Status:
ACTIVE_NOT_RECRUITING
Effect of Grapes in Inflammatory Bowel Disease
Lead Sponsor:
Case Western Reserve University
Collaborating Sponsors:
California Table Grape Commission
Conditions:
Crohn Disease
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The overall objective of this pilot intervention study is to determine the impact of grape powder (46g/day freeze dried whole grape powder provided by the California Table Grape Commission) on the gut...
Detailed Description
This protocol is designed to investigate the effect of grape powder consumption in Inflammatory Bowel Disease (IBD), in particular how grape powder consumption (provided as 46g/day grape powder; equiv...
Eligibility Criteria
Inclusion
- Documented diagnosis of Crohns disease. CD outpatients in remission
- Harvey Bradshaw-index in remission (\<6 score)
- Capable of providing consent to participate.
- Able to complete daily surveys and take oral nutrition
- Able to record daily meal intake
Exclusion
- Short bowel syndrome.
- Hospitalized patients.
- Individuals who lack consent capacity, including the mentally ill, prisoners, cognitively impaired participants, dementia patients.
- Known drug abuse.
- Known parasitic disease of the digestive system.
- Symptomatic intestinal stricture.
- Presence of an ostomy.
- Other conditions that would be a contraindication to consumption of the study diets or preclude the participant from completing the study.
- Well-founded doubt about the patients cooperation.
- Existing pregnancy or lactation.
- History of \<1 natural bowel movements per day.
- Unable to access to technology that permits the daily completion of study related activities.
- Change in IBD medication within past 4 weeks.
- Body mass Index \<16 kg/m or ≥35.
- Documented C.difficile colitis within four weeks of screening.
- Known berry or grape allergy
- No probiotic or antibiotic use for the previous 14 days
Key Trial Info
Start Date :
September 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 2 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05972694
Start Date
September 16 2024
End Date
February 2 2026
Last Update
December 23 2025
Active Locations (1)
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1
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106