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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

Must not have

Concomitant treatment: corticosteroid > 20 mg/day

Subjects without any evidence of inflammatory activity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 - 6 months

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am taking more than 20 mg/day of corticosteroids.

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My condition shows no signs of inflammation.

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I am taking steroids that could affect my protein and amino acid levels.

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I have severe inflammation that might need surgery or more intense treatment soon.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 - 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 - 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 - 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Requirement of Threonine in Adult Males with Crohn's Disease

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 8Eligibility criteria met