A Holistic Diet Intervention for People With Crohn's Disease

  • STATUS
    Recruiting
  • End date
    Oct 14, 2023
  • participants needed
    300
  • sponsor
    University of Miami
Updated on 16 October 2022
antibiotic therapy
antibiotics
corticosteroids
methotrexate
prednisone
immunosuppressive agents
mercaptopurine
ulcerative colitis
budesonide
crohn's disease
sulfasalazine
colitis
mesalamine
aminosalicylate
Accepts healthy volunteers

Summary

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.

Details
Condition Crohn Disease
Treatment Diet Counseling, CD LFD, Dyadic Psychological Support (DPS)
Clinical Study IdentifierNCT04213729
SponsorUniversity of Miami
Last Modified on16 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Patients with Ulcerative Colitis and Celiac Disease
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
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
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
Use of Total Parenteral Nutrition at the time of screening and during the study period
Presence of any of the following laboratory abnormalities during screening period or at least <12 weeks; Hemoglobin <8.0g/dl, Albumin <2.8g/dl
Uncooperative behavior or any condition that could make the patient potentially noncompliant to the study procedure
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
Known allergy to tree nuts or peanuts
Pregnant women
Inclusion and Exclusion Criteria for Family-like Member
Inclusion
Male or Female ≥18 and ≤70 years old
Live in the same household and be involved in the patients' daily diet
No antibiotic use or probiotic use within 2 weeks prior to screening
Exclusion Criteria
Patients with Ulcerative Colitis and Celiac Disease
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
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
Use of cyclosporine, mycophenolate mofetil, sirolimus, thalidomide or tacrolimus within 2 months prior to screening
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
Known allergy to tree nuts or peanuts
Pregnant women
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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