Diet as Essential Therapy (DIET) for Inflammatory Bowel Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03012542
• Date of registration: 04/01/2017
• Prospective Registration: No
• Primary sponsor: University of Washington
• Public title: Diet as Essential Therapy (DIET) for Inflammatory Bowel Disease
• Scientific title: Randomized Trial of Diet for Crohn's Disease and Impact on Disease Activity and the Microbiome
• Date of first enrolment: January 2017
• Target sample size: 32
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT03012542
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Timothy L Zisman, MD, MPH
• Affiliation: University of Washington

• Name: Andrea Martin

• Name: Timothy L Zisman, MD, MPH

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Crohn Disease

Intervention(s)

Dietary Supplement: Diet 1

Dietary Supplement: Diet 2

Primary Outcome(s)

Fecal Calprotectin Remission [Time Frame: 8 weeks]

Secondary Outcome(s)

Microbiota correlation with clinical disease activity and inflammatory biomarkers [Time Frame: 8 weeks]

Metagenomics [Time Frame: 8 weeks]

Clinical Response [Time Frame: 8 weeks]

Fecal Calprotectin Response [Time Frame: 8 weeks]

Future Use [Time Frame: 8 weeks]

Secondary ID(s)

STUDY00003247

Source(s) of Monetary Support

Please refer to primary and secondary sponsors