Effect of Grapes in Inflammatory Bowel Disease

Study Overview
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Brief Summary
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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 gut microbiotacomposition in adult patients with the IBD subtype Crohn's disease (CD).

Detailed Description
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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; equivalent to 1.5 cups fresh grapes) alters the gut microbiota (GM) composition in humans with IBD. The investigators will focus on studying IBD patients affected with CD as a proof of principle that could be tested later in other IBD subtype (ulcerative colitis or others specific surgical conditions). 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 8-week 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 56 days and will consist of two phases. Phase I (baseline period - 21-28 days) where all grapes and berries will be removed from the diet, and Phase II (intervention period - 28 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.

Official Title
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The Effect of Grapes in Inflammatory Bowel Disease

Conditions
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Crohn Disease

Intervention / Treatment
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* Dietary Supplement: Freeze dried grape powder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Documented diagnosis of Crohns disease. CD outpatients in remission Harvey Bradshaw-index in remission (<5 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: subjects will continue to consume their usual diet (excluding all grapes/berries) and consume 46g/d freeze-dried grape powder daily (consumed as 22.5g packets twice daily for 28 days. A stool, urine and blood sample will be collected at the start and end of the intervention..
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Freeze-dried Grape powder intervention<br>participants will be supplemented with 46g/d freeze-dried grape powder consumed as 22.5g packets twice daily for 28 days. | Dietary Supplement: Freeze dried grape powder<br>* 46g/d freeze-dried grape powder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fecal microbiota composition | 16S microbiome | baseline (pre-intervention), immediately after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fecal myleoperoxidase (MPO) |  | baseline (pre-intervention), immediately after the intervention | 
| fecal calprotectin |  | baseline (pre-intervention), immediately after the intervention | 
| Crohns Disease Activity Index |  | baseline (pre-intervention), immediately after the intervention | 
| C-reactive protein (CRP) |  | baseline (pre-intervention), immediately after the intervention |