The Effect of Probiotics on Exacerbation of Inflammatory Bowel Disease Exacerbation (Crohn's Disease)

Baruch Padeh Medical Center

Status and phase: Unknown; Phase 4

Conditions: Crohn's Disease

Treatments: Drug: Placebo; Drug: Probiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT01765998

18-2012.CTIL

Details and patient eligibility

About

Inflammatory Bowel Disease (IBD) is an immune mediated chronic intestinal condition. It includes ulcerative colitis (UC) and Crohn's disease(CD). probiotics have been shown to be effective in varried clinical conditions ranging fron infantile diarrhea, necrotizing enterocolitis,helicobacter pylori infections, etc.

Full description

This is a prospective study that will enroll 50 patients with Crohn's disease.Each patient will get the study medication for 6 weeks and will be evaluated twice- before enrollment and after 6 weeks of treatment.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with Crohns' disease who are stable or have mild acute exacerbations that do not necessitate treatment with systemic corticosteroids

Exclusion criteria

• pregnant women, under 18 years or over 60 years,
• patients with known ulcerative colitis,
• patients with any cancer,
• patients with heart failure

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Probiotic

Experimental group

Description:

To study the effect of probiotic on the ability to build endothelial progenitor stem cells and to study clinical recovery of patients with Crohn's Disease.

Treatment:

Drug: Probiotic

placebo

Placebo Comparator group

Description:

This will be the comparison group to the experimantal group that recives Probiotic.

Treatment:

Drug: Placebo