What side effects are associated with this type of intervention?

Common treatments for constipation include the use of laxatives, stool softeners, and dietary changes such as increased fiber intake. Laxatives, which can be osmotic, stimulant, or bulk-forming, often cause side effects like bloating, gas, cramping, and diarrhea. Stool softeners may lead to mild abdominal cramping and diarrhea. Increasing dietary fiber can sometimes result in bloating and gas. It is important to use these treatments under medical supervision to manage side effects effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for constipation, including polyethylene glycol (PEG) laxatives, which are commonly used for their efficacy in increasing bowel movements. Other approved medications include prucalopride, a serotonin-4 receptor agonist that enhances colonic motility, and lubiprostone, a chloride channel activator that increases intestinal fluid secretion. These treatments aim to alleviate symptoms of chronic constipation by improving bowel function and are supported by clinical trials demonstrating their safety and efficacy.

What other types of research exist?

Promising novel alternatives for diagnosing constipation in 2024 include: 1) Magnetic Resonance Imaging (MRI) techniques such as MR enterography, which provide detailed images of the bowel without ionizing radiation. 2) Multispectral Optoacoustic Tomography (MSOT), a noninvasive imaging method that assesses bowel activity and inflammation. 3) Advanced stool-based tests that analyze biomarkers like fecal calprotectin and lactoferrin to differentiate between functional and inflammatory bowel disorders. These methods offer improved diagnostic accuracy and patient compliance.

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Diagnostic Tests for Gut Transit in Constipation

N/A

Recruiting

Led By Adil E Bharucha, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Active rectal inflammation, cancer; perianal sepsis; history of pelvic radiation, rectosigmoid surgery or inflammatory bowel disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

No Placebo-Only Group

Summary

This trial involves answering health questions, providing samples, and undergoing rectal tests to understand constipation better and improve diagnosis.

Who is the study for?

This trial is for men and women aged 18-80 who've had chronic constipation for at least a year, with symptoms like fewer than three bowel movements per week or the feeling of incomplete evacuation. It's not open to pregnant individuals, prisoners, those with significant health issues that could interfere with the study, or anyone on medications affecting gastrointestinal motility.

What is being tested?

The study aims to understand constipation better by using two tests: Fecoflowmetry and Rectal Barostat Study. These tests measure how well stool moves through the body and how sensitive the rectum is, which might help diagnose defecation disorders more accurately.

What are the potential side effects?

Since this trial involves diagnostic procedures rather than medication or invasive treatments, side effects are minimal but may include temporary discomfort during testing.

Eligibility Criteria

Exclusion Criteria

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

Select...

I have no active rectal issues, past major rectal surgeries, or inflammatory bowel disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

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

Treatment Details

Study Objectives

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

Primary study objectives

Rectal emptying

Rectoanal pressures

Secondary study objectives

Anal sphincter electromyography (EMG)

Rectal Capacity measured with a barostat

Rectal balloon expulsion time

+5 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Active Control

Group I: Healthy IndividualsActive Control2 Interventions

Sixty healthy individuals (20 men and 40 women) will undergo an anorectal study which comprises of a rectal barostat study followed by fecoflowmetry

Group II: Constipated IndividualsActive Control2 Interventions

60 constipated individuals (20 men and 40 women) will undergo an anorectal study which comprises of a rectal barostat study followed by fecoflowmetry

0 / 1Eligibility 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 constipation include fiber supplements, laxatives, and prokinetic agents. Fiber supplements, such as psyllium, increase stool bulk and promote regular bowel movements by absorbing water. Laxatives, including osmotic agents like polyethylene glycol and stimulant laxatives like bisacodyl, work by drawing water into the intestines or stimulating bowel contractions, respectively, to facilitate stool passage. Prokinetic agents, such as lubiprostone, enhance intestinal motility by activating chloride channels, leading to increased fluid secretion and improved stool consistency. These treatments are crucial for constipation patients as they address different underlying mechanisms, providing relief from symptoms and improving quality of life.