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DAIN Diet for Crohn's Disease (DAIN Trial)

N/A
Recruiting
Led By Ana L Maldonado-Contreras, PhD
Research Sponsored by University of Massachusetts, Worcester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0, 6, 10, 14
Awards & highlights
No Placebo-Only Group

Summary

This trial studies a diet intervention to treat Crohn's disease in Puerto Ricans, based on the IBD-AID™ diet, with traditional foods.

Who is the study for?
This trial is for adults aged 21-65 with mild to moderate Crohn's disease who are willing to significantly change their diet. Participants must have stable medication doses and be able to follow study procedures. Those on high-dose steroids, recent C. difficile colitis, ostomies, or using certain diets or probiotics within the last month cannot join.
What is being tested?
The DAIN dietary intervention is being tested for its effectiveness in treating Crohn's disease symptoms. It adapts the IBD-AID™ by incorporating Puerto Rican food preferences while keeping key anti-inflammatory components intact.
What are the potential side effects?
Since this trial involves a dietary intervention (DAIN), side effects may include changes in digestion such as discomfort or altered bowel habits as participants adjust to new foods.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0, 6, 10, 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0, 6, 10, 14 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Improvement of health-related quality of life
Secondary study objectives
Change of Inflammation
Clinical response and remission
Dietary compliance
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm1: Crohn's disease patients + DAINExperimental Treatment1 Intervention
Participants will have 10 weeks of DAIN intervention (From week 1 to week 10)
Group II: Arm 2: Crohn's disease patients no interventionActive Control1 Intervention
Participants will continue consuming their usual diet, with no intervention

Find a Location

Who is running the clinical trial?

University of Puerto RicoOTHER
67 Previous Clinical Trials
22,135 Total Patients Enrolled
University of Massachusetts, WorcesterLead Sponsor
362 Previous Clinical Trials
992,570 Total Patients Enrolled
The Leona M. and Harry B. Helmsley Charitable TrustOTHER
66 Previous Clinical Trials
99,545 Total Patients Enrolled
Ana L Maldonado-Contreras, PhDPrincipal InvestigatorUniversity of Massachusetts Chan Medical School

Media Library

DAIN (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05627128 — N/A
Crohn's Disease Research Study Groups: Arm1: Crohn's disease patients + DAIN, Arm 2: Crohn's disease patients no intervention
Crohn's Disease Clinical Trial 2023: DAIN Highlights & Side Effects. Trial Name: NCT05627128 — N/A
DAIN (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05627128 — N/A
~31 spots leftby Jul 2025
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