Crohn's Disease and Colitis Trial, Recruiting NCT07013578 Sponsor: TIDHI Innovation Inc. Condition: Crohn's Disease and Colitis
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Crohn's Disease and Colitis Trial, Recruiting

NCT07013578
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:

  • You must be willing to sign a consent form agreeing to take part in the study.
  • You must be between 18 and 75 years old and have a confirmed diagnosis of Inflammatory Bowel Disease (IBD), such as Crohn's disease or ulcerative colitis.
  • You must have scored between 10 and 15 on a standard anxiety questionnaire (GAD7) and/or a standard depression questionnaire (PHQ9), which suggests moderate symptoms.
  • You must be able to take part fully in all parts of the trial.
  • You must be an IBD patient who plans to continue receiving ongoing medical care at the TIDHI clinic.

Who may not be able to join:

  • You are planning to change your IBD medications within 3 months after your initial screening appointment.
  • You have a serious mental health condition such as schizophrenia or bipolar disorder.
  • You are planning to change any psychiatric (mental health) medications you are currently taking within 3 months after your initial screening appointment.
  • You have a history of illegal drug use (not including marijuana) or alcohol misuse that, in the opinion of the study doctor, could make it difficult for you to follow the study procedures.

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 28 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: Mark Silverberg, MD, PhD, TIDHI Innovation Inc.

Phone: 647-812-2113

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
TIDHI Innovation Inc.
Registry
ClinicalTrials.gov
Start date
22 July 2025
Est. completion
31 December 2026

Where this trial is recruiting

🇨🇦 Canada

Primary endpoints

Change in Generalized Anxiety Disorder 7-item Scale (GAD-7) Score; Time to Improvement in Generalized Anxiety Disorder 7-item Scale (GAD-7) Score; Change in Patient Health Questionnaire-9 (PHQ-9) Score; Time to Improvement in Patient Health Questionnaire-9 (PHQ-9) Score

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: 28 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