NCT01193894

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2010

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 1, 2010

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2010

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 2, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

December 17, 2013

Status Verified

December 1, 2013

Enrollment Period

2.1 years

First QC Date

August 23, 2010

Last Update Submit

December 16, 2013

Conditions

Ulcerative Colitis

Keywords

IBDUCProferminFresubinProbioticsDietetic

Outcome Measures

Primary Outcomes (1)

  • Development in Simple Clinical Colitis Activity Index (SCCAI) score

    Clinical significant difference (\>1.5) in course of SCCAI score between the two intervention groups

    8 and 16 weeks

Secondary Outcomes (3)

  • Reduction in SCCAI score

    8 and 16 weeks

  • Clinical remission

    8 and 16 weeks

  • Safety - Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    20 weeks

Study Arms (2)

Profermin

EXPERIMENTAL
Other: Profermin

Fresubin

ACTIVE COMPARATOR
Other: Fresubin

Interventions

ProferminOTHER

Medical Food (food for special medical purposes)

Profermin
FresubinOTHER

Medical food (food for special medical purposes)

Fresubin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Stoma or intestinal resections
  • Recent changes in UC medication
  • Treatment with antibiotics
  • Diabetes
  • Celiac disease
  • Lactose malabsorption

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Noreba

Allerød Municipality, Capital Region, 3450, Denmark

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

proferminFresubin

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Hans Israelsen, PhD

    Nordisk Rebalance A/S

    STUDY DIRECTOR

  • Aleksander Krag, MD, PhD

    Hvidovre University Hospital

    PRINCIPAL INVESTIGATOR

  • Flemming Bendtsen, MD, DMSci

    Hvidovre University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2010

First Posted

September 2, 2010

Study Start

August 1, 2010

Primary Completion

September 1, 2012

Study Completion

December 1, 2012

Last Updated

December 17, 2013

Record last verified: 2013-12

Locations

DK(1)