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NCT04213729Completed

Diet Intervention for Crohn's Disease Patient

A Holistic Diet Intervention for People With Crohn's Disease

Source: ClinicalTrials.gov · Last updated 29 Feb 2024

Brief summary (registry, in English)

The purpose of this study is to determine the effectiveness of a low-fat, high fiber diet (LFD) containing a minimal proportion of fat to improve gastrointestinal symptoms, quality of life and signs of inflammation in blood and stool.

Status (registry)
Completed
Study type
Interventional
Enrollment
300 (actual)
First submitted
24 Dec 2019
Start date
26 Nov 2019
Primary completion date
20 Feb 2024
Lead sponsor
University of Miami
NCT number
NCT04213729

What you commit to

  • Study type: Interventional
  • Participants enrolled: 300
  • From 26 Nov 2019 to the primary completion date, 20 Feb 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Abdominal abscess, symptomatic Intestinal stricture, patients with altered anatomy: prior total colectomy or proctocolectomy or anticipated colectomy during the study period and presence of ileal pouch or ostomy
  • Use of cyclosporine, mycophenolate mofetil, sirolimus, thalidomide or tacrolimus within 2 months prior to screening
  • Need for prednisone \> 20 mg daily or budesonide \> 9 mg daily at the time of screening. Received intravenous corticosteroids within 2 weeks prior to screening, during screening, or during the study period except as premedication for anti-TNFs
  • No antibiotic use or probiotic use within 2 weeks prior to screening
  • Abdominal abscess, symptomatic Intestinal stricture, patients with altered anatomy: prior total colectomy or proctocolectomy or anticipated colectomy during the study period and presence of ileal pouch or ostomy
  • Use of cyclosporine, mycophenolate mofetil, sirolimus, thalidomide or tacrolimus within 2 months prior to screening

Other illness

  • Patients with Ulcerative Colitis and Celiac Disease
  • Uncooperative behavior or any condition that could make the patient potentially noncompliant to the study procedure
  • Known allergy to tree nuts or peanuts
  • Patients with Ulcerative Colitis and Celiac Disease
  • Known allergy to tree nuts or peanuts

Lab values

  • Other clinically meaningful laboratory abnormalities: pregnancy or lactation, an unstable or uncontrolled medical disorder, colonic dysplasia or adenomas, and malignant neoplasms. Toxic megacolon situations such as Patients with short life expectancy
  • Presence of any of the following laboratory abnormalities during screening period or at least \<12 weeks; Hemoglobin \<8.0g/dl, Albumin \<2.8g/dl.
  • Other clinically meaningful laboratory abnormalities: pregnancy or lactation, an unstable or uncontrolled medical disorder, colonic dysplasia or adenomas, and malignant neoplasms. Toxic megacolon situations such Uncooperative behavior or any condition that could make the patient potentially noncompliant to the study procedures. Patients with short life expectancy

Age

  • Male or Female ≥18 and ≤70 years old

Other

  • Use of Total Parenteral Nutrition at the time of screening and during the study period.
  • Other significant or life-threatening co-morbidities in which low fat/high fiber diet intervention could negatively affect
  • The need for antibiotic use during the study period
  • Pregnant women
    • Inclusion and Exclusion Criteria for Family-like Member
    • Inclusion:
  • Live in the same household and be involved in the patients' daily diet
  • Use of Total Parenteral Nutrition at the time of screening and during the study period.
  • Other significant or life-threatening co-morbidities in which low fat/high fiber diet intervention could negatively affect
  • The need for antibiotic use during the study period
  • Pregnant women

Who the study is looking for

  • Male or Female ≥18 and ≤70 years old and lives with someone that is involved in daily diet
  • Documented diagnosed of Crohn's Disease
  • sCDAI less than 400
  • Patients on oral 5-aminosalicylates, mesalamine or sulfasalazine must be on a stable dose for ≥2 weeks prior to screening
  • Treated with anti-Tumor Necrotic Factors (TNFs) or immunosuppressants (AZA, 6-Mercaptopurine (6-MP), or methotrexate) at screening must have been on a stable dose for ≥4 weeks
  • On steroids can be on no more than prednisone 20 mg daily or budesonide 9 mg daily at the screening. If clinically indicated, tapering of steroids after 4 weeks of intervention may occur. Prednisone may be tapered by no more than 2.5mg/wk and budesonide by no more than 3 mg/wk.
  • No antibiotic use or probiotic use within 2 weeks prior to screening

Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Miami
Coordinator of this site? Confirm its status
MiamiUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.