Diagnostic Tests for Gut Transit in Constipation

Overseen By Kelly J Feuerhak

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Opiates, Anticholinergics

Disqualifiers: Cardiovascular, Respiratory, Renal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand the causes of constipation and improve its diagnosis. It includes two tests: fecoflowmetry, which measures intestinal flow, and a rectal barostat study, which assesses rectal response to pressure. The trial compares results from healthy individuals with those from people experiencing chronic constipation. Individuals who have had constipation for at least a year and experience symptoms like infrequent bowel movements or straining may be suitable for this study. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could enhance diagnostic methods for constipation.

Will I have to stop taking my current medications?

The trial excludes people taking medications that affect gut movement, like opiates and anticholinergics. If you're on a stable dose of thyroxine or low doses of tricyclic antidepressants, you might still be eligible. It's best to discuss your specific medications with the trial team.

What prior data suggests that these diagnostic tests are safe for assessing gut transit in constipation?

Research has shown that fecoflowmetry and rectal barostat studies are safe methods for assessing rectal function and sensation. Fecoflowmetry, a new technique, examines stool movement through the rectum. The absence of specific data on side effects suggests it is generally well-tolerated.

Rectal barostat studies involve gently inflating a small balloon in the rectum to assess its reaction and sensation. Research indicates this procedure is safe and provides consistent results without causing harm. Studies have not reported any major safety issues.

Both methods continue to be researched, but current evidence suggests they are safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new diagnostic methods like fecoflowmetry and the rectal barostat study for understanding gut transit issues in constipation. Unlike traditional diagnostic approaches, these methods offer a more detailed analysis of how the rectum and anus function during bowel movements. This could lead to more tailored treatments for individuals by pinpointing the root causes of constipation, potentially improving patient outcomes and comfort.

What evidence suggests that these diagnostic tests are effective for constipation?

In this trial, participants will undergo two diagnostic tests: fecoflowmetry and the rectal barostat study. Research has shown that fecoflowmetry assesses bowel function by measuring how the colon handles fluids. This method is useful for understanding constipation and tracking improvements in bowel function. Studies have demonstrated that it provides valuable information on gut function, which can help tailor treatments for constipation.

For the rectal barostat study, research suggests it identifies rectal sensitivity to pressure, which is important for understanding constipation symptoms. By measuring these sensations, it helps determine the causes of constipation and how to address them. Both methods aim to provide doctors with better tools to understand and treat constipation effectively. Participants in this trial will be divided into two groups: healthy individuals and constipated individuals, each undergoing both diagnostic tests. ^{6 7 8 9 10}

Who Is on the Research Team?

Adil Bharucha, MBBS, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have had chronic constipation for a year with at least two symptoms for 3 months.

I can communicate well and follow study instructions.

Able to provide written informed consent before participating in the study

Exclusion Criteria

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

I have been diagnosed with anxiety or depression.

I do not have major health issues that could affect the study or my safety.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit

1 visit (in-person)

Study Day

Participants undergo procedures including rectal barostat study and fecomanoflowmetry to measure rectal and anal pressures, and rectal sensation.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any immediate adverse effects following the study procedures.

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Fecoflowmetry
• Rectal Barostat Study

Trial Overview 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.

How Is the Trial Designed?

Group I: Healthy Individuals Active Control 2 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 Individuals Active Control 2 Interventions

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

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

Anorectal function tests, including anorectal manometry and defecography, have become essential tools for diagnosing and understanding defecation disorders like constipation, which is a complex condition requiring multiple assessment methods.

Despite the advancements in these diagnostic techniques, there is a lack of uniform criteria for identifying manometric abnormalities, highlighting the need for international standards to improve diagnosis and treatment of constipation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Manometric evaluation of constipation--Part I. Rao, SS.[2005]

High resolution total colonic intracavitary manometry (HRCM) demonstrated a higher diagnostic accuracy for functional constipation (FC) at 81.0% compared to 69.6% for the colonic transit test (CTT) in a study of 79 patients.

HRCM also had a lower false negative ratio of 19.0% compared to 30.4% for CTT, indicating that HRCM may be a more reliable method for diagnosing FC, although both tests are important for comprehensive assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A descriptive study of high resolution total colonic intracavitary manometry and colonic transit test in the diagnostic efficacy of functional constipation in Chinese patients. Wang, D., Zhang, Z., Li, M., et al.[2022]

In a study of 145 patients with chronic constipation, there was no overall correlation between gas volume score (GVS) and colon transit time (CTT), indicating that GVS may not be a reliable standalone diagnostic tool for assessing CTT.

However, the study found that a higher total colon GVS was associated with longer CTT (≥ 45 hours), suggesting that GVS could potentially help predict slow transit in chronic constipation cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relevance of Colonic Gas Analysis and Transit Study in Patients With Chronic Constipation. Park, SY., Park, HB., Lee, JM., et al.[2020]

In a study of nine children with idiopathic chronic constipation (ICC), those who exhibited periodic rectal contractions during saline infusion were able to achieve comfortable spontaneous defecation over follow-up periods of 5 to 20 months, indicating a positive relationship between anorectal motility and clinical outcomes.

Fecoflowmetry, a non-invasive technique used to assess anorectal function, revealed that most patients had significantly lower flow rates and longer evacuation times compared to controls, suggesting that disturbances in anorectal motility may contribute to severe cases of ICC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecoflowmetric evaluation of anorectal function and ability to defecate in children with idiopathic chronic constipation. Kayaba, H., Hebiguchi, T., Yoshino, H., et al.[2018]

Fecoflowmetry is a new, non-invasive technique that measures fecal flow rates during defecation, providing both quantitative and qualitative data on the process, which can help assess rectal disorders.

In a study involving 36 normal volunteers and 8 chronically constipated patients, this method successfully recorded various parameters of defecation, making it a useful screening tool for evaluating defecation issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecoflowmetry: a new parameter assessing rectal function. Shafik, A., Abdel Moneim, K.[2009]

Fecoflowmetry is a new, noninvasive technique that measures fecal flow rates and can differentiate between normal defecation and constipation in patients, providing valuable quantitative and qualitative data.

In constipated patients, fecoflowmetry identified two distinct patterns of constipation—nonobstructive (inertia) and obstructive—each with different flow characteristics, which can help tailor treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecoflowmetry: a new parameter assessing rectal function in normal and constipated subjects. Shafik, A., Abdel-Moneim, K.[2019]

In a study of 78 patients with chronic constipation, significant differences in rectal evacuation function were found between those with obstructive defecation disorders and those with slow transit constipation, indicating that the type of constipation affects evacuation dynamics.

Defecoflowmetry proved to be an effective tool for classifying chronic constipation, revealing distinct subgroups within obstructive defecation disorders based on their defecation times and evacuation success, which can help tailor treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Defecation flowmetry. A new study technique for evaluating the evacuation function of the rectum]. Athanasiadis, S., Köhler, A., Weyand, G., et al.[2019]

Anorectal manometry is more effective than colonic transit time measurement in distinguishing terminal constipation from other types, providing valuable insights into the underlying mechanisms.

Once organic causes are ruled out through colonoscopy, anorectal manometry is recommended as the preferred diagnostic tool for terminal constipation, enabling targeted treatment through biofeedback.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Terminal constipation: priority for anorectal manometry]. Dederding, JP., Baumann, R., Fouillet, P., et al.[2009]

Colonic and anorectal manometry techniques are essential for diagnosing different types of constipation, such as slow transit constipation and dyssynergic defecation, by evaluating sensorimotor function in the digestive system.

Understanding the underlying pathophysiology of constipation through these manometric assessments can lead to better management strategies, highlighting the importance of tailored treatments based on individual diagnoses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical utility of colonic and anorectal manometry in chronic constipation. Rao, SS., Singh, S.[2022]

Anorectal manometry is a valuable diagnostic tool for assessing fecal incontinence and constipation, utilizing specific tests like resting anal canal pressure and the rectoanal inhibitory reflex to identify underlying pathophysiological mechanisms.

Despite its utility, the effectiveness of anorectal manometry is limited by a lack of standardized testing protocols and normative data from healthy individuals, which complicates the interpretation of results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anorectal functional testing: review of collective experience. Azpiroz, F., Enck, P., Whitehead, WE.[2022]

Citations

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Outcomes and prognostic factors of fecal microbiota ... This study suggested FMT was effective and safe for STC, while a late loss of efficacy was also observed. A lower degree of sensation of ...

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Does clinical score accurately support fecoflowmetry as a ... FFM evaluates the bowel function by measuring the following parameters: the tolerance rate of intended normal saline solution in the colorectum (TR), the ...

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Effect of fecal microbiota transplantation in patients with slow ... The results show that symptoms of patients with STC were significantly improved after FMT compared with the baseline (Table 2). After treatment ...

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Fecoflowmetry: a new parameter assessing rectal function Fecoflowmetry is a new technique by which the fecal flow rate is studied through recorded curves representing the changes which occur in the rate against time.

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Fecoflowmetry: a new parameter assessing rectal function ... Fecoflowmetry is a new technique by which the fecal flow rate is studied through recorded curves representing the changes that occur in the flow against time.

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The Efficacy and Safety of Fecal Microbiota Transplantation ... This study aims to assess the effectiveness and safety of fecal microbiota transplantation (FMT) combined with biofeedback for patients with mixed constipation.

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Fecal Incontinence and Constipation Questionnaire The FICQ is a self-report questionnaire that consists of 20 items: 15 items related to bowel leakage problems and 5 items related to constipation problems.