Role of Healthy Bacteria in Ulcerative Colitis
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ClinicalTrials.gov Identifier: NCT01479660 |
Recruitment Status
: Unknown
Verified November 2011 by Dr. Bikash Medhi, MBBS, MD(AIIMS),MAMS,FIMSA, Postgraduate Institute of Medical Education and Research.
Recruitment status was: Recruiting
First Posted
: November 24, 2011
Last Update Posted
: November 24, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ulcerative Colitis | Other: Control Drug: Probiotic | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Probiotic for the Restoration of Intestinal Permeability and Reduction of Intestinal Inflammation in Active Ulcerative Colitis: A Double Blind Randomized Placebo Controlled Trial |
Study Start Date : | March 2011 |
Estimated Primary Completion Date : | October 2014 |
Estimated Study Completion Date : | October 2014 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Control |
Other: Control
Placebo will be orally administered daily for a period of 12 weeks in high dose and low dose
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Experimental: Probiotic |
Drug: 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
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- Reduction of at least 3 points in the D.A.I i.e. Reduction in the activity score of inflammation from the baseline value at 12 weeks. [ Time Frame: 12 weeks ]
- Reduction in intestinal permeability [ Time Frame: 12 weeks ]
- Reduction in faecal and serum inflammatory markers [ Time Frame: 12 weeks ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01479660
Contact: Bikash Medhi, MD | +91-1722755250 | drbikashus@yahoo.com | |
Contact: Rakesh Kochhar, MD, DM | +91-1722756608 | dr_kochhar@hotmail.com |
India | |
Post Graduate Institute of Medical Education and Research | Recruiting |
Chandigarh, India, 160012 | |
Contact: Bikash Medhi, MD +91-1722755250 drbikashus@yahoo.com | |
Contact: Rakesh Kochhar, MD, DM +91-1722756608 dr_kochhar@hotmail.com | |
Principal Investigator: Bikash Medhi, MD | |
Sub-Investigator: Rakesh Kochhar, MD,DM | |
Sub-Investigator: Usha Dutta, MD, DM | |
Sub-Investigator: Pallab Ray, MD | |
Sub-Investigator: Kaushal K Prasad, MD | |
Sub-Investigator: Chetana Vaishnavi, Ph.D | |
Sub-Investigator: Kartar Singh, MD, DM |
Principal Investigator: | Bikash Medhi, MD | Post Graduate Institute of Medical Education and Research |
Responsible Party: | Dr. Bikash Medhi, MBBS, MD(AIIMS),MAMS,FIMSA, Additional Professor, Department of Pharmacology, Postgraduate Institute of Medical Education and Research |
ClinicalTrials.gov Identifier: | NCT01479660 History of Changes |
Other Study ID Numbers: |
11/6095 dated 15/03/2011 CTRI/2011/08/001944 ( Registry Identifier: Clinical Trials Registry- India ) |
First Posted: | November 24, 2011 Key Record Dates |
Last Update Posted: | November 24, 2011 |
Last Verified: | November 2011 |
Keywords provided by Dr. Bikash Medhi, MBBS, MD(AIIMS),MAMS,FIMSA, Postgraduate Institute of Medical Education and Research:
Probiotics ulcerative colitis inflammatory bowel disease |
Additional relevant MeSH terms:
Colitis Ulcer Colitis, Ulcerative Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Colonic Diseases Intestinal Diseases Pathologic Processes Inflammatory Bowel Diseases |