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
- Diseases
- Crohn's disease
- 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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Miami Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.