A Crohn's Disease Diet to Reduce Symptoms of Crohn's Disease
| Status: | Withdrawn |
|---|---|
| Conditions: | Gastrointestinal, Crohns Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/21/2016 |
| Start Date: | January 2013 |
| End Date: | January 2014 |
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.
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.
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.
Inclusion Criteria:
- Between 18 and 75 years of age with any gender.
- Between 150-220 or moderate Crohn's Disease with a CDAI between 220-450.
- Not a smoker.
- No current signs or symptoms of severe, progressive or uncontrolled renal,
gastroenterological, hepatic, hematological, endocrine, pulmonary, cardiac,
neurological or cerebral disease.
- Understand and be able to adhere to the dosing and visit schedules; and agree to
record symptom severity scores, any medications or dietary supplements, and adverse
events accurately and consistently in a daily diary.
- Agree during the study to use only the designated therapy, however, patients will
qualify for the study if they are on a 3-month stable dose of 5-ASA or
immunomodulators and there is a limited change in medication dosage no minimize
biasing the results.
- Agree that you have not previously followed diets where you have eliminated an
allergen, lactose, gluten or major food group for the purpose of reducing Crohn's
disease symptoms within the last year.
- Agree not to use any oral medications, dietary supplements, herbal treatments, diet
therapies within three weeks of the onset of the trial or during the study. During
the study agree to use only the designated therapy, however, patients will qualify
for the study if they are on a 3-month stable dose of 5-aminosalicylic acid (ASA) or
immunomodulators and there is a limited change in medication dosage no minimize
biasing the results.
- Willing to follow the diet during the study and to weigh themselves weekly.
Exclusion Criteria:
- Have extensive colonic, ileal or ileocolonic resection, ileostomies or colostomies
with ileal pouch.
- Experiencing severe weight loss (if % of weight change within 1 week >2% or 1 month
>5% or 3 months >7.5% or 6 months > 10%) or severely malnourished (if < 74% of usual
body weight).
- Pregnant, lactating woman or desire to become pregnant during the study. [ ] [ ]
Patients receiving prescribed oral nutrition and/or intravenous nutrition.
- Presence of alcohol, drug abuse, or smoking (cigarette or other).
We found this trial at
1
site
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
Click here to add this to my saved trials
