Trial on Profermin and Fresubin in Ulcerative Colitis (CUPE2)

Nordisk Rebalance

Status and phase: Completed; Phase 3; Phase 2

Conditions: Ulcerative Colitis

Treatments: Other: Fresubin; Other: Profermin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01193894

CUPE2

Details and patient eligibility

About

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

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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73 participants in 2 patient groups

Profermin

Experimental group

Treatment:

Other: Profermin

Fresubin

Active Comparator group

Treatment:

Other: Fresubin