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

NCT01897090 | Withdrawn

• 1 other identifier: NA_00042692
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn's Disease

Keywords

Elimination Diet; Crohn's disease

Outcome Measures

Primary Outcomes (1)

• CDAI score

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

  16 weeks

Secondary Outcomes (4)

• CRP

  16 WEEKS

• sed rate

  16 weeks

• Quality of Life

  16 weeks

• Symptom improvement

  16 weeks

Study Arms (2)

Elimination Diet

EXPERIMENTAL

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)

Other: Elimination Diet

Dietary Guidelines for Americans

ACTIVE COMPARATOR

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

Other: Dietary Guidelines for Americans

Interventions

Elimination Diet OTHER

Elimination Diet

Dietary Guidelines for Americans OTHER

Dietary Guidelines for Americans

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Johns Hopkins University: lead
• The Broad Foundation: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Related Publications (2)

• 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.

  PMID: 20350266 BACKGROUND

• 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.

  PMID: 21651358 BACKGROUND

Related Links

• The Broad Foundation

MeSH Terms

Conditions

Crohn Disease

Interventions

Elimination Diets; Nutrition Policy

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Policy; Public Policy; Social Control Policies; Policy; Health Care Economics and Organizations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: July 8, 2013
• First Posted: July 11, 2013
• Study Start: January 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: April 5, 2016

Record last verified: 2016-04

Locations

US (1)