Impact of grape powder on gut health in Crohn's disease
The Effect of Grapes in Inflammatory Bowel Disease
This study is testing whether eating freeze-dried grape powder for 21 days can improve gut health in adults with Crohn's disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Case Western Reserve University Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT05972694 on ClinicalTrials.gov |
What this trial studies
This pilot intervention study aims to evaluate the effects of freeze-dried grape powder on the gut microbiota composition in adult patients diagnosed with Crohn's disease. Participants will undergo a 28-day program consisting of a 7-day baseline period without grapes and a 21-day intervention period where they will consume 46g of grape powder daily. The study will assess changes in gut microbiota before and after the intervention to determine the potential benefits of grape powder in managing Crohn's disease.
Who should consider this trial
Good fit: Ideal candidates include adult outpatients with a documented diagnosis of Crohn's disease who are in remission.
Not a fit: Patients with conditions such as short bowel syndrome, symptomatic intestinal stricture, or those who are hospitalized may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel dietary intervention to improve gut health in patients with Crohn's disease.
How similar studies have performed: While the specific use of grape powder in Crohn's disease is novel, previous studies have explored dietary interventions in inflammatory bowel diseases with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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 this trial is running
Cleveland, Ohio
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Abigail Basson, PhD — Case Western Reserve University
- Study coordinator: Abigail Basson, PhD
- Email: abigail.raffner@uhhospitals.org
- Phone: 2163276003
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.