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Neuromodulation Device
Low Level Laser Therapy for Chronic Constipation
N/A
Recruiting
Led By Jihong Chen, MD PhD
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have undergone high resolution colonic manometry that shows abnormal coordination between colonic motility and ano-rectal function.
Patients with severe chronic refractory constipation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This trial will study the effects of low level laser therapy on patients with chronic, severe constipation that has not responded to other treatments. There is no placebo group, so researchers will directly compare the results of the treatment.
Who is the study for?
This trial is for patients with severe chronic refractory constipation who have abnormal coordination between colonic motility and ano-rectal function, as shown by high resolution colonic manometry. It's not suitable for individuals with tattoos or light sensitivity in the treatment area, those taking NSAIDs or steroids, with malignancies or active bleeding in the treatment area, active deep vein thrombosis, or if pregnant.Check my eligibility
What is being tested?
The study is testing low level laser therapy to see if it can help people with severe chronic constipation. This proof of concept study does not include a placebo group; all participants will receive the actual laser therapy to assess its effectiveness.See study design
What are the potential side effects?
While specific side effects are not listed for this trial, low level laser therapy may potentially cause discomfort at the site of application, skin irritation, and in rare cases might lead to burns if improperly administered.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tests show my colon and rectum are not working together properly.
Select...
I have severe, long-lasting constipation that doesn't improve with treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in number of bowel movements/week
Secondary outcome measures
Anal spincter pressure
Autonomic function assessment
Change in anal sphincter pressure due to attempting defecation
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Refractory Constipation with LLLTExperimental Treatment1 Intervention
Low level laser therapy (LLLT) will be administered to patients with severe refractory chronic constipation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Low Level Laser Therapy
2013
Completed Phase 1
~680
Find a Location
Who is running the clinical trial?
McMaster UniversityLead Sponsor
881 Previous Clinical Trials
2,597,866 Total Patients Enrolled
Jihong Chen, MD PhDPrincipal InvestigatorMcMaster University
1 Previous Clinical Trials
20 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently experiencing bleeding in the area that needs treatment.I have cancer in the area where treatment is planned.You are pregnant.I take NSAIDs or steroids.You are sensitive to light.You have tattoos in the area where the treatment will be done.My tests show my colon and rectum are not working together properly.I have severe, long-lasting constipation that doesn't improve with treatment.I currently have a deep vein thrombosis.
Research Study Groups:
This trial has the following groups:- Group 1: Refractory Constipation with LLLT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any current openings to join this research program?
"According to the clinicaltrials.gov portal, this research is still open for recruitment and was first published on September 8th 2019 before being updated last April 4th 2022."
Answered by AI
Would I be eligible to join this medical study?
"In order to be eligible, patients need both suffer from dyschezia and find themselves between the ages of 6 and 70. This clinical trial is currently aiming to recruit 20 individuals."
Answered by AI
Do the criteria for this medical trial include individuals over 45 years of age?
"According to the entry requirements for this study, participants must be between 6 and 70 years old."
Answered by AI
What is the upper limit for enrolment in this clinical experiment?
"Affirmative. The information on clinicaltrials.gov indicates that this trial is actively enrolling patients, having been first posted on September 8th 2019 and last updated April 4th 2022. It requires 20 participants from one medical site in total."
Answered by AI
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