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Grapes for Crohn's Disease
N/A
Recruiting
Led By Abigail Basson, PhD
Research Sponsored by Case Western Reserve University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented diagnosis of Crohns disease. CD outpatients in remission
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (pre-intervention), immediately after the intervention
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see how eating grape powder every day affects the gut bacteria in adults with Crohn's disease.
Who is the study for?
This trial is for adults who can consent to participate, are able to take oral nutrition, complete daily surveys, and record their meals. They must have a confirmed diagnosis of Crohn's disease but currently be in remission as indicated by a Harvey Bradshaw index score of less than 5.
What is being tested?
The study tests the effects of consuming freeze-dried grape powder (46g/day) on gut bacteria composition in patients with Crohn's Disease. It aims to see if grapes can influence the condition positively.
What are the potential side effects?
Potential side effects aren't specified for this trial; however, since it involves dietary intervention with grape powder, possible reactions may include gastrointestinal discomfort or allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My Crohn's disease is currently in remission.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (pre-intervention), immediately after the intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (pre-intervention), immediately after the intervention
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
fecal microbiota composition
Secondary study objectives
C-reactive protein (CRP)
fecal calprotectin
fecal myleoperoxidase (MPO)
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: Freeze-dried Grape powder interventionExperimental Treatment1 Intervention
participants will be supplemented with 46g/d freeze-dried grape powder consumed as 22.5g packets twice daily for 21 days.
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Who is running the clinical trial?
Case Western Reserve UniversityLead Sponsor
309 Previous Clinical Trials
251,143 Total Patients Enrolled
California Table Grape CommissionOTHER
7 Previous Clinical Trials
248 Total Patients Enrolled
Abigail Basson, PhDPrincipal InvestigatorCase Western Reserve University
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