Crohn's Disease and Colitis Trial, Recruiting NCT06896305 Sponsor: IRCCS Ospedale San Raffaele Condition: Crohn's Disease and Colitis
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Crohn's Disease and Colitis Trial, Recruiting

NCT06896305
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are willing and able to give informed consent to take part in the study
  • Adults aged 18 years or older, of any gender
  • People who have a confirmed diagnosis of moderate-to-severe Crohn's disease or ulcerative colitis
  • People whose doctor has planned for them to start a type of medication called anti-TNF therapy
  • People who are able and willing to follow a specific eating plan called the Crohn's Disease Exclusion Diet (CDED)

Who may not be able to join:

  • People whose inflammatory bowel disease has not been clearly identified as a specific type
  • People who have other metabolic or digestive conditions that could interfere with the study, such as celiac disease or diabetes
  • People whose body mass index (BMI) — a measure of body weight relative to height — is below 17 or above 30
  • People who have previously had part of their intestine surgically removed, for any reason
  • People who are currently on a feeding plan delivered entirely through a tube or liquid formula (called exclusive enteral nutrition)
  • People who have previously followed or are currently following the Crohn's Disease Exclusion Diet (CDED)
  • Women who are pregnant or breastfeeding
  • People with a history of severe allergic reactions or intolerance to any foods included in the CDED eating plan
  • People with serious other health conditions that could interfere with the study or create health risks
  • People who are unable or unwilling to follow the study's procedures or attend required follow-up appointments

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 16 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Tommaso Lorenzo Parigi, MD, IRCCS Ospedale San Raffaele

Phone: +39 02 2643 2756

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
IRCCS Ospedale San Raffaele
Registry
ClinicalTrials.gov
Start date
22 May 2025
Est. completion
1 April 2027

Where this trial is recruiting

🇮🇹 Italy

Primary endpoints

Efficacy of CDED in addition to anti-TNF therapy in active CD and UC versus anti-TNF therapy

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov