An Exploratory Clinical Trial for the Assessment of Infrared Treatment for Crohn's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Assess the safety of fIR therapy for CD patients.
研究概览
简要总结
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:
- Is infrared therapy safe for treating Crohn's disease patients?
- 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.
详细描述
Inflammatory bowel diseases (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), are chronic relapsing diseases that carry considerable impact on patients' quality of life, including objective measures such as increased bowel movements, bleeding and fistulas and more subjective measures such as abdominal pain and fatigue.
While the pathogenesis of IBD is thought to result from a deregulated immune response towards microbial antigens in genetically predisposed people, various associations between environmental factors and disease activity have been described. Currently, standard IBD treatment relies on immune modulating drugs. However, such drugs may cause adverse effects, and up to 35% of patients show no response and up to 80% fail to achieve remission.
The investigator would like to explore treating Crohn's disease with photobiomodulation in the infrared (IR) range. Preliminary data suggest a positive effect of IR on Crohn's disease activity, and would like to conduct a small scale, pilot clinical trial to further clinically explore the safety and efficacy of this simple intervention.
Infrared is a safe, non-ionizing radiation spanning wavelengths from about 800 nanometers (nm) to 1 millimeter (mm). The therapeutic effects of IR radiation were serendipitously stumbled upon in the 1980s by NASA (National Aeronautics and Space Administration) scientists who noticed improvement in skin lesions when assessing IR light for growing potatoes in space. Since then, there has been a cautious advancement in assessing IR therapy for various conditions and an increased understanding of some of the mechanisms underlying its effect.
Alongside its beneficial effect, infrared treatment is not associated with serious adverse effects in general and with relation to fertility in particular. In fact, experimental data suggest that far IR (fIR) is safe for treating various medical conditions including cancer, diabetes and female infertility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •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
研究组 & 干预措施
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.
干预措施: High level photobiomodulation treatment in the infrared (IR) range. (Device)
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.
干预措施: Photobiomodulation sham treatment (Device)
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.
干预措施: Low level photobiomodulation treatment in the far infrared (IR) range (Device)
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.
干预措施: Medium level photobiomodulation treatment in the far infrared (IR) range (Device)
结局指标
主要结局
Assess the safety of fIR therapy for CD patients.
时间窗: 2 years
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.
次要结局
- 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)
研究者
Shmuel Kivity, MD
Professor
Tel-Aviv Sourasky Medical Center