

Rakesh Kochhar, MD, DM

Role: CONTACT

Phone: +91-1722756608

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Bikash Medhi, MD

Role: primary

Rakesh Kochhar, MD, DM

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CTRI/2011/08/001944

Identifier Type: REGISTRY

Identifier Source: secondary_id

11/6095 dated 15/03/2011

Identifier Type: -

Identifier Source: org_study_id