Measuring threonine needs in adult males with Crohn's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to determine the threonine requirement in adult males with Crohn's disease using the Indicator Amino Acid Oxidation (IAAO) method. It will compare the threonine needs of these patients to previously established requirements in healthy young adults. Up to 10 clinically stable patients will be recruited from the IBD Clinic at Mt. Sinai Hospital and followed at The Hospital for Sick Children in Toronto. Participants will undergo a pre-study assessment to evaluate their health metrics before consuming a controlled diet to measure threonine oxidation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male 18 - 49 years of age
* Having obtained his (or his legal representative's) written informed consent
* Evidence of ileal and or colon inflammatory involvement and clinically stable disease state and HBI ≤ 8
* Evidence of some active disease based on history of elevated CRP or parameters of active mucosal
* No evidence of intestinal strictures that may affect the subjects' ability to consume a normal diet
* Have maintained a stable weight for at least 3 months and not on enteral feed via tube
* Willingness to participate in the study and completed the screening procedures (height, weight, fasting blood sample and medical history questionnaire) and willingness to consume the diet provided

Exclusion Criteria:

* Uncontrolled inflammation which will likely require surgery or escalation of therapy in the next 4 weeks
* Concomitant treatment: corticosteroid \> 20 mg/day
* Subjects without any evidence of inflammatory activity
* On medications known to affect protein and amino acid metabolism (steroids)
* Recent significant weight loss
* Individual on weight reducing diets
* Inability to tolerate the diet
* Subjects who cannot be expected to comply with the study procedures
* Significant coffee consumption of more than 2 cups/day
* Significant alcohol consumption of more than one drink/day

Where it's running

• The Hospital for Sick Children
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Glenda Courtney-Martin, PhD, RD — The Hospital for Sick Children
• Study coordinator: Alyssa Paoletti, PhD
• Email: alyssa.paoletti@sickkids.ca
• Phone: 4168137454

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.