ACTIVE_NOT_RECRUITING

Effect of Grapes in Inflammatory Bowel Disease

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Conditions

Crohn Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

The Effect of Grapes in Inflammatory Bowel Disease

Quick Facts

Study Start:2024-09-16
Study Completion:2026-02-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05972694

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Documented diagnosis of Crohns disease. CD outpatients in remission
  2. * Harvey Bradshaw-index in remission (\<6 score)
  3. * Capable of providing consent to participate.
  4. * Able to complete daily surveys and take oral nutrition
  5. * Able to record daily meal intake
  1. * Short bowel syndrome.
  2. * Hospitalized patients.
  3. * Individuals who lack consent capacity, including the mentally ill, prisoners, cognitively impaired participants, dementia patients.
  4. * Known drug abuse.
  5. * Known parasitic disease of the digestive system.
  6. * Symptomatic intestinal stricture.
  7. * Presence of an ostomy.
  8. * Other conditions that would be a contraindication to consumption of the study diets or preclude the participant from completing the study.
  9. * Well-founded doubt about the patients cooperation.
  10. * Existing pregnancy or lactation.
  11. * History of \<1 natural bowel movements per day.
  12. * Unable to access to technology that permits the daily completion of study related activities.
  13. * Change in IBD medication within past 4 weeks.
  14. * Body mass Index \<16 kg/m or ≥35.
  15. * Documented C.difficile colitis within four weeks of screening.
  16. * Known berry or grape allergy
  17. * No probiotic or antibiotic use for the previous 14 days

Contacts and Locations

Principal Investigator

Abigail Basson, PhD
PRINCIPAL_INVESTIGATOR
Case Western Reserve University

Study Locations (Sites)

University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States

Collaborators and Investigators

Sponsor: Case Western Reserve University

  • Abigail Basson, PhD, PRINCIPAL_INVESTIGATOR, Case Western Reserve University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-16
Study Completion Date2026-02-02

Study Record Updates

Study Start Date2024-09-16
Study Completion Date2026-02-02

Terms related to this study

Additional Relevant MeSH Terms

  • Crohn Disease