Crohn's Disease and Colitis Trial, Not Yet Recruiting NCT06917443 Sponsor: Shmuel Kivity, MD Condition: Crohn's Disease and Colitis
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Crohn's Disease and Colitis Trial, Not Yet Recruiting

NCT06917443
Not Yet Recruiting Not Applicable

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not 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 may be able to join

  • People who are either not currently on any treatment, or who have been on a stable dose of certain medications for a set period — such as mesalamine for at least 6 weeks, low-dose steroids for at least 2 weeks, immunomodulatory drugs for at least 12 weeks, or biologics/small molecule drugs for at least 12 weeks (and the dose must remain constant throughout the study).
  • People who stopped certain medications before the study must have done so within specific timeframes — at least 2 weeks since stopping steroids or mesalamine, 4 weeks since stopping small molecule drugs, 8 weeks since stopping biologics, or 12 weeks since stopping thiopurines.
  • People with Crohn's disease who have a symptom score greater than 4 and no higher than 15 on a scale called the HBI score (confirm with trial site).
  • People with a specific marker of gut inflammation in their stool above a certain level, or signs of active disease shown on an intestinal ultrasound scan (confirm with trial site).

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People who are unable to commit to doing at least 10–15 minutes of exercise six times per week.
  • People who do not have access to, or are unable to use, a computer or the internet.
  • People who currently have a confirmed infection, such as a fever, an active abscess, a C. difficile infection, a positive stool culture, or a parasite (in those with ongoing diarrhoea).
  • People who are unable to sign a consent form or complete the study requirements.
  • People who are not able to provide informed consent for any reason.
  • People who are pregnant, planning to become pregnant, or are within 3 months of giving birth.
  • People who have certain ongoing health conditions, including active arthritis, a cancer diagnosis within the past 5 years (excluding certain minor skin cancers), a history of organ transplant, advanced kidney or liver disease, or other ongoing inflammatory conditions besides IBD.
  • People who have had surgery in the past 3 months, more than one bowel resection surgery, or who have a stoma bag, an internal pouch, or a significantly shortened small intestine (less than 1.5 metres).
  • People with a significant hernia in the abdominal wall, unless a written confirmation has been provided by a treating surgeon.
  • People with active disease around the anal area (such as a fistula, abscess, or fissure), or disease that causes narrowing or penetration of the bowel.
  • People with active complications of IBD affecting areas outside the gut (minor mouth ulcers and joint pain without full arthritis are not excluded).
  • People who are receiving nutrition entirely through a drip into a vein, or exclusively through a feeding tube.
  • People who have taken probiotics or antibiotics in the 15 days before enrolling or who would need to take them during the study.

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 30 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: Nitsan Maharshak, Professor, Tel Aviv Medical Center

Phone: +972527360384

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
Not Yet Recruiting
Phase
Not Applicable
Sponsor
Shmuel Kivity, MD
Registry
ClinicalTrials.gov
Start date
1 April 2025
Est. completion
1 April 2029

Where this trial is recruiting

🇮🇱 Israel

Primary endpoints

Clinical response rate; Clinical remission rate; Biomarker remission rate; Biomarker remission rate; Change from Baseline in mean values of PROMIS-29 scores; Change from Baseline in mean values of IBDQ

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: 30 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