Crohn's DiseaseNCT02412553
Dietary Therapy and Gut Microbiome in Crohn's Disease and Ulcerative Colitis
A study testing Specific carbohydrate diet and Elemental diet in people with Crohn's Disease, run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Specific carbohydrate diet and Elemental diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
- Conditions
- Crohn's Disease
- Being tested
- Specific carbohydrate diet, Elemental diet
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific carbohydrate dietOther
Elemental dietOther
| Study group | Role | What they receive |
|---|---|---|
| Specific carbohydrate arm | Active comparator | The specific carbohydrate diet will be sufficient to meet 100% of the caloric requirements of the patient. Receives: Other: Specific carbohydrate diet |
| Elemental diet arm | Active comparator | 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 Receives: Other: Elemental diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission
Harvey Bradshaw index < 4 or SCCAI < 3 at week 6
Measured: Week 6
Secondary outcomes (3)
Clinical response
reduction in HBI by 3 or more or SCCAI by 2 or more
Measured: Week 6
Biochemical response - CRP
Change in serum C-reactive protein from baseline
Measured: Week 6
Biochemical response - fecal calprotectin
Change in fecal calprotectin from baseline
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2015 (estimated)
- Study startOct 2014
- Primary completionOct 2026
- Study completionOct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashwin Ananthakrishnan, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02412553
- Sponsor's protocol ID
- 2014P001134
- Status last verified
- Nov 2026
- First submitted
- 6 Apr 2015
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Therapy and Gut Microbiome in Crohn's Disease and Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT02412553
- Acronym / sponsor ID
- 2014P001134
- Conditions
- Crohn's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Oct 2026 (actual)
- Study completion
- Oct 2026 (actual)
- First posted
- 9 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Specific carbohydrate arm | Active comparator | Other: Specific carbohydrate dietThe specific carbohydrate diet will be sufficient to meet 100% of the caloric requirements of the patient. |
| Elemental diet arm | Active comparator | Other: Elemental dietThe 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specific carbohydrate diet | Other | Specific carbohydrate arm |
| Elemental diet | Other | Elemental diet arm |
Primary outcome
Clinical remission
Time frame: Week 6
Harvey Bradshaw index < 4 or SCCAI < 3 at week 6
3 secondary outcomes
Clinical response
Time frame: Week 6
Biochemical response - CRP
Time frame: Week 6
Biochemical response - fecal calprotectin
Time frame: Week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specific carbohydrate diet and Elemental diet in people with Crohn's Disease, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical remission (time frame: Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.