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Elemental diet arm for Crohn's Disease

N/A

Waitlist Available

Research Sponsored by Massachusetts General Hospital

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 6 and week 12

Awards & highlights

Study Summary

This trial is testing whether a special diet can help treat Crohn's disease or ulcerative colitis.

Who is the study for?

Adults with active Crohn's Disease or Ulcerative Colitis confirmed by recent colonoscopy can join. They must have a certain level of disease activity and be on stable IBD medication, except for decreasing steroids. Excluded are those with stomas, J pouches, recent bowel surgery, chronic narcotic use for pain, recent antibiotic or enteral diet use, pregnancy/breastfeeding women, celiac disease sufferers.Check my eligibility

What is being tested?

The trial is testing two diets: an elemental diet (enteral nutrition) and the specific carbohydrate diet to see how they affect gut health in Crohn's Disease and Ulcerative Colitis patients over a 6-week period at Massachusetts General Hospital. Participants choose their preferred diet and follow it strictly before returning to normal eating.See study design

What are the potential side effects?

Potential side effects may include changes in digestion like constipation or diarrhea due to dietary adjustments. There might also be nutritional deficiencies if the diets do not meet all vitamin and mineral needs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 6 and week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 6 and week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 6 and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Clinical remission

Secondary outcome measures

Biochemical response - CRP

Biochemical response - fecal calprotectin

Clinical response

Other outcome measures

Change in gut microbiome

Trial Design

2Treatment groups

Active Control

Group I: Elemental diet armActive Control1 Intervention

The partial elemental diet will be sufficient to provide 50% of the daily caloric needs for each patient with the remainder from a standard low-residue diet

Group II: Specific carbohydrate armActive Control1 Intervention

The specific carbohydrate diet will be sufficient to meet 100% of the caloric requirements of the patient.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,928 Previous Clinical Trials

13,198,315 Total Patients Enrolled

Media Library

Elemental diet (Other) Clinical Trial Eligibility Overview. Trial Name: NCT02412553 — N/A

Crohn's Disease Research Study Groups: Elemental diet arm, Specific carbohydrate arm

Crohn's Disease Clinical Trial 2023: Elemental diet Highlights & Side Effects. Trial Name: NCT02412553 — N/A

Elemental diet (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02412553 — N/A

Frequently Asked Questions

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

Does the eligibility criteria for this trial include individuals under 30 years of age?

"Candidates with ages ranging from 18 years old to their ninth decade are encouraged to apply for participation in this study."

Answered by AI

Are there vacancies available for individuals to join this experiment?

"It would appear from the description on clinicaltrials.gov that this medical trial is not presently enrolling participants. The posting for this study was first shared in October 2014, and its information has since been adjusted as recently as April 2022. Unfortunately, it does not have openings at present, but there are 254 other studies actively searching for volunteers."

Answered by AI