Health TrialsbyHealthPanel

The Assessment of Infrared Treatment for Crohn's Disease

ConditionsIBDInflammatory Bowel DiseasesCrohn Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShmuel Kivity, MD

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

BMI greater than 30 Kg/m2

Any proven current infection such as Clostridioides difficile infection, positive stool culture, or parasites.

Inability to sign informed consent and complete study protocol

Pregnancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • High level photobiomodulation treatment in the infrared (IR) range.

    Device

    The baseline treatment included 10 weekly 30 minutes long sessions of high level fIR treatment.

  • Medium level photobiomodulation treatment in the far infrared (IR) range

    Device

    The baseline treatment included 10 weekly 30 minutes long session of medium level fIR treatments

  • Low level photobiomodulation treatment in the far infrared (IR) range

    Device

    The baseline treatment included 10 weekly 30 minutes long session of low level fIR treatments

  • Photobiomodulation sham treatment

    Device

    The baseline treatment includes 10 weekly 30 minutes long of sham fIR treatment.

Treatment groups

40 Participants
are divided into 4 treatment groups
Group A: High intensity fIR therapyExperimental treatment 1 intervention
Group B: Placebo armPlacebo comparator 1 intervention
Group C: Low intensity fIR therapyExperimental treatment 1 intervention
Group D: Medium intensity fIR therapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Assess the safety of fIR therapy for CD patients.

The investigator will document all adverse events and assess their severity. The only documented adverse event for fIR treatment in the currently available literature are first degree burns. Hence, the treatment will be considered safe if no additional adverse events will occur. Clinical and biochemical markers will be monitored for the possibility of disease exacerbation following fIR treatment.

Time frame
2 years

Secondary outcomes

1

Evaluate the relative efficacy of three FIR treatment intensities and compare each to control in achieving a composite response.

a composite response rate defined as a clinical response (drop of ≥3 points of the Harvey-Bradshaw Index (HBI) or HBI\<5) AND a decrease of fecal calprotectin (Fcal) by at least 50% from baseline or Fcal\<150ug/gr.

Time frame
3 years
2

Evaluate the relative efficacy of three FIR treatment intensities and compare each to control in achieving clinical remission.

Clinical remission is defined by HBI≤4

Time frame
3 years
3

Evaluate the relative efficacy of three FIR treatment intensities and compare each to control in achieving biomarker remission.

Biomarker remission is defined by normalization of Fcal\<150ugr/g

Time frame
3 years
4

Evaluate the relative efficacy of three FIR treatment intensities and compare each to control by rate of sonographic healing.

Measure rate of sonographic healing as assessed by IUS (intestinal ultrasound) and defined as bowel wall thickening ≤3 mm with no increase in color Doppler signal.

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shmuel Kivity, MD

Lead sponsor

Tel-Aviv Sourasky Medical Center

Sponsor institution

Source ClinicalTrials.gov
Apply now