Diet Intervention for Crohn's Disease Patient

Crohn Disease Clinical Trial

Official title:

A Holistic Diet Intervention for People With Crohn's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04213729
• Other study ID #: 20190548
• Status: Completed
• Phase: N/A
• Start date: November 26, 2019
• Est. completion date: February 20, 2024

Study information

• Verified date: February 2024
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: February 20, 2024
• Est. primary completion date: February 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease

Intervention

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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	The Leona M. and Harry B. Helmsley Charitable Trust

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in fat intake	Change in daily fat intake calculated through patient reported diet diary app Nutrihand.	Baseline, 8 weeks
Primary	Rate of adherence to fat intake	Adherence to fat intake is measured by the web-based Automated Self-Administered 24-hour diet recall (ASA24).	Week 36
Secondary	Change in clinical symptoms as assessed by Patient Reported Outcomes (PRO2).	PRO2 is the sum of the average daily stool frequency and abdominal pain. A weighted total PRO2 score of less than 75 is an indication of remission.	Baseline, Week 8
Secondary	Change in clinical symptoms as assessed by the Harvey Bradshaw Index (HBI)	HBI is a 5-item questionnaire. An HBI score of <5 indicates remission, 5-7 indicates mild disease, 8-16 indicates moderate disease and >16 indicates severe disease.	Baseline, Week 8
Secondary	Change in clinical symptoms as assessed by the Short Crohn's Disease Activity Index (sCDAI).	sCDAI is the sum of the average daily stool frequency, general well-being and abdominal pain. A weighted total sCDAI score of less than 150 indicates remission, 150-219 indicates mild activity, 220-450 indicates moderate activity and > 450 indicates severe activity.	Baseline, Week 8
Secondary	Change in quality of life (QoL) as assessed by the Short Inflammation Bowel Disease Questionnaire (sIBDQ).	sIBDQ is a 10-item shortened version of the original IBDQ assessing QOL with total scores ranging from 1 to 7 with a higher score indicating a better QOL.	Baseline, Week 8
Secondary	Change in quality of life (QoL) as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29).	The PROMIS-29, a generic health-related quality of life survey, assesses each of the 7 PROMIS domains with 4 questions. The questions are ranked on a 5-point Likert Scale. There is also one 11-point rating scale for pain intensity. A score of 50 represents the mean or average of the reference population. A score of 60 means that the person is one standard deviation above the reference population (standard deviation = 10).	Baseline, Week 8
Secondary	Change in the expression of cytokine high-sensitivity C-reactive protein (hsCRP).	Change in the expression of cytokine high-sensitivity C-reactive protein (hsCRP) evaluated in mg/L.	Baseline, Week 8
Secondary	Change in the expression of Serum Amyloid A (SAA).	Change in the expression of SAA evaluated in pg/mL.	Baseline, Week 8