NCT01765998

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 11, 2013

Completed
21 days until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

January 11, 2013

Status Verified

January 1, 2013

Enrollment Period

1 year

First QC Date

January 6, 2013

Last Update Submit

January 10, 2013

Conditions

Crohn's Disease

Keywords

Crohn's disease, endothelial progenitor cells, probiotic

Outcome Measures

Primary Outcomes (1)

  • endothelial stem cells

    to study the ability to create endothelial progenitor stem cells following probiotic management compared to placebo group

    one year

Study Arms (2)

Probiotic

EXPERIMENTAL

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.

Drug: Probiotic

placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

ProbioticDRUG

Clinical evaluation according to the Crohn's activity scale

Also known as: Bio 25, powder in HPMC Capsule
Probiotic
PlaceboDRUG
placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baruch Padeh Medical Center

Tiberias, Lower Galilee, 15208, Israel

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

ProbioticsPowders

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesDosage FormsPharmaceutical Preparations

Study Officials

  • Arnon Blum, MD

    Baruch Padeh Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

January 6, 2013

First Posted

January 11, 2013

Study Start

February 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

January 11, 2013

Record last verified: 2013-01

Locations

IL(1)