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Diet Intervention for Crohn's Disease Patient

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ClinicalTrials.gov Identifier: NCT04213729
Recruitment Status : Recruiting
First Posted : December 30, 2019
Last Update Posted : November 13, 2020
Sponsor:
Collaborator:
The Leona M. and Harry B. Helmsley Charitable Trust
Information provided by (Responsible Party):
Maria Abreu, University of Miami

Tracking Information
First Submitted Date  ICMJE December 24, 2019
First Posted Date  ICMJE December 30, 2019
Last Update Posted Date November 13, 2020
Actual Study Start Date  ICMJE November 26, 2019
Estimated Primary Completion Date October 14, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 24, 2019)
  • Change in fat intake [ Time Frame: Baseline, 8 weeks ]
    Change in daily fat intake calculated through patient reported diet diary app Nutrihand.
  • Rate of adherence to fat intake [ Time Frame: Week 36 ]
    Adherence to fat intake is measured by the web-based Automated Self-Administered 24-hour diet recall (ASA24).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 24, 2019)
  • Change in clinical symptoms as assessed by Patient Reported Outcomes (PRO2). [ Time Frame: Baseline, Week 8 ]
    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.
  • Change in clinical symptoms as assessed by the Harvey Bradshaw Index (HBI) [ Time Frame: Baseline, Week 8 ]
    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.
  • Change in clinical symptoms as assessed by the Short Crohn's Disease Activity Index (sCDAI). [ Time Frame: Baseline, Week 8 ]
    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.
  • Change in quality of life (QoL) as assessed by the Short Inflammation Bowel Disease Questionnaire (sIBDQ). [ Time Frame: Baseline, Week 8 ]
    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.
  • Change in quality of life (QoL) as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29). [ Time Frame: Baseline, Week 8 ]
    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).
  • Change in the expression of cytokine high-sensitivity C-reactive protein (hsCRP). [ Time Frame: Baseline, Week 8 ]
    Change in the expression of cytokine high-sensitivity C-reactive protein (hsCRP) evaluated in mg/L.
  • Change in the expression of Serum Amyloid A (SAA). [ Time Frame: Baseline, Week 8 ]
    Change in the expression of SAA evaluated in pg/mL.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diet Intervention for Crohn's Disease Patient
Official Title  ICMJE A Holistic Diet Intervention for People With Crohn's Disease
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Crohn Disease
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Diet Counseling
  • 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.
    Intervention: Other: CD LFD
  • 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:
    • Other: CD LFD
    • Behavioral: Dyadic Psychological Support (DPS)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 24, 2019)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 14, 2022
Estimated Primary Completion Date October 14, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Judith Pignac Kobinger, m 305-243-6217 jpignac@med.miami.edu
Contact: Maria A Quintero, MPH 305-243-4717 mquintero2@med.miami.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04213729
Other Study ID Numbers  ICMJE 20190548
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Maria Abreu, University of Miami
Study Sponsor  ICMJE University of Miami
Collaborators  ICMJE The Leona M. and Harry B. Helmsley Charitable Trust
Investigators  ICMJE
Principal Investigator: Maria T Abreu, MD University of Miami
PRS Account University of Miami
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP