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Active, Not Recruiting

NCT Number: NCT02412553

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Specific carbohydrate diet

Other

Elemental diet

Other

Primary outcomes

  1. Clinical remission

    Time frame: Week 6

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

Secondary outcomes

  1. Clinical response

    Time frame: Week 6

    reduction in HBI by 3 or more or SCCAI by 2 or more

  2. Biochemical response - CRP

    Time frame: Week 6

    Change in serum C-reactive protein from baseline

  3. Biochemical response - fecal calprotectin

    Time frame: Week 6

    Change in fecal calprotectin from baseline

Other outcomes

  1. Change in gut microbiome

    Time frame: Week 6 and Week 12

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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2026
Study completion
2026
First posted
Apr 9, 2015
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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