Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06146816
Status:
RECRUITING
Last Update Posted:
2023-12-26
First Post:
2023-11-19
Brief Title:
The Assessment of Infrared Treatment for Crohns Disease
Sponsor:
Eli Sprecher MD
Organization:
Tel-Aviv Sourasky Medical Center
Study Overview
Official Title:
An Exploratory Clinical Trial for the Assessment of Infrared Treatment for Crohns Disease
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to test the safety and efficacy of far Infra-red fIR therapy in Crohns disease patients
The main questions it aims to answer are
1 Is infrared therapy safe for treating Crohns disease patients
2 Is infrared therapy effective for treating Crohns disease
Participants will be asked to attend 10 treatments of fIR therapy provide stool and blood samples and answer questionnaires
Researchers will compare between high intensity fIR therapy and lowest intensity fIR therapy placebo to see if high intensity fIR therapy is an effective treatment for Crohns disease
The main questions it aims to answer are
1 Is infrared therapy safe for treating Crohns disease patients
2 Is infrared therapy effective for treating Crohns disease
Participants will be asked to attend 10 treatments of fIR therapy provide stool and blood samples and answer questionnaires
Researchers will compare between high intensity fIR therapy and lowest intensity fIR therapy placebo to see if high intensity fIR therapy is an effective treatment for Crohns disease
Detailed Description:
Inflammatory bowel diseases IBD including Crohns 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 Crohns disease with photobiomodulation in the infrared IR range Preliminary data suggest a positive effect of IR on Crohns 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
Due to the documented effects of IR therapy on inflammation and its favorable safety profile the investigator would like to assess its effect on Crohns disease A skilled staff member will use a device emitting fIR radiation 8-10 microns that is able to penetrate deep into the body up to at least 20 cm according to manufacturer The device comprises a heating pad that emits heat up to 70 degree C alongside fIR radiation
Prior to treatment patients bowel will be assessed by intestinal ultrasound IUS CT MRI to determine the location of inflammation in order to focalize treatment but also to rule out the presence of abscess and cysts
All patients will undergo 10 sessions of 30 minutes fIR therapy at the IBD clinic of the Tel Aviv Medical Center 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 HBI3 andor 50 reduction in calprotectin who did not achieve remission can continue for 10 more treatments Patients who are allocated to the control group will be eligible to transfer to the experimental group after 10 sessions and receive 10 treatments with a high intensity fIR
After the completion of treatments at week 11 bowel thickness will be assessed again by IUS as well as biochemical and clinical indexes
Clinical score will be assessed using the Harvey-Bradshaw index HBI at weeks 0 5 and 10
Stool will be collected at weeks 0 5 and 10 for fecal calprotectin analysis and for future microbiomeproteomics analysis
Blood will be collected at weeks 0 5 and 10 for C reactive protein CRP complete blood count CBC liver function tests creatinine and lipase Serum will be frozen for future proteomics and inflammatory measures analysis Total blood volume will be less than 20ml
Patients will be asked to complete questionnaires evaluating their quality of life and disease related symptoms and outcomes
Side effects such as local skin thermal injury and blood tests abnormalities will be documented In case of local skin thermal injury patients will be examined to determine injury level with recommendation to apply Aloe Vera paste and a follow-up call will be made to document resolution of symptoms within 2 days
Throughout the research period patients will be asked to maintain their usual lifestyle with regards to nutrition and physical activity habits
Statistics Test results clinical indexes and side effects will be compared between experimental and control groups prior to- and post treatment These measures will also be analyzed within groups to compare pre- and post-treatment results
Patients in both groups will be categorized by disease severity level according to HBI in order to correlate disease severity with treatment efficacy Patients will be randomized according to disease severity in order to keep an equal rate of patients with mild clinical disease activity upon recruitment
All statistical analyses will be performed using SPSS version 230 for Windows Demographic characteristics of the population will be described by meanSD for continuous variables while categorical variables will be displayed as a frequency table
Normal distribution will be tested by Kolmogorov-Smirnov test If normality is rejected non-parametric tests will be used
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 Crohns disease with photobiomodulation in the infrared IR range Preliminary data suggest a positive effect of IR on Crohns 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
Due to the documented effects of IR therapy on inflammation and its favorable safety profile the investigator would like to assess its effect on Crohns disease A skilled staff member will use a device emitting fIR radiation 8-10 microns that is able to penetrate deep into the body up to at least 20 cm according to manufacturer The device comprises a heating pad that emits heat up to 70 degree C alongside fIR radiation
Prior to treatment patients bowel will be assessed by intestinal ultrasound IUS CT MRI to determine the location of inflammation in order to focalize treatment but also to rule out the presence of abscess and cysts
All patients will undergo 10 sessions of 30 minutes fIR therapy at the IBD clinic of the Tel Aviv Medical Center 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 HBI3 andor 50 reduction in calprotectin who did not achieve remission can continue for 10 more treatments Patients who are allocated to the control group will be eligible to transfer to the experimental group after 10 sessions and receive 10 treatments with a high intensity fIR
After the completion of treatments at week 11 bowel thickness will be assessed again by IUS as well as biochemical and clinical indexes
Clinical score will be assessed using the Harvey-Bradshaw index HBI at weeks 0 5 and 10
Stool will be collected at weeks 0 5 and 10 for fecal calprotectin analysis and for future microbiomeproteomics analysis
Blood will be collected at weeks 0 5 and 10 for C reactive protein CRP complete blood count CBC liver function tests creatinine and lipase Serum will be frozen for future proteomics and inflammatory measures analysis Total blood volume will be less than 20ml
Patients will be asked to complete questionnaires evaluating their quality of life and disease related symptoms and outcomes
Side effects such as local skin thermal injury and blood tests abnormalities will be documented In case of local skin thermal injury patients will be examined to determine injury level with recommendation to apply Aloe Vera paste and a follow-up call will be made to document resolution of symptoms within 2 days
Throughout the research period patients will be asked to maintain their usual lifestyle with regards to nutrition and physical activity habits
Statistics Test results clinical indexes and side effects will be compared between experimental and control groups prior to- and post treatment These measures will also be analyzed within groups to compare pre- and post-treatment results
Patients in both groups will be categorized by disease severity level according to HBI in order to correlate disease severity with treatment efficacy Patients will be randomized according to disease severity in order to keep an equal rate of patients with mild clinical disease activity upon recruitment
All statistical analyses will be performed using SPSS version 230 for Windows Demographic characteristics of the population will be described by meanSD for continuous variables while categorical variables will be displayed as a frequency table
Normal distribution will be tested by Kolmogorov-Smirnov test If normality is rejected non-parametric tests will be used
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None