Effect of Grapes in Inflammatory Bowel Disease

Completed · Not applicable

Conditions studied: Crohn Disease

In brief

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 microbiotacomposition in adult patients with the IBD subtype Crohn's disease (CD).

Key facts

Study ID

NCT05972694

Run by

Case Western Reserve University

People needed

21

Starts

2024-09-16

Expected to finish

2026-02-15

Last updated by the study team

2026-03-05

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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