Clinical trial for Crohn Disease
Official title Threonine Requirement in Adult Males With Crohn's Disease Using IAAO
ClinicalTrials.gov ID: NCT04740541
What this study is testing
- What it's testing
- The study aims to find out if people with Crohn's disease need more threonine than healthy young adults. It compares the threonine needs of patients to previous estimates for healthy people.
- Who it's for
- The study is looking for up to 10 adult men with Crohn's disease who are currently stable.
- What's involved
- Participants will follow a specific diet of liquid shakes and protein-free cookies for three days. They will provide urine and breath samples to measure how their body uses threonine.
- Time commitment
- The study involves a 3-hour pre-visit and a 3-day testing period where participants must follow a strict diet and provide samples.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 49, men only
You may be able to join if
- 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 people' ability to consume a normal diet
You likely can't join if
- Uncontrolled inflammation which will likely require surgery or escalation of therapy in the next 4 weeks
- Concomitant treatment: corticosteroid \> 20 mg/day
- people 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
See the full eligibility 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 people' 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
- Uncontrolled inflammation which will likely require surgery or escalation of therapy in the next 4 weeks
- Concomitant treatment: corticosteroid \> 20 mg/day
- people 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
- people 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
The study team makes the final eligibility decision.
Where it is enrolling
- Toronto, Ontario, Canada
Compensation & support
This study's listing mentions compensation or reimbursement.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 49 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Toronto, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.