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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A plant based high fiber diet that mimics fasting ("FMD") plus advanced therapy | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oriana Damas, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Miami | Miami | Florida | 33136 | United States |
Data and code are available upon request.
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| ID | Title | Description |
|---|---|---|
| FG000 | Advanced Therapy Plus FMD Group | Participants in this group with UC will start an advanced therapy with the addition of two, five-day cycles of Fast Mimicking Diet (FMD) daily meals on weeks 2 and 6. Fast Mimicking Diet: FMD is a five day meal plan that includes foods such as soups, snacks, bards, teas and supplements (omega-3 fatty acids) for a total of 66 items per box. The diet is plant-based, gluten free and dairy free without any artificial preservatives, chemicals or biologically active ingredients. |
| FG001 | Advanced Therapy Only Group (no Diet Intervention) | Participants in this group with UC will initiate an advanced therapy and follow a diet based on dietary tolerances. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This is the participant flow diagram of all patients inlcuded in the study and analyzed in the intention to treat arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | Advanced Therapy Plus FMD Group | Participants in this group with UC 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. Fast Mimicking Diet: FMD is a five day meal plan that includes foods such as soups, snacks, bards, teas and supplements (omega-3 fatty acids) for a total of 66 items per box. The diet is plant-based, gluten free and dairy free without any artificial preservatives, chemicals or biologically active ingredients. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | percentage of patients | 8 weeks |
|
8 weeks
Any serious adverse event was reported to the sponsor of the study (Pfizer) and to the IRB. Pfizer funded this PI-initiated study.
Non-serious events were recorded by our team and followed up on.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Advanced Therapy Plus FMD Group (Diet Intervention) | 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 6. Medications started have been described previously. Fast Mimicking Diet: FMD is a five day meal plan that includes foods such as soups, snacks, bards, teas and supplements (omega-3 fatty acids) for a total of 66 items per box. The diet is plant-based, gluten free and dairy free without any artificial preservatives, chemicals or biologically active ingredients. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Immune system disorders | Systematic Assessment | Both patients who had serious adverse events were admitted to the hospital for flares related to their disease condition (ulcerative colitis). Although both patients were in the intervention group, neither had initiated the dietary intervention. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abdominal pain | Immune system disorders | Systematic Assessment |
|
First, due to the COVID pandemic, we were unable to reach the recruitment numbers. Another limitation: initial protocol designed to only examine patients initiating tofacitinib but delays in recruitment due to COVID, together with the approval of upadacitinib, led to poor recruitment. Then expanded criteria to include: upadacitinib and to patients initiating their second- or third-line biologic (infliximab, ustekinumab, or risankizumab). Also sample size was small.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Professor, Director of Translational Studies for the Crohn's and Colitis Center | University of Miami Miller School of Medicine | 3057733573 | odamas@med.miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 5, 2021 | Nov 22, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 23, 2023 | Dec 4, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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|
| Advanced therapy only without dietary intervention | Drug | 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). |
|
| 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 | baseline, 8 weeks |
| did not want to follow diet |
|
| flare up of ulcerative colitis |
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| Lost to Follow-up |
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| Lost to Follow-up |
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| initiated another diet on their own |
|
| BG001 | Advanced Therapy Only Group (no Diet Intervention) | Participants in this group with UC will be begin an advanced therapy and consume a a diet based on dietary tolerance. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Simple clinical colitis activity index | SCCAI is a symptom-based questionnaire addressing five assessments, including bowel frequency day, bowel frequency night, urgency of defecation, blood in stool and general well-being. The SCCAI has a total range from 0-19 with a higher score indicating greater disease activity. | Median | Inter-Quartile Range | units on a scale |
|
| OG001 | Advanced Therapy Without FMD (Medication Only Group) | Participants in this group with UC will initiate an advanced therapy as their standard of care. Patients will be provided guidance on following a diet based on dietary tolerances. |
|
|
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| Secondary | 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. | Posted | Mean | Full Range | mcg/gram | baseline, 8 weeks |
|
|
|
| Secondary | 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 | Posted | Median | Inter-Quartile Range | mg/dl | baseline, 8 weeks |
|
|
|
| 0 |
| 14 |
| 2 |
| 14 |
| 1 |
| 14 |
| EG001 | Advanced Therapy Only Group (no Diet Intervention) | Participants in this group with UC consuming a standard, regular low-fiber diet will be starting an advanced therapy (but not diet intervention). Medications started have been described previously. | 0 | 18 | 0 | 18 | 2 | 18 |
|
|
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| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |