Crohn's Disease Clinical Trials

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An Exploratory Clinical Trial for the Assessment of Infrared Treatment for Crohn's Disease

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to test the safety and efficacy of far Infra-red (fIR) therapy in Crohn's disease patients. The main questions it aims to answer are: 1. Is infrared therapy safe for treating Crohn's disease patients? 2. Is infrared therapy effective for treating Crohn's disease? Participants will be asked to attend 10 treatments of fIR therapy, provide stool and blood samples and answer questionnaires. Researchers will compare between 4 treatments: three intensities of fIR therapy and placebo treatment to explore which intensity is most effective for treating Crohn's disease.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• An established Crohn's disease

• 18 \< age \< 80

• No therapy or on constant medicinal regimen throughout the study period: mesalamine at least 6 weeks, or steroids at least 2 weeks, or immunomodulatory drugs at least 12 weeks or biologics at least 12 weeks, medical cannabis at least 2 weeks before the study.

• CD patients will be included if their symptoms score \>4 on the Harvey-Bradshaw index (HBI) score and/or fecal calprotectin level \> 150 ug/gr.

Locations
Other Locations
Israel
Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center
RECRUITING
Tel Aviv
Contact Information
Primary
Nitsan Maharshak, Professor
nitsanm@tlvmc.gov.il
+972527360384
Backup
Rony Izhar, PhD
ronyi@tlvmc.gov.il
+972504991116
Time Frame
Start Date: 2023-09-12
Estimated Completion Date: 2028-01
Participants
Target number of participants: 40
Treatments
Experimental: High intensity fIR therapy
Patients will undergo 10 sessions of 30 minutes high intensity (approximately 70˚C) fIR therapy at the IBD clinic of the TLVMC by a trained and qualified staff member. Each abdominal quadrant will receive a similar amount of time of exposure to the IR, except for the quadrant of the inflamed intestine (usually the right lower quadrant) which will be exposed longer to the IR. During the treatment, energy levels and skin temperature will be recorded at 10 minutes intervals. Patients responding to therapy (clinical response: ∆HBI≥3 and/or 50% reduction in calprotectin), who did not achieve remission can continue for 10 more treatments.
Placebo_comparator: Placebo arm
Patients will undergo 10 sessions of 30 minutes of placebo treatment, at the IBD clinic of the TLVMC by a trained and qualified staff member. Each abdominal quadrant will receive a similar amount of time of exposure, except for the quadrant of the inflamed intestine (usually the right lower quadrant) which will be exposed longer. During the treatment, energy levels and skin temperature will be recorded at 10 minutes intervals.
Experimental: Low intensity fIR therapy
Patients will undergo 10 sessions of 30 minutes of low intensity (approximately 45˚C) fIR therapy at the IBD clinic of the TLVMC by a trained and qualified staff member. Each abdominal quadrant will receive a similar amount of time of exposure to the IR, except for the quadrant of the inflamed intestine (usually the right lower quadrant) which will be exposed longer to the IR. During the treatment, energy levels and skin temperature will be recorded at 10 minutes intervals. Patients responding to therapy (clinical response: ∆HBI≥3 and/or 50% reduction in calprotectin), who did not achieve remission can continue for 10 more treatments.
Experimental: Medium intensity fIR therapy
Patients will undergo 10 sessions of 30 minutes of medium intensity (approximately 60˚C) fIR therapy at the IBD clinic of the TLVMC by a trained and qualified staff member. Each abdominal quadrant will receive a similar amount of time of exposure to the IR, except for the quadrant of the inflamed intestine (usually the right lower quadrant) which will be exposed longer to the IR. During the treatment, energy levels and skin temperature will be recorded at 10 minutes intervals. Patients responding to therapy (clinical response: ∆HBI≥3 and/or 50% reduction in calprotectin), who did not achieve remission can continue for 10 more treatments.
Related Therapeutic Areas
Sponsors
Leads: Shmuel Kivity, MD

This content was sourced from clinicaltrials.gov