Dietary Therapy and Gut Microbiome in Crohn's Disease and Ulcerative Colitis
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal, Crohns Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 8/17/2018 |
| Start Date: | October 2014 |
| End Date: | October 2020 |
| Contact: | Ashwin N Ananthakrishnan, MD, MPH |
| Email: | aananthakrishnan@mgh.harvard.edu |
| Phone: | 617-726-0267 |
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.
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.
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.
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