Effect of Grapes in Inflammatory Bowel Disease

Crohn Disease Clinical Trial

Official title:

The Effect of Grapes in Inflammatory Bowel Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05972694
• Other study ID #: STUDY20230070
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2, 2024
• Est. completion date: November 2, 2025

Study information

• Verified date: May 2024
• Source: Case Western Reserve University
• Contact: Abigail Basson, PhD
• Phone: 2163276003
• Email: abigail.basson[@]uhhospitals.org
• Is FDA regulated: No
• Study type: Interventional

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

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; 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: November 2, 2025
• Est. primary completion date: September 2, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Inflammatory Bowel Diseases

Intervention

Dietary Supplement:
• Freeze dried grape powder
46g/d freeze-dried grape powder

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Case Western Reserve University	California Table Grape Commission

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fecal microbiota composition	16S microbiome	baseline (pre-intervention), immediately after the intervention
Secondary	fecal myleoperoxidase (MPO)	fecal marker of inflammation	baseline (pre-intervention), immediately after the intervention
Secondary	fecal calprotectin	fecal marker of inflammation	baseline (pre-intervention), immediately after the intervention
Secondary	C-reactive protein (CRP)	blood marker of inflammation	baseline (pre-intervention), immediately after the intervention

External Links

•   California Table Grape Commission