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Amino Acid
Dietary Intakes for Crohn's Disease
N/A
Recruiting
Led By Glenda Courtney-Martin, PhD, RD
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male 18 - 49 years of age
Evidence of ileal and or colon inflammatory involvement and clinically stable disease state and HBI ≤ 8
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 - 6 months
Awards & highlights
Study Summary
This trial is testing the hypothesis that the threonine requirements of patients with Crohn's disease are higher than previously determined in healthy adults, using the IAAO method. Up to 10 patients will be followed over 3 days, during which they will consume a prescribed diet and have their Phe kinetics measured.
Who is the study for?
This trial is for male adults aged 18-49 with Crohn's Disease showing some active disease signs. They must have stable weight without tube feeding, be able to eat normally despite their condition, and not be on high-dose steroids or other drugs affecting protein metabolism. Heavy drinkers and those who consume a lot of coffee are excluded.Check my eligibility
What is being tested?
The study aims to determine the threonine (an amino acid) requirements in Crohn's patients using a technique called IAAO compared to young healthy adults' needs. Participants will follow a special diet including shakes and cookies for three days while their body's response is monitored through breath and urine samples.See study design
What are the potential side effects?
Potential side effects may include digestive discomfort such as loose or constipated stools due to the dietary changes required by the study protocol. If participants can't tolerate the diet because of taste or digestive issues, they're allowed to withdraw from the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man aged between 18 and 49.
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My bowel condition is stable with mild to moderate symptoms.
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I can eat a normal diet without any blockages in my intestines.
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I have signs of active disease, like high CRP or mucosal issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 - 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 - 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Requirement of Threonine in Adult Males with Crohn's Disease
Trial Design
1Treatment groups
Experimental Treatment
Group I: Threonine Requirement in CD PatientsExperimental Treatment1 Intervention
Males aged 18 - 49 with stable Crohn's disease will be seen for pre-study They will be studied up to 5 times for different levels of threonine intakes.
Find a Location
Who is running the clinical trial?
The Hospital for Sick ChildrenLead Sponsor
690 Previous Clinical Trials
6,945,468 Total Patients Enrolled
MOUNT SINAI HOSPITALOTHER
40 Previous Clinical Trials
14,621 Total Patients Enrolled
Glenda Courtney-Martin, PhD, RDPrincipal InvestigatorThe Hospital for Sick Children
4 Previous Clinical Trials
182 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You drink more than 2 cups of coffee per day.I am a man aged between 18 and 49.My bowel condition is stable with mild to moderate symptoms.I can eat a normal diet without any blockages in my intestines.I am taking more than 20 mg/day of corticosteroids.You drink more than one alcoholic drink per day.I have signs of active disease, like high CRP or mucosal issues.You are currently on a diet to lose weight.You are unable to follow the required diet.My condition shows no signs of inflammation.I am taking steroids that could affect my protein and amino acid levels.I have recently lost a lot of weight without trying.I have severe inflammation that might need surgery or more intense treatment soon.
Research Study Groups:
This trial has the following groups:- Group 1: Threonine Requirement in CD Patients
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is participation in this research restricted to adults?
"The parameters for joining this clinical trial is limited to individuals 18-49 years old. For those younger than the age of consent, there are 74 trials available and 207 studies that cater to elderly participants."
Answered by AI
Are participants being accepted for enrollment in this research endeavor?
"According to clinicaltrials.gov, this study is not presently enrolling patients; however it was initially posted on August 1st 2023 and the latest update was October 24th 2022. Fortunately, there are 270 other trials actively recruiting right now."
Answered by AI
Are there any particular criteria for participation in this clinical experiment?
"Candidates eligible for inclusion in this medical trial must suffer from ileocolitis and fit within the age bracket of 18 to 49. Approximately 10 participants are being sought after by the research team."
Answered by AI
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