Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
20 participants
INTERVENTIONAL
2024-09-16
2026-02-02
Brief Summary
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Detailed Description
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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 GM composition in adult patients with the IBD subtype Crohn's disease (CD).
An 28 day pilot study in adult CD patients at the Digestive Health Institutes (DHI) of University Hospitals Cleveland Medical Center (UHCMC). table
Participation in this study will last for a maximum of 28 days and will consist of two phases. Phase I (baseline period - 7 days) where all grapes and berries will be removed from the diet, and Phase II (intervention period - 21 days) where participants will be supplemented with 46g/d freeze-dried grape powder consumed as 22.5g packets twice daily. The dose of 46g/day of grape powder is equivalent to 1.5 cups of grapes. Participants will be asked to avoid consumption of all other grapes/berries during phase II. The investigators will compare the before and after changes in gut microbiota composition.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Freeze-dried Grape powder intervention
participants will be supplemented with 46g/d freeze-dried grape powder consumed as 22.5g packets twice daily for 21 days.
Freeze dried grape powder
46g/d freeze-dried grape powder
Interventions
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Freeze dried grape powder
46g/d freeze-dried grape powder
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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California Table Grape Commission
OTHER
Case Western Reserve University
OTHER
Responsible Party
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Principal Investigators
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Abigail Basson, PhD
Role: PRINCIPAL_INVESTIGATOR
Case Western Reserve University
Locations
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University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Countries
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Related Links
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California Table Grape Commission
Other Identifiers
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STUDY20230070
Identifier Type: -
Identifier Source: org_study_id