Crohn DiseaseNCT03012542
Diet as Essential Therapy (DIET) for Inflammatory Bowel Disease
A study testing Diet 1 and Diet 2 in people with Crohn Disease, run by University of Washington at 1 site in United States.
Trial summary
Recent data suggest that diet in inflammatory bowel disease (IBD) may lead to both symptom control and disease remission. Historically certain diets have been recommended for patients with Crohn's disease during exacerbations despite lack of data supporting efficacy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Diet 1 and Diet 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Dec 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consentable adults of age 18 or older.
- Diagnosis of Crohn's disease made by a primary gastroenterologist based upon history, physical exam, laboratory/radiological studies, and endoscopy with biopsy.
- Fecal Calprotectin ≥ 300
- Mild to moderate disease activity based upon a modified Harvey Bradshaw Index score of 5-16.
- On stable medication doses for ≥ 2 months.
Who cannot join
- Inability/unwillingness to adhere to dietary recommendations.
- Allergy or intolerance to any major component of the diets. Major component defined as an ingredient which, when left out of intervention diets, may affect study outcomes.
- Allium intolerance
- Exclusively vegetarian diet
- Active intra-abdominal or perianal abscess/fistula
- Symptomatic bowel stricture
Show all 14Show fewer
- Other serious medical conditions such as neurological, liver, kidney, autoimmune, or systemic disease
- Use of corticosteroids within 1 month prior to baseline visit
- Tobacco, alcohol, or illicit drug abuse
- Pregnant subjects
- Celiac disease
- Patients already on one of the diets being studied
- C. difficile or other enteric infection (O\&P, stool enterics)
- Antibiotic use within 2 months prior to baseline visit
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Washington Medical Center
Seattle, Washington, 98195
Andrea Martin, 206-543-3220, amartin@medicine.washington.edu
About this study
Official title: Randomized Trial of Diet for Crohn's Disease and Impact on Disease Activity and the Microbiome
Recent data suggest that diet in inflammatory bowel disease (IBD) may lead to both symptom control and disease remission. Historically certain diets have been recommended for patients with Crohn's disease during exacerbations despite lack of data supporting efficacy. The investigators propose to evaluate two such diets by randomizing 32 subjects with mildly to moderately active Crohn's disease to one of two diets that differ in the amount and type of carbohydrates and fiber. Subjects will remain on the diet for 8 weeks and will be evaluated for changes from baseline in inflammatory biomarkers, symptomatic disease activity, and the microbiome.
Read the detailed description
Subjects will be randomized in a 1:1 ratio to receive one of two diets that are thought to be beneficial for Crohn's disease for a period of 8 weeks.
Initial evaluation will include a clinic visit with physical exam, medication review, supplemental documentation, and labs. Patients will be asked about their food allergies and intolerances against a master list of all ingredients used in both diets. Patients will then be provided with instructions on how to record their baseline dietary intake for two weeks prior to the intervention diet.
At day 0 patients will begin their study diet. All study meals will be provided to the subject and an approved snack list for the randomized diet will be provided in a sealed envelope with their first week of meals.
At the conclusion of intervention patients will be asked to resume their previous diet for 4 weeks and record their dietary intake. Stool and blood will be collected at baseline and at 4, 8, and 12 weeks. At the conclusion of the study patients will be told which diet they were on and will be provided with dietary consultation by a registered dietitian.
Subjects who withdraw from the study before the 4 week assessment will be asked to provide a final stool sample at the time of withdrawal. If more than 2 subjects drop out prior to week 4, subject replacement will occur.
- Conditions
- Crohn Disease
- Being tested
- Diet 1, Diet 2
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet 1Dietary supplement
Diet controlled in amount and source of carbohydrates or fiber containing foods.
Diet 2Dietary supplement
Diet controlled in amount and source of carbohydrates or fiber containing foods.
| Study group | Role | What they receive |
|---|---|---|
| Diet 1 | Experimental | Administered for 8 weeks. Receives: Dietary Supplement: Diet 1 |
| Diet 2 | Experimental | Administered for 8 weeks. Receives: Dietary Supplement: Diet 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal Calprotectin Remission
To compare the proportion of patients with calprotectin remission (fecal calprotectin level < 250 and a decrease by ≥ 100 points) at 8 weeks post-dietary intervention for subjects on each diet
Measured: 8 weeks
Secondary outcomes (5)
Fecal Calprotectin Response
Calprotectin response (decrease by ≥ 100 points) or calprotectin improvement (decrease by > 50%) at weeks 4 and 8 for subjects on each diet. Comparison of the mean calprotectin between the 2 treatment groups.
Measured: 8 weeks
Clinical Response
Proportion of patients on each diet with clinical response (HBI score decrease by ≥ 3) or remission (HBI score < 5) at weeks 4 and 8
Measured: 8 weeks
Metagenomics
To compare changes in the metagenomics of the fecal microbiome at 8 weeks relative to baseline for each diet
Measured: 8 weeks
Microbiota correlation with clinical disease activity and inflammatory biomarkers
To determine if changes in the microbiota are associated with changes in clinical disease activity (HBI score), or inflammatory biomarkers (fecal calprotectin, C-reactive protein, etc.).
Measured: 8 weeks
Future Use
To collect stool and blood for potential future analysis looking at proteomics and metabolomics.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionSep 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy Zisman, University of Washington
- Investigators
- Timothy L Zisman, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03012542
- Sponsor's protocol ID
- STUDY00003247
- Status last verified
- May 2018
- First submitted
- 4 Jan 2017
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Requests from investigators will be evaluated on a case by case basis. Data that may be shared include lab values, patient reported outcomes, questionnaires, and microbiome sequences. Specimens may also be shared. Researchers can request data from the study's Principal Investigator in writing.
Publications
Hou JK, Abraham B, El-Serag H. Dietary intake and risk of developing inflammatory bowel disease: a systematic review of the literature. Am J Gastroenterol. 2011 Apr;106(4):563-73. doi: 10.1038/ajg.2011.44.
PubMed 21468064Richman E, Rhodes JM. Review article: evidence-based dietary advice for patients with inflammatory bowel disease. Aliment Pharmacol Ther. 2013 Nov;38(10):1156-71. doi: 10.1111/apt.12500. Epub 2013 Sep 17.
PubMed 24102340Wu GD, Chen J, Hoffmann C, Bittinger K, Chen YY, Keilbaugh SA, Bewtra M, Knights D, Walters WA, Knight R, Sinha R, Gilroy E, Gupta K, Baldassano R, Nessel L, Li H, Bushman FD, Lewis JD. Linking long-term dietary patterns with gut microbial enterotypes. Science. 2011 Oct 7;334(6052):105-8. doi: 10.1126/science.1208344. Epub 2011 Sep 1.
PubMed 21885731David LA, Maurice CF, Carmody RN, Gootenberg DB, Button JE, Wolfe BE, Ling AV, Devlin AS, Varma Y, Fischbach MA, Biddinger SB, Dutton RJ, Turnbaugh PJ. Diet rapidly and reproducibly alters the human gut microbiome. Nature. 2014 Jan 23;505(7484):559-63. doi: 10.1038/nature12820. Epub 2013 Dec 11.
PubMed 24336217Manichanh C, Borruel N, Casellas F, Guarner F. The gut microbiota in IBD. Nat Rev Gastroenterol Hepatol. 2012 Oct;9(10):599-608. doi: 10.1038/nrgastro.2012.152. Epub 2012 Aug 21.
PubMed 22907164
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Diet for Crohn's Disease and Impact on Disease Activity and the Microbiome
- ClinicalTrials.gov ID
- NCT03012542
- Acronym / sponsor ID
- STUDY00003247
- Conditions
- Crohn Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 6 Jan 2017 (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.
Recent data suggest that diet in inflammatory bowel disease (IBD) may lead to both symptom control and disease remission. Historically certain diets have been recommended for patients with Crohn's disease during exacerbations despite lack of data supporting efficacy. The investigators propose to evaluate two such diets by randomizing 32 subjects with mildly to moderately active Crohn's disease to one of two diets that differ in the amount and type of carbohydrates and fiber. Subjects will remain on the diet for 8 weeks and will be evaluated for changes from baseline in inflammatory biomarkers, symptomatic disease activity, and the microbiome.
Detailed description
Subjects will be randomized in a 1:1 ratio to receive one of two diets that are thought to be beneficial for Crohn's disease for a period of 8 weeks.
Initial evaluation will include a clinic visit with physical exam, medication review, supplemental documentation, and labs. Patients will be asked about their food allergies and intolerances against a master list of all ingredients used in both diets. Patients will then be provided with instructions on how to record their baseline dietary intake for two weeks prior to the intervention diet.
At day 0 patients will begin their study diet. All study meals will be provided to the subject and an approved snack list for the randomized diet will be provided in a sealed envelope with their first week of meals.
At the conclusion of intervention patients will be asked to resume their previous diet for 4 weeks and record their dietary intake. Stool and blood will be collected at baseline and at 4, 8, and 12 weeks. At the conclusion of the study patients will be told which diet they were on and will be provided with dietary consultation by a registered dietitian.
Subjects who withdraw from the study before the 4 week assessment will be asked to provide a final stool sample at the time of withdrawal. If more than 2 subjects drop out prior to week 4, subject replacement will occur.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet 1 | Experimental | Dietary Supplement: Diet 1Administered for 8 weeks. |
| Diet 2 | Experimental | Dietary Supplement: Diet 2Administered for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Consentable adults of age 18 or older.
- Diagnosis of Crohn's disease made by a primary gastroenterologist based upon history, physical exam, laboratory/radiological studies, and endoscopy with biopsy.
- Fecal Calprotectin ≥ 300
- Mild to moderate disease activity based upon a modified Harvey Bradshaw Index score of 5-16.
- On stable medication doses for ≥ 2 months.
Key exclusion criteria (14 listed)
- Inability/unwillingness to adhere to dietary recommendations.
- Allergy or intolerance to any major component of the diets. Major component defined as an ingredient which, when left out of intervention diets, may affect study outcomes.
- Allium intolerance
- Exclusively vegetarian diet
- Active intra-abdominal or perianal abscess/fistula
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 |
|---|---|---|
| Diet 1Diet controlled in amount and source of carbohydrates or fiber containing foods. | Dietary supplement | Diet 1 |
| Diet 2Diet controlled in amount and source of carbohydrates or fiber containing foods. | Dietary supplement | Diet 2 |
Primary outcome
Fecal Calprotectin Remission
Time frame: 8 weeks
To compare the proportion of patients with calprotectin remission (fecal calprotectin level < 250 and a decrease by ≥ 100 points) at 8 weeks post-dietary intervention for subjects on each diet
5 secondary outcomes
Fecal Calprotectin Response
Time frame: 8 weeks
Clinical Response
Time frame: 8 weeks
Metagenomics
Time frame: 8 weeks
Microbiota correlation with clinical disease activity and inflammatory biomarkers
Time frame: 8 weeks
Future Use
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2018.
- Background: PubMed 21468064Hou JK, Abraham B, El-Serag H. Dietary intake and risk of developing inflammatory bowel disease: a systematic review of the literature. Am J Gastroenterol. 2011 Apr;106(4):563-73. doi: 10.1038/ajg.2011.44.
- Background: PubMed 24102340Richman E, Rhodes JM. Review article: evidence-based dietary advice for patients with inflammatory bowel disease. Aliment Pharmacol Ther. 2013 Nov;38(10):1156-71. doi: 10.1111/apt.12500. Epub 2013 Sep 17.
- Background: PubMed 21885731Wu GD, Chen J, Hoffmann C, Bittinger K, Chen YY, Keilbaugh SA, Bewtra M, Knights D, Walters WA, Knight R, Sinha R, Gilroy E, Gupta K, Baldassano R, Nessel L, Li H, Bushman FD, Lewis JD. Linking long-term dietary patterns with gut microbial enterotypes. Science. 2011 Oct 7;334(6052):105-8. doi: 10.1126/science.1208344. Epub 2011 Sep 1.
- Background: PubMed 24336217David LA, Maurice CF, Carmody RN, Gootenberg DB, Button JE, Wolfe BE, Ling AV, Devlin AS, Varma Y, Fischbach MA, Biddinger SB, Dutton RJ, Turnbaugh PJ. Diet rapidly and reproducibly alters the human gut microbiome. Nature. 2014 Jan 23;505(7484):559-63. doi: 10.1038/nature12820. Epub 2013 Dec 11.
- Background: PubMed 22907164Manichanh C, Borruel N, Casellas F, Guarner F. The gut microbiota in IBD. Nat Rev Gastroenterol Hepatol. 2012 Oct;9(10):599-608. doi: 10.1038/nrgastro.2012.152. Epub 2012 Aug 21.
- Individual participant dataSharing planned: Yes. Requests from investigators will be evaluated on a case by case basis. Data that may be shared include lab values, patient reported outcomes, questionnaires, and microbiome sequences. Specimens may also be shared. Researchers can request data from the study's Principal Investigator in writing.
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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.
Timothy L Zisman, MD, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet 1 and Diet 2 in people with Crohn Disease, run by University of Washington 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 5 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 17 May 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Timothy L Zisman, MD, MPH (206-543-3220, tzisman@medicine.washington.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal Calprotectin Remission (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03012542, which also lists 5 linked publications.
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 17 May 2018.