Ulcerative ColitisPhase 3NCT04505410
Second Line Induction Therapy and Healthy Diet for Patients With Ulcerative Colitis
A Phase 3 study testing A plant based high fiber diet that mimics fasting ("FMD") plus advanced therapy and Advanced therapy only without dietary intervention in people with Ulcerative Colitis, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a diet intervention (the Fasting Mimicking diet) will help induce clinical and biochemical response to an advanced therapy in patients with ulcerative colitis. Study period will be 8 weeks during induction of advanced therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- A plant based high fiber diet that mimics fasting ("FMD") plus advanced therapy and Advanced therapy only without dietary intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2020to 7 Dec 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 with ulcerative colitis who are beginning tofacitinib therapy.
- Patients with ulcerative colitis who are initiating second line biologic therapy with ustekinumab
- Patients with ulcerative colitis who are initiating second line biologic therapy with infliximab
- Patients aged 18 years or older.
- Patients with active disease defined as simple clinical colitis activity index (SCCAI) >2
- Patients who have not been on antibiotics for 2 weeks or probiotics.
Who cannot join
- Patients younger than 18 years.
- Patients that do not meet the inclusion criteria specified above.
- Patients with clinical signs of fulminant colitis, toxic megacolon, ischemic colitis or impending hospitalization for severe ulcerative colitis.
- Patients with concomitant infectious colitis.
- Patients allergic nuts/soy/sesame/oats.
- Patients who do not like the food items that form part of the kits for the fasting mimicking diet (see below).
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- Patients that are diabetics on a glucose lowering drug.
- Individuals with a history of syncope/presyncope with fasting or from medical conditions.
- Women who are pregnant or nursing.
- Individuals with very low BMI< or equal to 18.
- Patients with the following comorbidities: chronic kidney disease, diabetes, active cancer.
- Prohibited concomitant therapies will include TNF antagonists, azathioprine, methotrexate, and mercaptopurine.
- Patients who routinely have fasting eating habits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Control Study to Examine the Influence of a Healthy Diet on Moderate to Severe Ulcerative Colitis Patients Undergoing Second Line Induction With Advanced Therapies
The purpose of this study is to determine whether a diet intervention (the Fasting Mimicking diet) will help induce clinical and biochemical response to an advanced therapy in patients with ulcerative colitis. Study period will be 8 weeks during induction of advanced therapies. The primary aims of this study will be clinical response, as determined by the simple clinical colitis activity index (SCCAI). Secondary outcomes will be improvement in fecal calprotectin and C-reactive protein levels.
Read the detailed description
Advanced therapies included will be:
JAK inhibitors (tofacitinib or upadacitinib) IL-23 inhibitors (ustekinumab or risankizumab) Anti-TNF (infliximab)
Patients will be provided these medications as part of their standard of care, as decided by their treating physician.
- Conditions
- Ulcerative Colitis
- Being tested
- A plant based high fiber diet that mimics fasting ("FMD") plus advanced therapy, Advanced therapy only without dietary intervention
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A plant based high fiber diet that mimics fasting ("FMD") plus advanced therapyOther
Patients will do two 5-day cycles of a fasting mimicking diet. They will start the first diet cycle 1 week after initiating a new advanced therapy: Tofacitinib and Upadacitinib (JAK inhibitors), Infliximab (anti-TNF), Ustekinumab or Risankizumab (IL-23 inhibitors).
Advanced therapy only without dietary interventionDrug
Patients in this group will start an advanced therapy and follow a diet solely based on dietary tolerance: new advanced therapy: Tofacitinib and Upadacitinib (JAK inhibitors), Infliximab (anti-TNF), Ustekinumab or Risankizumab (IL-23 inhibitors).
| Study group | Role | What they receive |
|---|---|---|
| Medication plus FMD group | Experimental | Participants in this group with UC consuming a standard, regular low-fiber diet will start an advanced therapy for eight consecutive weeks with the addition of two, five-day cycles of Fast Mimicking Diet (FMD) daily meals on weeks 2 and 7. Receives: Other: A plant based high fiber diet that mimics fasting ("FMD") plus advanced therapy |
| Medication only group | Active comparator | Participants in this group with UC consuming a diet based on tolerance will start an advanced therapy for eight consecutive weeks. Receives: Drug: Advanced therapy only without dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Who Achieved Clinical Response
Clinical response will be evaluated using the Simple Clinical Colitis Activity Index (SCCAI). The SCCAI has a total range from 0-19 with a higher score indicating greater disease activity. A clinical response is defined as a SCCAI decrease of ≥3 points from baseline. Therefore, the study team will examine the percentage of patients who achieve 'clinical response', defined by an SCCAI decrease of ≥3 points.
Measured: 8 weeks
Secondary outcomes (2)
Fecal Calprotectin Levels Measured in Micrograms/Gram
Calprotectin levels were evaluated using fecal samples to compare the levels between the treatment and control arms before (baseline) and after the intervention (at 8 weeks). Fecal calprotectin was measured using a BUHLMANN fCAL ELISA Kit. Unit of measure was micrograms/gram.
Measured: baseline, 8 weeks
CRP Levels Measured in mg/dl
Comparison of Median C-Reactive Protein (CRP) levels between the treatment and control arms before (baseline) and after the intervention (at 8 weeks) will be evaluated using blood samples, unit of measure was mg/dl
Measured: baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start18 Sep 2020
- Primary completion7 Dec 2023
- Study completion7 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Oriana Mazorra Damas, University of Miami
- Investigators
- Oriana Damas, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04505410
- Sponsor's protocol ID
- 20200436
- Status last verified
- Feb 2025
- First submitted
- 5 Aug 2020
- Last updated
- 28 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data and code are available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Study to Examine the Influence of a Healthy Diet on Moderate to Severe Ulcerative Colitis Patients Undergoing Second Line Induction With Advanced Therapies
- ClinicalTrials.gov ID
- NCT04505410
- Acronym / sponsor ID
- 20200436
- Conditions
- Ulcerative Colitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 18 Sep 2020 (actual)
- Primary completion
- 7 Dec 2023 (actual)
- Study completion
- 7 Dec 2023 (actual)
- First posted
- 10 Aug 2020 (actual)
- Results
- Posted 30 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether a diet intervention (the Fasting Mimicking diet) will help induce clinical and biochemical response to an advanced therapy in patients with ulcerative colitis. Study period will be 8 weeks during induction of advanced therapies. The primary aims of this study will be clinical response, as determined by the simple clinical colitis activity index (SCCAI). Secondary outcomes will be improvement in fecal calprotectin and C-reactive protein levels.
Detailed description
Advanced therapies included will be:
JAK inhibitors (tofacitinib or upadacitinib) IL-23 inhibitors (ustekinumab or risankizumab) Anti-TNF (infliximab)
Patients will be provided these medications as part of their standard of care, as decided by their treating physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medication plus FMD group | Experimental | Other: A plant based high fiber diet that mimics fasting ("FMD") plus advanced therapyParticipants in this group with UC consuming a standard, regular low-fiber diet will start an advanced therapy for eight consecutive weeks with the addition of two, five-day cycles of Fast Mimicking Diet (FMD) daily meals on weeks 2 and 7. |
| Medication only group | Active comparator | Drug: Advanced therapy only without dietary interventionParticipants in this group with UC consuming a diet based on tolerance will start an advanced therapy for eight consecutive weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with ulcerative colitis who are beginning tofacitinib therapy.
- Patients with ulcerative colitis who are initiating second line biologic therapy with ustekinumab
- Patients with ulcerative colitis who are initiating second line biologic therapy with infliximab
- Patients aged 18 years or older.
- Patients with active disease defined as simple clinical colitis activity index (SCCAI) >2
Key exclusion criteria (13 listed)
- Patients younger than 18 years.
- Patients that do not meet the inclusion criteria specified above.
- Patients with clinical signs of fulminant colitis, toxic megacolon, ischemic colitis or impending hospitalization for severe ulcerative colitis.
- Patients with concomitant infectious colitis.
- Patients allergic nuts/soy/sesame/oats.
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 |
|---|---|---|
| A plant based high fiber diet that mimics fasting ("FMD") plus advanced therapyPatients will do two 5-day cycles of a fasting mimicking diet. They will start the first diet cycle 1 week after initiating a new advanced therapy: Tofacitinib and Upadacitinib (JAK inhibitors), Infliximab (anti-TNF), Ustekinumab or Risankizumab (IL-23 inhibitors). | Other | Medication plus FMD group |
| Advanced therapy only without dietary interventionPatients in this group will start an advanced therapy and follow a diet solely based on dietary tolerance: new advanced therapy: Tofacitinib and Upadacitinib (JAK inhibitors), Infliximab (anti-TNF), Ustekinumab or Risankizumab (IL-23 inhibitors). | Drug | Medication only group |
Primary outcome
Percentage of Patients Who Achieved Clinical Response
Time frame: 8 weeks
Clinical response will be evaluated using the Simple Clinical Colitis Activity Index (SCCAI). The SCCAI has a total range from 0-19 with a higher score indicating greater disease activity. A clinical response is defined as a SCCAI decrease of ≥3 points from baseline. Therefore, the study team will examine the percentage of patients who achieve 'clinical response', defined by an SCCAI decrease of ≥3 points.
2 secondary outcomes
Fecal Calprotectin Levels Measured in Micrograms/Gram
Time frame: baseline, 8 weeks
CRP Levels Measured in mg/dl
Time frame: baseline, 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Data and code are available upon request.
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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.
Oriana Damas, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing A plant based high fiber diet that mimics fasting ("FMD") plus advanced therapy and Advanced therapy only without dietary intervention in people with Ulcerative Colitis, run by University of Miami 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 13 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 28 Feb 2025. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Patients Who Achieved Clinical Response (time frame: 8 weeks). 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 28 Feb 2025.