Amino acids in j-pouch surgery for ulcerative colitis

Amino acids in ileal pouch-anal anastomosis for ulcerative colitis: a randomized, double-blind placebo-controlled trial - Amino acids in ileal pouch-anal anastomosis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000784-41-DK

Enrollment

Registered

2015-01-28

Start date

2015-04-15

Completion date

Unknown

Last updated

2018-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ileal pouch-anal anastomosis for ulcerative colitis MedDRA version: 18.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856

Interventions

Trade Name: Vaminolac, komb. Product Name: Vaminolac, komb. Pharmaceutical Form: Infusion INN or Proposed INN: Vaminolac, komb. Other descriptive name: Vaminolac, komb. Concentration unit: g/l gram(s)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with ulcerative colitis who are having an ileal pouch-anal anastomosis performed, 18 =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Inability to understand written Danish, postmenopausal women, severe asthma, diabetes mellitus, severe rheumatologic disease, severe comorbidity (ASA group III-IV) in general. Acute or progressing liver failure, uremia without possibility for dialysis, phenylketonuria, defects in amino acid metabolism. Participation in scientific studies in the preceding year, where ionizing radiation has been used, including significant x-ray investigations.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the metabolic effects of intravenous amino acids given during ileal pouch-anal anastomosis surgery for ulcerative colitis.;Secondary Objective: To assess differences in adverse events as a consequence of intravenous administration of amino acids.;Primary end point(s): Differences in palmitate-, tyrosine-, and phenylalanine balances, measured by tracer kinetics.;Timepoint(s) of evaluation of this end point: 3 hours after intervention	—

Measure

Time frame

Main Objective: To investigate the metabolic effects of intravenous amino acids given during ileal pouch-anal anastomosis surgery for ulcerative colitis.;Secondary Objective: To assess differences in adverse events as a consequence of intravenous administration of amino acids.;Primary end point(s): Differences in palmitate-, tyrosine-, and phenylalanine balances, measured by tracer kinetics.;Timepoint(s) of evaluation of this end point: 3 hours after intervention

—

Secondary

Measure	Time frame
Secondary end point(s): Intracellular signalling pathways;Timepoint(s) of evaluation of this end point: 3 hours after intervention	—

Countries

Denmark

Contacts

Public ContactColorectal research unit

Anders Mark Christensen, Department of surgery P, Aarhus University Hospital

amch@clin.au.dk+4578467712

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026