Clinical trial NCT04213729: Diet Intervention for Crohn's Disease Patient
Official title: A Holistic Diet Intervention for People With Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crohn Disease
Keywords: Inflammatory bowel disease (IBD)
Diet
CD
IBD
Psychological support
Family member
Low fat, high fiber
Dyadic
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: The Leona M. and Harry B. Helmsley Charitable Trust
First posted: 2019-12-30
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Change in fat intake
timeFrame: Baseline, 8 weeks
measure: Rate of adherence to fat intake
timeFrame: Week 36
Secondary outcomes:
measure: Change in clinical symptoms as assessed by Patient Reported Outcomes (PRO2).
timeFrame: Baseline, Week 8
measure: Change in clinical symptoms as assessed by the Harvey Bradshaw Index (HBI)
timeFrame: Baseline, Week 8
measure: Change in clinical symptoms as assessed by the Short Crohn's Disease Activity Index (sCDAI).
timeFrame: Baseline, Week 8
measure: Change in quality of life (QoL) as assessed by the Short Inflammation Bowel Disease Questionnaire (sIBDQ).
timeFrame: Baseline, Week 8
measure: Change in quality of life (QoL) as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29).
timeFrame: Baseline, Week 8
measure: Change in the expression of cytokine high-sensitivity C-reactive protein (hsCRP).
timeFrame: Baseline, Week 8
measure: Change in the expression of Serum Amyloid A (SAA).
timeFrame: Baseline, Week 8
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Maria T Abreu, MD
role: PRINCIPAL_INVESTIGATOR
References: