Dietary Therapy and Gut Microbiome in Crohn's Disease and Ulcerative Colitis

This study is currently recruiting participants.

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Contacts and Locations

Verified March 2017 by Ashwin Ananthakrishnan, Massachusetts General Hospital

Sponsor:

Information provided by (Responsible Party):

Ashwin Ananthakrishnan, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT02412553

First received: April 6, 2015

Last updated: March 21, 2017

Last verified: March 2017

History of Changes

Tracking Information

First Received Date ^ICMJE

April 6, 2015

Last Updated Date

March 21, 2017

Start Date ^ICMJE

October 2014

Estimated Primary Completion Date

October 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Clinical remission [ Time Frame: Week 6 ]

Harvey Bradshaw index < 4 or SCCAI < 3 at week 6

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT02412553 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Clinical response [ Time Frame: Week 6 ]
reduction in HBI by 3 or more or SCCAI by 2 or more
Biochemical response - CRP [ Time Frame: Week 6 ]
Change in serum C-reactive protein from baseline
Biochemical response - fecal calprotectin [ Time Frame: Week 6 ]
Change in fecal calprotectin from baseline

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Change in gut microbiome [ Time Frame: Week 6 and Week 12 ]

Change in fecal microbiome pattern assessed using 16sRNA sequencing and shotgun metagenomic sequencing

Original Other Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Dietary Therapy and Gut Microbiome in Crohn's Disease and Ulcerative Colitis

Official Title ^ICMJE

Not Provided

Brief Summary

The study is proposed as a 2-year single site, open-label clinical trial of enteral nutrition or the specific carbohydrate diet in patients with active CD or UC. Patients seeking care in the outpatient clinics of the Division of Gastroenterology at Massachusetts General Hospital will be approached for participation in the trial during their routine outpatient appointments. All patients are required to have a diagnosis of CD or UC confirmed using standard clinical, endoscopic, and histologic criteria. Eligible patients will complete an office visit to confirm eligibility for the study and informed consent will be obtained. They will then be scheduled for a routine colonoscopy as part of their standard clinical care to objectively confirm active disease and obtain biopsies for microbiome and gene expression. The investigators will obtain prior authorization from the subject's insurance company for such colonoscopy, or if it is not covered by the insurance, the investigators will use study funds to pay for the procedure. They will then be assigned to one of two dietary intervention arms based on their preference and will meet with the study registered dietician at the MGH Clinical Research Center (CRC) metabolism and nutrition unit. There, they will receive instruction on the components of the assigned dietary therapy arm - partial elemental diet (enteral nutrition) or specific carbohydrate diet, and will complete a baseline food record (FR). They will adhere to the dietary therapy for 6 weeks after which they can resume normal diet. Clinical, biochemical, nutritional, and microbiological parameters will be measured during and for 6 weeks following the study. They will have 5 study visits during this time.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment

Condition ^ICMJE

Crohn's Disease

Intervention ^ICMJE

Other: Specific carbohydrate diet
Other: Elemental diet

Study Arms

Active Comparator: Specific carbohydrate arm
The specific carbohydrate diet will be sufficient to meet 100% of the caloric requirements of the patient.

Intervention: Other: Specific carbohydrate diet
Active Comparator: Elemental diet arm
The partial elemental diet will be sufficient to provide 50% of the daily caloric needs for each patient with the remainder from a standard low-residue diet

Intervention: Other: Elemental diet

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

October 2018

Estimated Primary Completion Date

October 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

At least 18 years of age
Able to provide written informed consent prior to screening and to comply with the requirements of the study protocol.
Established diagnosis of small bowel or colonic CD or ulcerative colitis
Confirmation of active CD or UC with recent (within 1 month) objective evidence of active disease on colonoscopy
Any medications being currently used for IBD must remain stable during the study period with the exception of tapering of corticosteroids.
Current disease activity defined as a Harvey Bradshaw index > 4 at baseline (week 0) or SCCAI > 3

Exclusion Criteria:

If female, is pregnant or is breast feeding
Known celiac disease or subjects with a positive screen for celiac disease (elevated tissue transglutaminase antibodies)
Inability to provide informed consent or unwilling to participate
Evidence of untreated infection e.g. clostridium difficile
Presence of stoma or J pouch
Presence of enterocutaneous, abdominal or pelvic fistulae with abscesses or fistulae likely to require surgery during the study period
Bowel surgery within 12 weeks prior to screen and/or has surgery planned or deemed likely for IBD during the study period
Fixed symptomatic stenosis of small bowel or colon
Chronic use of narcotics for chronic pain defined as a daily use of one or more doses of narcotic containing medication
Use of oral or intravenous antibiotics within 4 weeks prior to screening
Use of tube or enteral feeding, elemental diet, or parenteral alimentation within 2 weeks prior to screening.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 90 Years (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Ashwin N Ananthakrishnan, MD, MPH	617-726-0267	aananthakrishnan@mgh.harvard.edu
Contact: Christina Y Wong	617-724-7559	cywong4@mgh.harvard.edu

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT02412553

Other Study ID Numbers ^ICMJE

2014P001134

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Ashwin Ananthakrishnan, Massachusetts General Hospital

Study Sponsor ^ICMJE

Massachusetts General Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

PRS Account

Massachusetts General Hospital

Verification Date

March 2017

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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