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Profermin® in Active Ulcerative Colitis

NCT ID: NCT01245465

Last Updated: 2010-11-23

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-11-30

Brief Summary

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In this study the investigators aim was to investigate the safety and possible efficacy of Profermin® in patients with ulcerative colitis. The investigators also aimed at assessing the usefulness of a new online daily symptom registration system.

Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Profermin

Daily oral intake of a food for special medical purposes (Profermin)

Group Type EXPERIMENTAL

Profermin

Intervention Type OTHER

Medical Food (food for special medical purposes)

Interventions

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Profermin

Medical Food (food for special medical purposes)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hvidovre University Hospital

OTHER

Sponsor Role collaborator

Nordisk Rebalance A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Noreba

Principal Investigators

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Hans Israelsen, PhD

Role: STUDY_DIRECTOR

Nordisk Rebalance A/S

Other Identifiers

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H-B-2008-FSP-20

Identifier Type: -

Identifier Source: org_study_id