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

Primary Purpose

Crohn's Disease

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Specific carbohydrate diet
Elemental diet
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Specific carbohydrate arm

Elemental diet arm

Arm Description

The specific carbohydrate diet will be sufficient to meet 100% of the caloric requirements of the patient.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Clinical response
reduction in HBI by 3 or more or SCCAI by 2 or more
Biochemical response - CRP
Change in serum C-reactive protein from baseline
Biochemical response - fecal calprotectin
Change in fecal calprotectin from baseline

Full Information

First Posted
April 6, 2015
Last Updated
April 4, 2022
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02412553
Brief Title
Dietary Therapy and Gut Microbiome in Crohn's Disease and Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2014 (undefined)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Specific carbohydrate arm
Arm Type
Active Comparator
Arm Description
The specific carbohydrate diet will be sufficient to meet 100% of the caloric requirements of the patient.
Arm Title
Elemental diet arm
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Specific carbohydrate diet
Intervention Type
Other
Intervention Name(s)
Elemental diet
Primary Outcome Measure Information:
Title
Clinical remission
Description
Harvey Bradshaw index < 4 or SCCAI < 3 at week 6
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
Clinical response
Description
reduction in HBI by 3 or more or SCCAI by 2 or more
Time Frame
Week 6
Title
Biochemical response - CRP
Description
Change in serum C-reactive protein from baseline
Time Frame
Week 6
Title
Biochemical response - fecal calprotectin
Description
Change in fecal calprotectin from baseline
Time Frame
Week 6
Other Pre-specified Outcome Measures:
Title
Change in gut microbiome
Description
Change in fecal microbiome pattern assessed using 16sRNA sequencing and shotgun metagenomic sequencing
Time Frame
Week 6 and Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

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

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