Crohn's DiseaseFACESNCT01926730
Food and Crohn's Exacerbation Study (FACES)
A study testing Restriction diet in people with Crohn's Disease, run by University of Pennsylvania at 1 site in United States.
Trial summary
The proposed study is a randomized controlled trial of a limited restriction diet compared to a regular diet among patients with Crohn's disease (CD) in remission. At baseline, patients will complete a semi-quantitative food frequency questionnaire assessing usual dietary patterns over the preceding month. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Restriction diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Jun 2016
- 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
- Patients must have an established diagnosis of CD.
- All patients must be in clinical remission at the time of entry into the study. Remission is defined as an aCDAI of less than 150.
Who cannot join
- Inflammatory bowel disease (IBD) unspecified / Indeterminate colitis
- Total or sub-total colectomy, ileostomy, or colostomy
- Unable to read and speak English
- No internet access
- Steroids other than budesonide ≤6mg/day with the prior two weeks
- Perianal fistula or abscess with more than scant drainage
Show all 9Show fewer
- Age less than 18 years
- Pregnant or breastfeeding women
- Unwilling to follow the study diet
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
The proposed study is a randomized controlled trial of a limited restriction diet compared to a regular diet among patients with Crohn's disease (CD) in remission. At baseline, patients will complete a semi-quantitative food frequency questionnaire assessing usual dietary patterns over the preceding month. Disease activity will be assessed with the abbreviated Crohn's Disease Activity Index (aCDAI)59. Self-reported disease status will be assessed during follow-up using an internet-based questionnaire. Repeat assessment of adherence to the study diets will be assessed with food frequency questionnaires (FFQs) administered after 20 weeks. Follow-up duration will be for 48 weeks. Statistical analysis will compare the time to relapse using Cox regression for patients in the two study arms. In the exploratory aim, we will compare outcomes among patients in the highest tertile for other food items and nutrients to those in the lowest tertile based on self-reported usual dietary patterns at baseline. Thus, the study population will be analyzed both as a randomized controlled trial and as a prospective cohort study.
- Conditions
- Crohn's Disease
- Being tested
- Restriction 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.
Restriction dietOther
Selected food items will be limited in the participants diet
| Study group | Role | What they receive |
|---|---|---|
| Usual diet | No intervention | Patients will follow a usual diet and consume at least 16 oz of water per day |
| Restriction diet | Experimental | Participants will follow a diet that limits intake of selected food items. Patients will consume at least 16 oz of water per day. Receives: Other: Restriction diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse of Crohn's Disease (CD)
Relapse of CD is defined as an increase in the aCDAI by >=60 points and to >150. Additionally, undergoing CD surgery or starting any new CD medication (steroids, mesalamine, azathioprine, methotrexate, anti-Tumor Necrosis Factor α (anti-TNF), anti-α4) for the treatment of CD symptoms during the interval between two visits will be considered to have identified a clinical relapse.
Measured: Every 8 weeks during the 48 week study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2013 (estimated)
- Study startNov 2013
- Primary completionJun 2016
- Study completionJun 2016
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 University of PennsylvaniaThe 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
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Crohn's and Colitis Foundation
- Responsible party
- Sponsor
- Investigators
- James D Lewis, MD, MSCE, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01926730
- Sponsor's protocol ID
- K24-DK078228-FACES
- Other IDs
- K24DK078228
- Acronym
- FACES
- Status last verified
- Feb 2017
- First submitted
- 18 Aug 2013
- Last updated
- 14 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food and Crohn's Exacerbation Study (FACES)
- ClinicalTrials.gov ID
- NCT01926730
- Acronym / sponsor ID
- FACES / K24-DK078228-FACES
- Conditions
- Crohn's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Crohn's and Colitis Foundation
- Study start
- Nov 2013 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 21 Aug 2013 (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 proposed study is a randomized controlled trial of a limited restriction diet compared to a regular diet among patients with Crohn's disease (CD) in remission. At baseline, patients will complete a semi-quantitative food frequency questionnaire assessing usual dietary patterns over the preceding month. Disease activity will be assessed with the abbreviated Crohn's Disease Activity Index (aCDAI)59. Self-reported disease status will be assessed during follow-up using an internet-based questionnaire. Repeat assessment of adherence to the study diets will be assessed with food frequency questionnaires (FFQs) administered after 20 weeks. Follow-up duration will be for 48 weeks. Statistical analysis will compare the time to relapse using Cox regression for patients in the two study arms. In the exploratory aim, we will compare outcomes among patients in the highest tertile for other food items and nutrients to those in the lowest tertile based on self-reported usual dietary patterns at baseline. Thus, the study population will be analyzed both as a randomized controlled trial and as a prospective cohort study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual diet | No intervention | –Patients will follow a usual diet and consume at least 16 oz of water per day |
| Restriction diet | Experimental | Other: Restriction dietParticipants will follow a diet that limits intake of selected food items. Patients will consume at least 16 oz of water per day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients must have an established diagnosis of CD.
- All patients must be in clinical remission at the time of entry into the study. Remission is defined as an aCDAI of less than 150.
Key exclusion criteria (9 listed)
- Inflammatory bowel disease (IBD) unspecified / Indeterminate colitis
- Total or sub-total colectomy, ileostomy, or colostomy
- Unable to read and speak English
- No internet access
- Steroids other than budesonide ≤6mg/day with the prior two weeks
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 |
|---|---|---|
| Restriction dietSelected food items will be limited in the participants diet | Other | Restriction diet |
Primary outcome
Relapse of Crohn's Disease (CD)
Time frame: Every 8 weeks during the 48 week study period
Relapse of CD is defined as an increase in the aCDAI by >=60 points and to >150. Additionally, undergoing CD surgery or starting any new CD medication (steroids, mesalamine, azathioprine, methotrexate, anti-Tumor Necrosis Factor α (anti-TNF), anti-α4) for the treatment of CD symptoms during the interval between two visits will be considered to have identified a clinical relapse.
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 14 Feb 2017.
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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.
James D Lewis, MD, MSCE principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restriction diet in people with Crohn's Disease, run by University of Pennsylvania 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 2 inclusion and 9 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 14 Feb 2017. 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?
Relapse of Crohn's Disease (CD) (time frame: Every 8 weeks during the 48 week study period). 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 14 Feb 2017.