Diet Intervention for Crohn's Disease Patient

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04213729
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Miami
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Maria T Abreu, MD
Principal Investigator Affiliation University of Miami
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn Disease
Arms & Interventions

Arms

Active Comparator: Crohn's Disease (CD) Control Group

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

Experimental: Experimental CD Low Fat Diet (LFD) Group

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

Experimental: Experimental CD LFD + DPS Group

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).

Interventions

Behavioral: - Diet Counseling

Standard of care diet counseling provided at clinic visit 1.

Other: - CD LFD

Daily breakfast, lunch, dinner and snacks LFD catered meals. Meals will have approximately 20% calories from fat, a goal ratio close to 1:1 omega-6/omega-3 fatty acids, and approximately 25-35 grams of fiber per day.

Behavioral: - Dyadic Psychological Support (DPS)

The dyadic psychosocial support (DPS) intervention will be provided for a total of 12 weeks. The 12-week DPS intervention consists of eight sessions (main sessions) and two booster sessions. The intervention will incorporate psychoeducational components that combine didactic and behavioral regulatory procedures to promote healthy diet behavior for self-determined reasons.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Miami, Miami, Florida

Status

Recruiting

Address

University of Miami

Miami, Florida, 33136

Site Contact

Luis Garces, MS, RD/LDN, CNSC

lgarces@med.miami.edu

305-243-6982