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A Crohn's Disease Diet to Reduce Symptoms of Crohn's Disease

Primary Purpose

Crohn's Disease

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Elimination Diet
Dietary Guidelines for Americans
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Elimination Diet, Crohn's disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Johns Hopkins University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Elimination Diet

Dietary Guidelines for Americans

Arm Description

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)

The DASH eating plan is based on 1,600, 2,000, 2,600 and 3,100 calories.

Outcomes

Primary Outcome Measures

CDAI score
Clinical endpoints will be Crohn's disease Activity Index (CDAI) scores (remission < 150; mild = 150-220; moderate = 220-450; severe = 450+),

Secondary Outcome Measures

CRP
C-Reactive Protein (CRP) values (0-0.8 mg/L)
sed rate
sedimentation rate (male: 15-20 mm/hr, female: 20-30 mm/hr)
Quality of Life
Score on short inflammatory bowel disease questionniare (SIBDQ) and Brown's GI Quality of Life measure
Symptom improvement
Score of DISQ

Full Information

First Posted
July 8, 2013
Last Updated
April 4, 2016
Sponsor
Johns Hopkins University
Collaborators
The Broad Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01897090
Brief Title
A Crohn's Disease Diet to Reduce Symptoms of Crohn's Disease
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to recruit
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
Collaborators
The Broad Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Elimination Diet, Crohn's disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Elimination Diet
Arm Type
Experimental
Arm Description
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)
Arm Title
Dietary Guidelines for Americans
Arm Type
Active Comparator
Arm Description
The DASH eating plan is based on 1,600, 2,000, 2,600 and 3,100 calories.
Intervention Type
Other
Intervention Name(s)
Elimination Diet
Intervention Type
Other
Intervention Name(s)
Dietary Guidelines for Americans
Primary Outcome Measure Information:
Title
CDAI score
Description
Clinical endpoints will be Crohn's disease Activity Index (CDAI) scores (remission < 150; mild = 150-220; moderate = 220-450; severe = 450+),
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
CRP
Description
C-Reactive Protein (CRP) values (0-0.8 mg/L)
Time Frame
16 WEEKS
Title
sed rate
Description
sedimentation rate (male: 15-20 mm/hr, female: 20-30 mm/hr)
Time Frame
16 weeks
Title
Quality of Life
Description
Score on short inflammatory bowel disease questionniare (SIBDQ) and Brown's GI Quality of Life measure
Time Frame
16 weeks
Title
Symptom improvement
Description
Score of DISQ
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20350266
Citation
Brown AC, Roy M. Does evidence exist to include dietary therapy in the treatment of Crohn's disease? Expert Rev Gastroenterol Hepatol. 2010 Apr;4(2):191-215. doi: 10.1586/egh.10.11.
Results Reference
background
PubMed Identifier
21651358
Citation
Brown AC, Rampertab SD, Mullin GE. Existing dietary guidelines for Crohn's disease and ulcerative colitis. Expert Rev Gastroenterol Hepatol. 2011 Jun;5(3):411-25. doi: 10.1586/egh.11.29.
Results Reference
background
Links:
URL
http://www.broadfoundation.org/
Description
The Broad Foundation

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A Crohn's Disease Diet to Reduce Symptoms of Crohn's Disease

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