Effect of Grapes in Inflammatory Bowel Disease

Status Not yet recruiting

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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05972694
Study type	Interventional
Source	Case Western Reserve University
Contact	Abigail Basson, PhD
Phone	2163276003
Email	abigail.basson@uhhospitals.org
Status	Not yet recruiting
Phase	N/A
Start date	July 2, 2024
Completion date	November 2, 2025

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04046913` - The ADDapt Diet in Reducing Crohn's Disease Inflammation	N/A
Recruiting	`NCT05169593` - Prevention of Postoperative Endoscopic Recurrence With Endoscopy-driven Versus Systematic Biological Therapy	Phase 4
Recruiting	`NCT06116604` - Early Bowel Resection for Terminal Ileal Crohn's Disease
Recruiting	`NCT05316584` - A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy	N/A
Recruiting	`NCT05627128` - A Culturally Tailored Dietary Intervention to Treat Crohn's Disease	N/A
Recruiting	`NCT05294107` - Intestinal Organoids	N/A
Withdrawn	`NCT04349449` - ENTYVIO in Bio-naive Patients With Moderate/Severe Crohn's Disease (CD) in Daily Practice
Completed	`NCT05051943` - A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Completed	`NCT03058679` - Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission of Crohn's Disease	N/A
Completed	`NCT02871635` - BI 695501 Versus Humira in Patients With Active Crohn's Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity	Phase 3
Recruiting	`NCT04266600` - Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease	N/A
Recruiting	`NCT04539665` - Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease.	N/A
Recruiting	`NCT03913572` - Treatment of Perianal Disease Using Adipose-derived Stem Cells
Completed	`NCT03606499` - Real-world Effectiveness of Ustekinumab in Participants Suffering From Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) With Extra-intestinal Manifestations or Immune-mediated Inflammatory Diseases
Completed	`NCT03668249` - A Study to Characterize Multidimensional Model to Predict the Course of Crohn's Disease (CD)
Terminated	`NCT04102111` - A Study Evaluating Participants With Moderately to Severely Active Crohn's Disease	Phase 2
Recruiting	`NCT04997733` - Fecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF Withdrawal	Phase 3
Recruiting	`NCT05906576` - Post-marketing Registry Study of Infliximab for Injection in Chinese Pediatric Crohn's Disease Patients	Phase 4
Not yet recruiting	`NCT04502303` - 18F-FDG and 68Ga-FAPI PET/CT in Crohn's Disease	Phase 2
Not yet recruiting	`NCT04398836` - Preoperative Nutrition for Crohn's Disease Patients	Phase 3