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Low-Fat High-Fiber Diet for Crohn's Disease

N/A
Waitlist Available
Led By Maria T Abreu, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or Female ≥18 and ≤70 years old and lives with someone that is involved in daily diet
Documented diagnosed of Crohn's Disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 36
Awards & highlights

Study Summary

This trial will study whether a low-fat, high-fiber diet can improve symptoms and quality of life in people with gastrointestinal issues.

Who is the study for?
This trial is for adults aged 18-70 with Crohn's Disease who have mild to moderate symptoms (sCDAI <400). They must not have used antibiotics or probiotics within the last two weeks and should be on stable doses of certain medications. Participants need to live with someone involved in their daily diet and can only be on low doses of steroids.Check my eligibility
What is being tested?
The study tests a low-fat, high-fiber diet (LFD) designed to reduce gastrointestinal symptoms and inflammation in Crohn's patients. It includes Dyadic Psychological Support (DPS) and Diet Counseling to help participants adhere to the dietary changes.See study design
What are the potential side effects?
While specific side effects are not listed for this dietary intervention, some individuals may experience changes in digestion or bowel habits as they adjust to the new diet.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 70 years old and live with someone who shares my daily meals.
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I have been diagnosed with Crohn's Disease.
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I have been taking the same dose of my ulcerative colitis medication for at least 2 weeks.
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I have been on a stable dose of TNFs or immunosuppressants for at least 4 weeks.
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I am taking no more than 20 mg of prednisone or 9 mg of budesonide daily.
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I haven't taken antibiotics or probiotics in the last 2 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 36
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 36 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in fat intake
Rate of adherence to fat intake
Secondary outcome measures
Change in clinical symptoms as assessed by Patient Reported Outcomes (PRO2).
Change in clinical symptoms as assessed by the Harvey Bradshaw Index (HBI)
Change in clinical symptoms as assessed by the Short Crohn's Disease Activity Index (sCDAI).
+4 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Experimental CD Low Fat Diet (LFD) GroupExperimental Treatment1 Intervention
Participants will be provided catered LFD meals for 8 consecutive weeks consisting of daily breakfast, lunch, dinner and snacks.
Group II: Experimental CD LFD + DPS GroupExperimental Treatment2 Interventions
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).
Group III: Crohn's Disease (CD) Control GroupActive Control1 Intervention
Participants will receive only the one time standard of care in-clinic diet counseling at visit 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dyadic Psychological Support (DPS)
2019
N/A
~300

Find a Location

Who is running the clinical trial?

The Leona M. and Harry B. Helmsley Charitable TrustOTHER
57 Previous Clinical Trials
93,618 Total Patients Enrolled
University of MiamiLead Sponsor
899 Previous Clinical Trials
409,432 Total Patients Enrolled
Maria T Abreu, MDPrincipal InvestigatorUniversity of Miami
1 Previous Clinical Trials
51 Total Patients Enrolled

Media Library

CD LFD (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04213729 — N/A
Crohn's Disease Research Study Groups: Crohn's Disease (CD) Control Group, Experimental CD Low Fat Diet (LFD) Group, Experimental CD LFD + DPS Group
Crohn's Disease Clinical Trial 2023: CD LFD Highlights & Side Effects. Trial Name: NCT04213729 — N/A
CD LFD (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04213729 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What specific criteria necessitate a person being eligible to enter this research project?

"This medical trial is enrolling 300 participants aged 18-70, who have ileocolitis. In addition to this condition, the patient must meet several other criteria: gender (male or female); live with another person involved in daily diet; documented diagnosis of Crohn's disease; sCDAI less than 400; stable doses of oral 5-aminosalicylates and mesalamine/sulfasalazine for 2 weeks prior to screening; stabilized doses of anti-Tumor Necrotic Factors (TNFs), immunosuppressants such as AZA, 6-Mercaptopurine (6"

Answered by AI

Are there currently any open slots to participate in this medical experiment?

"Affirmative. Clinicaltrials.gov has verified that this medical trial is currently recruiting patients, which was first posted on November 26th 2019 and most recently edited on September 26th 2022. Three hundred participants are being sought from one clinical site."

Answered by AI

What are the major goals of this research endeavor?

"This clinical trial's primary outcome, to be evaluated over a baseline 8 week period, is the Rate of adherence to fat intake. Furthermore, secondary outcomes include changes in Quality of Life (QoL) as assessed by Short Inflammation Bowel Disease Questionnaire (sIBDQ), High-Sensitivity C-Reactive Protein (hsCRP) expression levels measured in mg/L and Clinical Symptom severity graded through the Short Crohn's disease Activity Index (sCDAI)."

Answered by AI

Can individuals aged 60 and above partake in this experimentation?

"This trial requires enrollees to be aged 18 and 70. Separate studies have been conducted for patients below the age of consent (n=69) and those over 65 years old (n=195)."

Answered by AI

How many individuals are presently participating in this research trial?

"Right, clinicaltrials.gov data reveals that the study is currently recruiting participants. It was first listed on November 26th 2019 and its most recent edits were done on September 26th 2022. 300 patients are required to be enrolled at a single site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Diet Intervention for Crohn's Disease Patient
Maria Abreu 2019. "Diet Intervention for Crohn's Disease Patient". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04213729.
~56 spots leftby Apr 2025
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