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Role of healthy bacteria in ulcerative colitis.

"A Randomized control trial to study the effect of oral probiotic versus placebo in patients with ulcerative colitis on clinical/endoscopic response intestinal permeability and fecal and serum markers of mucosal inflammation in addition to standard therapy"

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2011/08/001944
Enrollment
72
Registered
2011-08-09
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Active Ulcerative colitis disease

Interventions

Intervention1: VSL#3: VSL# 3(450 billion CFU) will be orally administered daily for a period of 12 weeks Intervention2: VSL#3: VSL#3 (3600 billion CFU) will be administered daily for a period of 12 w

Sponsors

Department of Biotechnology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Active disease at presentation

Exclusion criteria

Exclusion criteria: Patient should not be on antibiotic, NSAIDs or indigenous medicine Pregnant or lactating mother Any patient who received probiotic in the preceding 4 weeks Patient with life threatning cardiac, renal, pulmonary or cardiovascular disease Inability to obtain informed consent Severe disease requiring hospitalization /steroids /anti-cytokine therapy Patient taking antiplatelet drugs Patient with uncontrolled diabetes patient with gall stone disease

Design outcomes

Primary

MeasureTime frame
Response will be defined as reduction of atleast 3 points in the UCDAI from the baseline value at 12 weeks; reduction in the activity score of inflammationTimepoint: 12 weeks

Secondary

MeasureTime frame
Reduction in intestinal permeability Reduction in faecal and serum inflammatory markersTimepoint: 12 weeks

Countries

India

Contacts

Public ContactBikash Medhi

PGIMER

drbikashus@yahoo.com0172-2755250

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026