A Crohn's Disease Diet to Reduce Symptoms of Crohn's Disease
Public ClinicalTrials.gov record NCT01897090. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
The Relationship of a "Crohn's Disease Diet" in Reducing Symptoms of Crohn's Disease, Improving Quality of Life, and Decreasing Related Health Care Costs.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
A 16-week randomized, pilot study to determine if an elimination diet reduces symptoms of Crohn's disease. Sixty (60) adult patients (18-75 yrs) with a mild or moderate Crohn's Disease Activity Index (CDAI) of 150-450, will be recruited through the GI practices at Johns Hopkins University. Patients agree not to be on any other major treatments, with the exception of consistent/stable doses of 5-aminosalicylate (ASA) drugs/other medications during the course of the study and will obtain their physician's permission.They will be divided into a treatment and standard diet group: thirty (30) patients will be on the "Crohn's Disease Diet" (primarily an "anti-inflammatory diet that is an elimination diet - gluten-free, casein-free based with limited carbohydrate) and thirty (30) patients will be given the Dietary Guideline recommendations and similar dietary counseling attention. To assess the clinical efficacy and tolerance of the trial population, patients will be monitored by two office visits (at 0 and 12 weeks) by visits with the Clinical Research Unit (CRU) registered dietitians (RDs) at 0, 6, 12, and 16 weeks (4 weeks after the end of the study) for blood and dietary data collection. Clinical endpoints will be Crohn's disease Activity Index (CDAI) scores (remission \< 150; mild = 150-220; moderate = 220-450; severe = 450+), C-Reactive Protein (CRP) values (0-0.8 mg/L), sedimentation rate /(male: 15-20 mm/hr, female: 20-30 mm/hr)/, possibly interleukin-6(/normal value: \<10pg/ml)/, Overall Quality of Life (QOL) through the Inflammatory Bowel Disease Questionnaire (IBDQ), Dudley IBD Symptom Questionnaire (DISQ) surveys, and Brown's Gastrointestinal Quality of Life (QOL) Questionnaire, and health care costs measured by a health care cost questionnaire.
Study identification
- NCT ID
- NCT01897090
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- Not listed
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2012
- Primary completion
- Dec 31, 2013
- Completion
- Dec 31, 2013
- Last update posted
- Apr 4, 2016
2013 – 2014
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21287 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01897090, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 4, 2016 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01897090 live on ClinicalTrials.gov.