Low level laser therapy (LLLT) for Fecal Soiling

Phase-Based Estimates
1
Effectiveness
1
Safety
McMaster University, Hamilton, Canada
Fecal Soiling
Low level laser therapy (LLLT) - Device
Eligibility
Any Age
All Sexes
Eligible conditions
Fecal Soiling

Study Summary

This study is evaluating whether low level laser therapy will help people with severe fecal incontinence.

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Treatment Effectiveness

Study Objectives

This trial is evaluating whether Low level laser therapy (LLLT) will improve 1 primary outcome and 5 secondary outcomes in patients with Fecal Soiling. Measurement will happen over the course of 12 weeks.

12 weeks
Change in anal sphincter tone
Change in increase of anal sphincter pressure during squeezing
Change in squeezing duration
4 and 12 weeks
Change in symptoms score
Week 12
Change in Quality of Life
Change in number of fecal incontinence episodes

Trial Safety

Trial Design

2 Treatment Groups

Control
Incontinence and low level laser therapy

This trial requires 20 total participants across 2 different treatment groups

This trial involves 2 different treatments. Low Level Laser Therapy (LLLT) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Incontinence and low level laser therapy
Device
Intervention: Low level laser therapy (sacral neuromodulation or photobiomodulation) will be administered to patients with fecal incontinence
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Low level laser therapy (LLLT)
2021
N/A
~200

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 and 12 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 4 and 12 weeks for reporting.

Who is running the study

Principal Investigator
J. C.
Prof. Jihong Chen, Assistant Professor
McMaster University

Closest Location

McMaster University - Hamilton, Canada

Eligibility Criteria

This trial is for patients born any sex of any age. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients with fecal incontinence

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes fecal soiling?

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Data from a recent study demonstrates that fecal soiling may be related to an increase in stress hormone levels and a decrease in the level of neurotrophic factors.

Unverified Answer

Can fecal soiling be cured?

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Complete excision is a successful treatment of soiling induced by colonic motility disorders and may result in a significant improvement in quality of life but does not seem to be associated with complete recovery from soiling-induced bowel symptoms. Further prospective studies are warranted to confirm the long term efficacy of fecal soiling surgery in eradicating fecal incontinence.

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What are common treatments for fecal soiling?

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Most common treatments for fecal soiling have a limited role in helping control the frequency of fecal soiling. However, some patients may benefit if they have not controlled soiling by a single treatment.

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What are the signs of fecal soiling?

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Fecal soiling (faecal incontinence) has a variety of signs, including decreased desire to defecate, flatus accumulation, straining for defecation, loose stools and difficulty emptying the bowel.

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How many people get fecal soiling a year in the United States?

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The National Health Interview Survey 2011-2012 indicated about 17.8 million Americans had fecal soiling on at least one day in 2012. The frequency of soiling depends on which day in the year the respondent was asked about fecal soiling and what method of fecal disposal was used. In a recent study, findings highlight the need for improved reporting of fecal incontinence and greater efforts to make public health communications more relevant to the entire population.

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What is fecal soiling?

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Fecal soiling is the hallmark symptom of colonic motility disorders. In these patients, it is common for symptoms to mislead physicians into believing they have a bowel obstruction. A proper clinical history should be documented in all patients having an evaluation for a bowel motility disorder.

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What is low level laser therapy (lllt)?

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The data are discussed in terms of clinical interventions using low level laser therapy (LLLT). Recent findings point to the need to control for LLLT in the interpretation, rather than as a treatment in itself. LLLT deserves further investigation in patients suffering from fecal incontinence.

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What is the average age someone gets fecal soiling?

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There is less than an estimated 2.7% incidence of fecal soiling at the age of 1 year in young infants (<6months); and only 0.9% at 2 years. Therefore, fecal soiling is not an issue that requires special consideration in infant care.

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Does fecal soiling run in families?

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Findings from a recent study demonstrate that soiling is not, in fact, genetically predetermined. An environmental factor has to play an important role in this disease.

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How does low level laser therapy (lllt) work?

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The most likely explanation for the effect of low level laser on the defecation threshold for healthy adults is a reduction in norepinephrine. Nevertheless, the observed increase in stool hardness and fecal consistency are additional indications that the clinical effect on defecation is not mediated by the autonomic nervous system.

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Is low level laser therapy (lllt) safe for people?

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LLLT was well tolerated in people with colo-rectal cancer. No side effects were experienced despite the laser intensity>75 W/cm(2), which was far higher than the permissible exposure according to the National Council Against Health Hazardous Equipment guidelines.

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Is low level laser therapy (lllt) typically used in combination with any other treatments?

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Use of 1.8 mm and 2.5 mm wavelengths (for this retrospective review, we chose one device of each wavelength type) was not found to be more effective than placebo therapy in this population by any of the measures examined. Higher-quality studies are planned, but such trials may be difficult to design in this setting.

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