Crohn's Disease and Colitis Trial, Recruiting NCT07649408 Sponsor: Shmuel Kivity, MD Condition: Crohn's Disease and Colitis
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Crohn's Disease and Colitis Trial, Recruiting

NCT07649408
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 have been diagnosed with Crohn's Disease
  • People with currently active inflammation, shown by a symptom score of 5 or higher (HBI score) and either an elevated CRP blood marker or an elevated stool test result (calprotectin above 250 mcg/gr)
  • People who are already starting one of the following medications as part of their normal medical care: Anti-TNFs, vedolizumab, ustekinumab, IL-23 inhibitors, JAK inhibitors, or S1P inhibitors

Who may not be able to join:

  • People who are unable to give informed consent or complete the study requirements
  • Women who are pregnant or breastfeeding
  • People who are unwilling or unable to follow the study steps, including filling in questionnaires and wearing a watch while sleeping
  • People diagnosed with ulcerative colitis or a form of inflammatory bowel disease that has not been clearly defined as Crohn's Disease
  • People who have another sleep disorder, such as obstructive sleep apnea, overactive bladder, insomnia, shift work disorder, restless leg syndrome, periodic limb movement during sleep, or narcolepsy
  • People currently using sleep medications, such as benzodiazepines or cannabis
  • People who have had abdominal surgery in the past 4 weeks
  • People with a serious condition affecting the heart, kidneys, or liver, as assessed by their doctor
  • People who have an ileostomy (a surgically created opening in the abdomen) or short bowel syndrome

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 21 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.

GP referral letter

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Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Shmuel Kivity, MD
Registry
ClinicalTrials.gov
Start date
6 August 2025
Est. completion
1 October 2027

Where this trial is recruiting

🇮🇱 Israel

Primary endpoints

Improved sleep quality according to the Pittsburgh Sleep Quality Index (PSQI)

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: 21 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