The Assessment of Infrared Treatment for Crohn's Disease

NCT06146816 | Recruiting

• 1 other identifier: 0669-22-TLV
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 1.Is infrared therapy safe for treating Crohn's disease patients?
2. 2.Is infrared therapy effective for treating Crohn's disease?

Conditions

IBD; Inflammatory Bowel Diseases; Crohn Disease

Keywords

inflammation; Infra-red

Outcome Measures

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.

  2 years

Secondary Outcomes (4)

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

  3 years

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

  3 years

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

  3 years

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

  3 years

Study Arms (4)

High intensity fIR therapy

EXPERIMENTAL

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.

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

Placebo arm

PLACEBO COMPARATOR

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.

Device: Photobiomodulation sham treatment

Low intensity fIR therapy

EXPERIMENTAL

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.

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

Medium intensity fIR therapy

EXPERIMENTAL

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.

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

Interventions

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.

High intensity fIR therapy

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

Low intensity fIR therapy

Photobiomodulation sham treatment DEVICE

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

Placebo arm

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

Medium intensity fIR therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• An established Crohn's disease
• \< 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.

You may not qualify if:

• 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
• Subjects with chronic conditions such as cancer, organ transplant subjects, advanced kidney or liver disease, systemic inflammatory conditions other than IBD.
• Presence of abscess and cysts in the liver/ kidneys or pancreas
• Evidence of an abdominal abscess or entero-enteric fistula.
• More than one CD luminal surgery or a small bowel length \< 1.5 meter

Sponsors & Collaborators

• Shmuel Kivity, MD: lead

Study Sites (1)

Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Inflammation

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nitsan Maharshak, Professor

  Department of Gastroenterology and Liver Diseases, Tel Aviv Medical Center, Tel Aviv, Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nitsan Maharshak, Professor

CONTACT

+972527360384; nitsanm@tlvmc.gov.il

Rony Izhar, PhD

CONTACT

+972504991116; ronyi@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: A randomized, single-blinded, 4 arms, pilot study. The investigator will recruit 40 CD patients suffering from an active disease based on clinical score and fecal calprotectin level. Thirty patients will be allocated to the three experimental groups and receive low, medium or high intensity fIR therapy (corresponding to 45˚C, 60˚C and 70˚C, respectively), while 10 patients will be allocated to the control group and receive placebo treatment. Another 10 patients will be recruited in case there is a drop-out. Rate of patients with mild disease (HBI 5-7) will be similar between the two groups.

Study Record Dates

• First Submitted: November 19, 2023
• First Posted: November 27, 2023
• Study Start: September 12, 2023
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)