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Trial record 11 of 179 for:    gastroenterology | Recruiting Studies | United States

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

This study is currently recruiting participants.
See 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
  Purpose
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.

Condition Intervention
Crohn's Disease Other: Specific carbohydrate diet Other: Elemental diet

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

Resource links provided by NLM:


Further study details as provided by Ashwin Ananthakrishnan, Massachusetts General Hospital:

Primary Outcome Measures:
  • Clinical remission [ Time Frame: Week 6 ]
    Harvey Bradshaw index < 4 or SCCAI < 3 at week 6


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • Change in gut microbiome [ Time Frame: Week 6 and Week 12 ]
    Change in fecal microbiome pattern assessed using 16sRNA sequencing and shotgun metagenomic sequencing


Estimated Enrollment: 40
Study Start Date: October 2014
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Specific carbohydrate arm
The specific carbohydrate diet will be sufficient to meet 100% of the caloric requirements of the patient.
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
Other: Elemental diet

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. If female, is pregnant or is breast feeding
  2. Known celiac disease or subjects with a positive screen for celiac disease (elevated tissue transglutaminase antibodies)
  3. Inability to provide informed consent or unwilling to participate
  4. Evidence of untreated infection e.g. clostridium difficile
  5. Presence of stoma or J pouch
  6. Presence of enterocutaneous, abdominal or pelvic fistulae with abscesses or fistulae likely to require surgery during the study period
  7. Bowel surgery within 12 weeks prior to screen and/or has surgery planned or deemed likely for IBD during the study period
  8. Fixed symptomatic stenosis of small bowel or colon
  9. Chronic use of narcotics for chronic pain defined as a daily use of one or more doses of narcotic containing medication
  10. Use of oral or intravenous antibiotics within 4 weeks prior to screening
  11. Use of tube or enteral feeding, elemental diet, or parenteral alimentation within 2 weeks prior to screening.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02412553

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

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
  More Information

Responsible Party: Ashwin Ananthakrishnan, Assistant Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02412553     History of Changes
Other Study ID Numbers: 2014P001134
Study First Received: April 6, 2015
Last Updated: March 21, 2017

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on June 22, 2017