NCT04505410CompletedPhase 3
Second Line Induction Therapy and Healthy Diet for Patients With Ulcerative Colitis
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
Source: ClinicalTrials.gov · Last updated 28 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 32 (actual)
- First submitted
- 5 Aug 2020
- Start date
- 18 Sept 2020
- Primary completion date
- 7 Dec 2023
- Lead sponsor
- University of Miami
- Diseases
- Ulcerative colitis
- NCT number
- NCT04505410
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 32
- From 18 Sept 2020 to the primary completion date, 7 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with concomitant infectious colitis.
- Prohibited concomitant therapies will include TNF antagonists, azathioprine, methotrexate, and mercaptopurine.
Other illness
- Patients allergic nuts/soy/sesame/oats.
- Individuals with a history of syncope/presyncope with fasting or from medical conditions.
- Patients with the following comorbidities: chronic kidney disease, diabetes, active cancer.
Lab values
- Patients that are diabetics on a glucose lowering drug.
Age
- Patients younger than 18 years.
Other
- 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 who do not like the food items that form part of the kits for the fasting mimicking diet (see below).
- Women who are pregnant or nursing.
- Individuals with very low BMI\< or equal to 18.
- Patients who routinely have fasting eating habits
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The University of Miami Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.