Diet as Essential Therapy (DIET) for Inflammatory Bowel Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Irritable Bowel Syndrome (IBS), Gastrointestinal, Crohns Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/19/2018 |
| Start Date: | January 2017 |
| End Date: | December 2019 |
| Contact: | Timothy L Zisman, MD, MPH |
| Email: | tzisman@medicine.washington.edu |
| Phone: | 206-543-3220 |
Randomized Trial of Diet for Crohn's Disease and Impact on Disease Activity and the Microbiome
Recent data suggest that diet in inflammatory bowel disease (IBD) may lead to both symptom
control and disease remission. Historically certain diets have been recommended for patients
with Crohn's disease during exacerbations despite lack of data supporting efficacy. The
investigators propose to evaluate two such diets by randomizing 32 subjects with mildly to
moderately active Crohn's disease to one of two diets that differ in the amount and type of
carbohydrates and fiber. Subjects will remain on the diet for 8 weeks and will be evaluated
for changes from baseline in inflammatory biomarkers, symptomatic disease activity, and the
microbiome.
control and disease remission. Historically certain diets have been recommended for patients
with Crohn's disease during exacerbations despite lack of data supporting efficacy. The
investigators propose to evaluate two such diets by randomizing 32 subjects with mildly to
moderately active Crohn's disease to one of two diets that differ in the amount and type of
carbohydrates and fiber. Subjects will remain on the diet for 8 weeks and will be evaluated
for changes from baseline in inflammatory biomarkers, symptomatic disease activity, and the
microbiome.
Subjects will be randomized in a 1:1 ratio to receive one of two diets that are thought to be
beneficial for Crohn's disease for a period of 8 weeks.
Initial evaluation will include a clinic visit with physical exam, medication review,
supplemental documentation, and labs. Patients will be asked about their food allergies and
intolerances against a master list of all ingredients used in both diets. Patients will then
be provided with instructions on how to record their baseline dietary intake for two weeks
prior to the intervention diet.
At day 0 patients will begin their study diet. All study meals will be provided to the
subject and an approved snack list for the randomized diet will be provided in a sealed
envelope with their first week of meals.
At the conclusion of intervention patients will be asked to resume their previous diet for 4
weeks and record their dietary intake. Stool and blood will be collected at baseline and at
4, 8, and 12 weeks. At the conclusion of the study patients will be told which diet they were
on and will be provided with dietary consultation by a registered dietitian.
Subjects who withdraw from the study before the 4 week assessment will be asked to provide a
final stool sample at the time of withdrawal. If more than 2 subjects drop out prior to week
4, subject replacement will occur.
beneficial for Crohn's disease for a period of 8 weeks.
Initial evaluation will include a clinic visit with physical exam, medication review,
supplemental documentation, and labs. Patients will be asked about their food allergies and
intolerances against a master list of all ingredients used in both diets. Patients will then
be provided with instructions on how to record their baseline dietary intake for two weeks
prior to the intervention diet.
At day 0 patients will begin their study diet. All study meals will be provided to the
subject and an approved snack list for the randomized diet will be provided in a sealed
envelope with their first week of meals.
At the conclusion of intervention patients will be asked to resume their previous diet for 4
weeks and record their dietary intake. Stool and blood will be collected at baseline and at
4, 8, and 12 weeks. At the conclusion of the study patients will be told which diet they were
on and will be provided with dietary consultation by a registered dietitian.
Subjects who withdraw from the study before the 4 week assessment will be asked to provide a
final stool sample at the time of withdrawal. If more than 2 subjects drop out prior to week
4, subject replacement will occur.
Inclusion Criteria:
- Consentable adults of age 18 or older.
- Diagnosis of Crohn's disease made by a primary gastroenterologist based upon history,
physical exam, laboratory/radiological studies, and endoscopy with biopsy.
- Fecal Calprotectin ≥ 300
- Mild to moderate disease activity based upon a modified Harvey Bradshaw Index score of
5-16.
- On stable medication doses for ≥ 2 months.
Exclusion Criteria:
- Inability/unwillingness to adhere to dietary recommendations.
- Allergy or intolerance to any major component of the diets. Major component defined as
an ingredient which, when left out of intervention diets, may affect study outcomes.
- Allium intolerance
- Exclusively vegetarian diet
- Active intra-abdominal or perianal abscess/fistula
- Symptomatic bowel stricture
- Other serious medical conditions such as neurological, liver, kidney, autoimmune, or
systemic disease
- Use of corticosteroids within 1 month prior to baseline visit
- Tobacco, alcohol, or illicit drug abuse
- Pregnant subjects
- Celiac disease
- Patients already on one of the diets being studied
- C. difficile or other enteric infection (O&P, stool enterics)
- Antibiotic use within 2 months prior to baseline visit
We found this trial at
1
site
1959 NE Pacific St
Seattle, Washington 98195
Seattle, Washington 98195
(206) 598-3300
Phone: 206-543-3220
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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