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Effect of Grapes in Inflammatory Bowel Disease

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ClinicalTrials.gov Identifier: NCT05972694
Recruitment Status : Not yet recruiting
First Posted : August 2, 2023
Last Update Posted : May 3, 2024
Sponsor:
Collaborator:
California Table Grape Commission
Information provided by (Responsible Party):
Abigail Basson, Case Western Reserve University

Tracking Information
First Submitted Date  ICMJE July 24, 2023
First Posted Date  ICMJE August 2, 2023
Last Update Posted Date May 3, 2024
Estimated Study Start Date  ICMJE July 2, 2024
Estimated Primary Completion Date September 2, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2023)		 fecal microbiota composition [ Time Frame: baseline (pre-intervention), immediately after the intervention ]
16S microbiome
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2024)
  • fecal myleoperoxidase (MPO) [ Time Frame: baseline (pre-intervention), immediately after the intervention ]
    fecal marker of inflammation
  • fecal calprotectin [ Time Frame: baseline (pre-intervention), immediately after the intervention ]
    fecal marker of inflammation
  • C-reactive protein (CRP) [ Time Frame: baseline (pre-intervention), immediately after the intervention ]
    blood marker of inflammation
Original Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2023)
  • fecal myleoperoxidase (MPO) [ Time Frame: baseline (pre-intervention), immediately after the intervention ]
  • fecal calprotectin [ Time Frame: baseline (pre-intervention), immediately after the intervention ]
  • Crohns Disease Activity Index [ Time Frame: baseline (pre-intervention), immediately after the intervention ]
  • C-reactive protein (CRP) [ Time Frame: baseline (pre-intervention), immediately after the intervention ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Grapes in Inflammatory Bowel Disease
Official Title  ICMJE The Effect of Grapes in Inflammatory Bowel Disease
Brief 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).
Detailed 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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 21 days. A stool and blood sample will be collected at the start and end of the intervention.
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Crohn Disease
Intervention  ICMJE Dietary Supplement: Freeze dried grape powder
46g/d freeze-dried grape powder
Study Arms  ICMJE Experimental: Freeze-dried Grape powder intervention
participants will be supplemented with 46g/d freeze-dried grape powder consumed as 22.5g packets twice daily for 21 days.
Intervention: Dietary Supplement: Freeze dried grape powder
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 1, 2023)		 20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2, 2025
Estimated Primary Completion Date September 2, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Abigail Basson, PhD 2163276003 abigail.basson@uhhospitals.org
Contact: Megan Luskin 216-368-2440 mluskin@case.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05972694
Other Study ID Numbers  ICMJE STUDY20230070
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Abigail Basson, Case Western Reserve University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Case Western Reserve University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE California Table Grape Commission
Investigators  ICMJE Not Provided
PRS Account Case Western Reserve University
Verification Date May 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP