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Dietary Therapy and Gut Microbiome in Crohn's Disease and Ulcerative Colitis
NCT02412553 · View on ClinicalTrials.gov ↗
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
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2014-10 |
| Est. Completion | 2026-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02412553
The ClinicalTrials.gov registry entry for NCT02412553 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 1,948 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02412553 reports 1 study location spanning 1 distinct geographic area — top geographies include Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02412553?
The interventions under investigation include: Specific carbohydrate diet (OTHER), Elemental diet (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02412553?
This trial is sponsored by Massachusetts General Hospital, which has 1,948 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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