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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
DAIN Trial 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.Check my eligibility
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.See study design
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.
DAIN Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 0, 6, 10, 14
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0, 6, 10, 14
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical response and remission
Secondary outcome measures
Change of Inflammation
Dietary compliance
Gut Microbiome changes
DAIN 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 Massachusetts, WorcesterLead Sponsor
345 Previous Clinical Trials
989,297 Total Patients Enrolled
University of Puerto RicoOTHER
62 Previous Clinical Trials
20,680 Total Patients Enrolled
The Leona M. and Harry B. Helmsley Charitable TrustOTHER
57 Previous Clinical Trials
93,736 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I take more than 20mg of prednisone or its equivalent daily.My medication doses have been stable for the required time.I am willing and able to make major changes to my diet.I am between 21 and 65 years old.I recently had a C. difficile infection in my colon.I have had a blockage in my body or symptoms of one in the last 6 months.I have been diagnosed with Crohn's disease and my symptoms are mild to moderate.I have not taken any probiotics in the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Arm1: Crohn's disease patients + DAIN
- Group 2: Arm 2: Crohn's disease patients no intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Do I meet the criteria to take part in this research program?
"The trial is searching for 150 participants, aged 21 to 65 years old, who are suffering from ileocolitis."
Answered by AI
Does the current research include elderly participants?
"The criteria for enrolment in this clinical trial necessitates that patients must be aged between 21 and 65."
Answered by AI
Is recruitment still underway for this clinical investigation?
"According to the data available on clinicaltrials.gov, this study is presently recruiting volunteers and has been since its launch date of September 6th 2022. The most recent update was made on November 15th 2022."
Answered by AI
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