MedDataX Logo

Trial on Profermin and Fresubin in Ulcerative Colitis

NCT ID: NCT01193894

Last Updated: 2013-12-17

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study aim to investigate the effect of Profermin versus Fresubin in the dietetic treatment of active ulcerative colitis.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ulcerative Colitis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

IBD UC Profermin Fresubin Probiotics Dietetic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Profermin

Group Type EXPERIMENTAL

Profermin

Intervention Type OTHER

Medical Food (food for special medical purposes)

Fresubin

Group Type ACTIVE_COMPARATOR

Fresubin

Intervention Type OTHER

Medical food (food for special medical purposes)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Profermin

Medical Food (food for special medical purposes)

Intervention Type OTHER

Fresubin

Medical food (food for special medical purposes)

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Active ulcerative colitis (SCCAI =\>5 and \<=11)
* Access to Internet

Exclusion Criteria

* Stoma or intestinal resections
* Recent changes in UC medication
* Treatment with antibiotics
* Diabetes
* Celiac disease
* Lactose malabsorption
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hvidovre University Hospital

OTHER

Sponsor Role collaborator

Nordisk Rebalance A/S

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hans Israelsen, PhD

Role: STUDY_DIRECTOR

Nordisk Rebalance A/S

Aleksander Krag, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hvidovre University Hospital

Flemming Bendtsen, MD, DMSci

Role: STUDY_CHAIR

Hvidovre University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Noreba

Allerød Municipality, Capital Region, Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CUPE2

Identifier Type: -

Identifier Source: org_study_id