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NCT02412553 · ClinicalTrials.gov registry record · NA

Dietary Therapy and Gut Microbiome in Crohn's Disease and Ulcerative Colitis

A NA study of Crohn's Disease, sponsored by Massachusetts General Hospital.

Active
Registry status
NA
Development phase
40
Enrollment target
1
Study location

NCT02412553 is a NA study of Crohn's Disease that is active but no longer recruiting, run by Massachusetts General Hospital. The registered enrollment target is 40 participants, below the 2,394-participant average among 105 other Crohn's Disease trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT02412553, a NA study of Crohn's Disease, is active but no longer recruiting, sponsored by Massachusetts General Hospital.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
40 participants
Enrollment target
1
Study location

Study Summary

The study is proposed as a 2-year single site, open-label clinical trial of enteral nutrition or the specific carbohydrate diet in patients with active CD or UC. Patients seeking care in the outpatient clinics of the Division of Gastroenterology at Massachusetts General Hospital will be approached for participation in the trial during their routine outpatient appointments. All patients are required to have a diagnosis of CD or UC confirmed using standard clinical, endoscopic, and histologic criteria. Eligible patients will complete an office visit to confirm eligibility for the study and informed consent will be obtained. They will then be scheduled for a routine colonoscopy as part of their standard clinical care to objectively confirm active disease and obtain biopsies for microbiome and gene expression. The investigators will obtain prior authorization from the subject's insurance company for such colonoscopy, or if it is not covered by the insurance, the investigators will use study funds to pay for the procedure. They will then be assigned to one of two dietary intervention arms based on their preference and will meet with the study registered dietician at the MGH Clinical Research Center (CRC) metabolism and nutrition unit. There, they will receive instruction on the components of the assigned dietary therapy arm - partial elemental diet (enteral nutrition) or specific carbohydrate diet, and will complete a baseline food record (FR). They will adhere to the dietary therapy for 6 weeks after which they can resume normal diet. Clinical, biochemical, nutritional, and microbiological parameters will be measured during and for 6 weeks following the study. They will have 5 study visits during this time.

Conditions Studied

Interventions

  • OTHER Specific carbohydrate diet
  • OTHER Elemental diet

Study Locations (1)

Massachusetts

  • Massachusetts General Hospital - Boston

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2014-10
Est. Completion 2026-10
Phase NA

Sponsor

Massachusetts General Hospital

2,032 total trials

What the Registry Record Tells You About NCT02412553

The ClinicalTrials.gov registry entry for NCT02412553 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,394-participant average among 105 other Crohn's Disease trials with a reported enrollment target (98% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Crohn's Disease appearing as the primary indexed condition, and to 2 interventions - of which Specific carbohydrate diet is the first listed.

NCT02412553 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.

Frequently Asked Questions

What is clinical trial NCT02412553 about?

NCT02412553 is a clinical study titled "Dietary Therapy and Gut Microbiome in Crohn's Disease and Ulcerative Colitis". The study is proposed as a 2-year single site, open-label clinical trial of enteral nutrition or the specific carbohydrate diet in patients with active CD or UC. Patients seeking care in the outpatient clinics of the Division of Gastroenterology at Massachusetts General Hospital will be approached f...

What is the current status of trial NCT02412553?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2014-10. Estimated completion is 2026-10.

What conditions does trial NCT02412553 study?

This clinical trial studies the following conditions: Crohn's Disease.

What interventions are being tested in trial NCT02412553?

The interventions under investigation include: Specific carbohydrate diet (OTHER), Elemental diet (OTHER).

Who is sponsoring clinical trial NCT02412553?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02412553 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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