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Completed

NCT Number: NCT01193894

Trial on Profermin and Fresubin in Ulcerative Colitis

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

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Noreba

Allerød Municipality, Capital Region, 3450, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Profermin

Other

Medical Food (food for special medical purposes)

Fresubin

Other

Medical food (food for special medical purposes)

Primary outcomes

  1. Development in Simple Clinical Colitis Activity Index (SCCAI) score

    Time frame: 8 and 16 weeks

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

Secondary outcomes

  1. Reduction in SCCAI score

    Time frame: 8 and 16 weeks

    Proportion of patients with a reduction in SCCAI above 1.5, 3.0 and 4.5

  2. Clinical remission

    Time frame: 8 and 16 weeks

    Proportion of patients in clinical remission (SCCAI=<2.5)

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

    Time frame: 20 weeks

Sponsors and collaborators

Lead sponsor

Nordisk Rebalance A/S

Industry

Collaborators

  • Hvidovre University Hospital

Registry information

Official study title

A Randomized Trial on Profermin and Fresubin for Dietetic Treatment of Active Ulcerative Colitis

Acronym: CUPE2

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Sep 2, 2010
Registry last updated
Dec 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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