What is the mechanism of action of this treatment?

Common treatments for chronic constipation include dietary fiber, laxatives, and neuromodulation techniques. Dietary fiber increases stool bulk and water content, promoting bowel movements. Laxatives work by softening stools, stimulating bowel contractions, or lubricating the intestinal tract. Neuromodulation techniques, such as sacral nerve stimulation, modulate nerve signals to improve bowel motility and function. Low Level Laser Therapy (Photobiomodulation) aims to stimulate cellular function and promote healing by using low-level lasers, which can enhance cellular energy production and reduce inflammation. These mechanisms are crucial for chronic constipation patients as they target the underlying dysfunctions in bowel motility and cellular health, potentially offering relief from symptoms and improving quality of life.

What side effects are associated with this type of intervention?

Common treatments for chronic constipation include dietary fiber supplements, laxatives, and newer pharmacologic agents like lubiprostone and linaclotide. Fiber supplements can cause bloating and gas. Laxatives, depending on their type, may lead to electrolyte imbalances, dependency, and abdominal cramping. Lubiprostone may cause nausea, diarrhea, and headache, while linaclotide can lead to diarrhea and abdominal pain. Low Level Laser Therapy (LLLT) for chronic constipation is still under investigation, but generally, LLLT is considered safe with minimal side effects, such as mild skin irritation or temporary discomfort at the treatment site.

What prior FDA approvals exist?

The provided context does not mention specific FDA approvals for treatments similar to Low Level Laser Therapy (LLLT) or Photobiomodulation for chronic constipation. However, traditional FDA-approved treatments for chronic constipation typically include medications such as laxatives, stool softeners, and prokinetic agents. These treatments aim to alleviate symptoms by promoting bowel movements and improving stool consistency. For more specific information on FDA-approved treatments, consulting a healthcare provider is recommended.

What other types of research exist?

Promising novel alternatives to Low Level Laser Therapy for chronic constipation in 2024 include Sacral Neuromodulation, which involves electrical stimulation of the sacral nerves to improve bowel function, and biofeedback therapy, which helps patients retrain their pelvic floor muscles. Additionally, new pharmacological agents targeting specific pathways involved in bowel motility and gut microbiota modulation through probiotics or fecal microbiota transplantation are also emerging as potential treatments.

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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

Must not have

Active bleeding in area of treatment

Known malignancies in the area of treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if a special light therapy can help people with severe constipation that doesn't improve with other treatments. The therapy involves multiple sessions over a few weeks. It aims to improve how nerves and muscles in the digestive system work together. Researchers will check if symptoms and quality of life improve after 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.

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.

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 below

Select...

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently experiencing bleeding in the area that needs treatment.

Select...

I have cancer in the area where treatment is planned.

Select...

I take NSAIDs or steroids.

Select...

I currently have a deep vein thrombosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in number of bowel movements/week

Secondary study objectives

Anal spincter pressure

Autonomic function assessment

Change in anal sphincter pressure due to attempting defecation

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

~800

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for chronic constipation include dietary fiber, laxatives, and neuromodulation techniques. Dietary fiber increases stool bulk and water content, promoting bowel movements. Laxatives work by softening stools, stimulating bowel contractions, or lubricating the intestinal tract. Neuromodulation techniques, such as sacral nerve stimulation, modulate nerve signals to improve bowel motility and function. Low Level Laser Therapy (Photobiomodulation) aims to stimulate cellular function and promote healing by using low-level lasers, which can enhance cellular energy production and reduce inflammation. These mechanisms are crucial for chronic constipation patients as they target the underlying dysfunctions in bowel motility and cellular health, potentially offering relief from symptoms and improving quality of life.

Kegel Exercises, Biofeedback, Electrostimulation, and Peripheral Neuromodulation Improve Clinical Symptoms of Fecal Incontinence and Affect Specific Physiological Targets: An Randomized Controlled Trial.