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New treatment option for Ulcerative Colitis (UC)
Official title Impact of Exclusion Diet in Addition to Anti-TNF Therapy in Crohn's Disease and Ulcerative Colitis: a Prospective, Randomized, Double-arm, Open-label Study
ClinicalTrials.gov ID: NCT06896305
What this study is testing
What is CDED (Crohn's Disease Exclusion Diet) in addition to anti-TNF therapy?
CDED (Crohn's Disease Exclusion Diet) in addition to anti-TNF therapy is an investigational medicine, being studied as a potential treatment for ulcerative colitis (uc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This clinical study protocol aims to prospectively compare the efficacy of standard therapy with anti-TNF agents combined with the Crohn's Disease Exclusion Diet (CDED) versus anti-TNF therapy alone in adult patients with active Crohn's disease or ulcerative colitis. The study will involve patients starting therapy with anti-TNF agents due to active Crohn's disease or ulcerative colitis as per standard clinical practice and in accordance with European (ECCO) guidelines.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participant is willing and able to give informed consent forparticipation in the study
- Males or Females, Adults aged 18 years or older
- Confirmed diagnosis of moderate-to-severe Crohn's disease orulcerative colitis
- Patients who are planned to start anti-TNF therapy
- Ability and willingness to comply with the Crohn's DiseaseExclusion Diet (CDED)
You likely can't join if
- Patients with undetermined inflammatory bowel disease
- Patients with metabolic or gastrointestinal conditions that couldinterfere or are incompatible with the study intervention (e.i.celiac disease...
- Patients with a body-mass index lower than 17 or greater than30
- Patients who previously underwent intestinal resectionirrespective of cause
- Patients currently on exclusive enteral nutrition (EEN)
- Patients who have previously used or are currently adhering toCDED
See the full eligibility criteria
- Participant is willing and able to give informed consent forparticipation in the study
- Males or Females, Adults aged 18 years or older
- Confirmed diagnosis of moderate-to-severe Crohn's disease orulcerative colitis
- Patients who are planned to start anti-TNF therapy
- Ability and willingness to comply with the Crohn's DiseaseExclusion Diet (CDED)
- Patients with undetermined inflammatory bowel disease
- Patients with metabolic or gastrointestinal conditions that couldinterfere or are incompatible with the study intervention (e.i.celiac disease, diabetes etc)
- Patients with a body-mass index lower than 17 or greater than30
- Patients who previously underwent intestinal resectionirrespective of cause
- Patients currently on exclusive enteral nutrition (EEN)
- Patients who have previously used or are currently adhering toCDED
- Pregnant or breastfeeding women
- Patients with a history of severe allergic reactions orintolerance to any food recommended in CDED
- Patients with significant comorbidities that may interfere withthe study or pose a risk to the participant
- Inability or unwillingness to comply with study protocols orfollow-up schedules
The study team makes the final eligibility decision.
Where it's taking place
- Milan, Michigan, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milan, Michigan, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.