Threonine Requirement in IBD Adults and Healthy Adult Controls

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02423460
• Date of registration: 12/04/2015
• Prospective Registration: Yes
• Primary sponsor: Nestlé
• Public title: Threonine Requirement in IBD Adults and Healthy Adult Controls
• Scientific title: Threonine Requirement in Healthy Adult Subjects and in Patients With Crohn's Disease and With Ulcerative Colitis Using the Indicator Amino Acid Oxidation (IAAO) Methodology
• Date of first enrolment: May 2015
• Target sample size: 86
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02423460
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Canada

Key inclusion & exclusion criteria

Inclusion Criteria (healthy controls):

- Male age 18 - 40 years of age

- Having obtained his (or his legal representative's) written informed consent.

- Normally nourished and without any inter-current illness.

- Absence of an active inflammatory process in the past month.

Exclusion Criteria (healthy controls):

- Subject who cannot be expected to comply with the study procedures.

- Currently participating or having participated in another clinical study during the
last 4 weeks prior to the beginning of this study.

Inclusion Criteria: Crohn's Disease and Ulcerative Colitis

- Male age 18 - 40 years of age

- Having obtained his (or his legal representative's) Written Informed Consent.

- For both conditions, stable disease state and not malnourished per the treating
physician.

- CD: Harvey Bradshaw Index (HBI) = 8, disease location: evidence of ileal and or colon
inflammatory involvement, no known strictures

- UC: Mayo Score = 7 (or Partial Mayo Score =5)

- No tube feeding - Subjects must be treated and followed by the Gastroenterology team
at Mt. Sinai Hospital, Toronto.

Exclusion Criteria: Crohn's Disease and Ulcerative Colitis

- Uncontrolled inflammation which will likely require surgery or escalation of therapy
in the next 4 weeks

- Concomitant treatment:corticosteroids > 20mg/day

- Subject who cannot be expected to comply with the study procedures. - Subjects not
treated and followed by the Gastroenterology team at Mt. Sinai Hospital, Toronto



Age minimum: 18 Years
Age maximum: 40 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Crohn's Disease

Healthy

Intervention(s)

Other: Threonine

Primary Outcome(s)

Threonine requirement in those with Crohn's Disease, ulcerative colitis and in healthy controls determined using the indicator amino acid oxidation method [Time Frame: 2 years]

Secondary ID(s)

1000046356

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Mount Sinai Hospital, Canada

The Hospital for Sick Children