Diet Intervention for Crohn's Disease Patient

University of Miami

Status: Completed

Conditions: Crohn Disease

Treatments: Behavioral: Dyadic Psychological Support (DPS); Other: CD LFD; Behavioral: Diet Counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT04213729

20190548

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Crohn's disease:

• 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 for Crohn's disease:

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

Crohn's Disease (CD) Control Group

Active Comparator group

Description:

Participants will receive only the one time standard of care in-clinic diet counseling at visit 1.

Treatment:

Behavioral: Diet Counseling

Experimental CD Low Fat Diet (LFD) Group

Experimental group

Description:

Participants will be provided catered LFD meals for 8 consecutive weeks consisting of daily breakfast, lunch, dinner and snacks.

Treatment:

Other: CD LFD

Experimental CD LFD + DPS Group

Experimental group

Description:

Participants and one family member that lives with them will be provided catered LFD meals for 8 consecutive weeks consisting of daily breakfast, lunch, dinner and snacks. In addition, the participant and their family member will receive 12 consecutive weeks of Dyadic Psychological Support (DPS).

Treatment:

Other: CD LFD

Behavioral: Dyadic Psychological Support (DPS)