Diagnostic Tests for Gut Transit in Constipation

Overseen by Adil Bharucha, MBBS, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Mayo Clinic

Must not be taking: Opiates, Anticholinergics

Disqualifiers: Cardiovascular, Respiratory, Renal, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the treatment Fecoflowmetry for constipation?

Fecoflowmetry is a new technique that helps differentiate between normal and constipated individuals by analyzing fecal flow rates. It can identify different types of constipation, such as obstructive and inertia types, making it a useful tool for understanding and managing constipation. ^{1 2 3 4 5}

Is Fecoflowmetry safe for humans?

Fecoflowmetry is described as a simple, non-invasive, and non-radiologic technique, which suggests it is generally safe for humans. ^{1 4 5 6 7}

How does this treatment for constipation differ from other treatments?

This treatment is unique because it uses diagnostic tests like colonic and anorectal manometry to understand the specific causes of constipation, allowing for a more tailored approach to treatment. Unlike standard treatments that may not address the underlying issues, these tests provide detailed insights into the function of the colon and rectum, helping to identify specific problems such as slow transit constipation or dyssynergic defecation. ^{5 6 8 9 10}

Research Team

Adil Bharucha, MBBS, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

I am between 18 and 80 years old.

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.

Trial Timeline

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

Treatment Details

Interventions

• Fecoflowmetry (Diagnostic Test)
• Rectal Barostat Study (Diagnostic Test)

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.

Participant Groups

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+

Dr. Gianrico Farrugia

Mayo Clinic

Chief Executive Officer since 2019

MD from University of Malta Medical School

Dr. Richard Afable

Mayo Clinic

Chief Medical Officer

MD from Loyola Stritch School of Medicine

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Dr. Griffin P. Rodgers

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

Chief Executive Officer since 2007

MD, M.A.C.P.

Dr. Griffin P. Rodgers

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

Chief Medical Officer since 2007

MD, M.A.C.P.

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Fecoflowmetry: a new parameter assessing rectal function. [2009]

2. Germany pubmed.ncbi.nlm.nih.gov

[Defecation flowmetry. A new study technique for evaluating the evacuation function of the rectum]. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

[Terminal constipation: priority for anorectal manometry]. [2009]

4. United States pubmed.ncbi.nlm.nih.gov

Fecoflowmetry: a new parameter assessing rectal function in normal and constipated subjects. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Clinical utility of colonic and anorectal manometry in chronic constipation. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Anorectal functional testing: review of collective experience. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Fecoflowmetric evaluation of anorectal function and ability to defecate in children with idiopathic chronic constipation. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Manometric evaluation of constipation--Part I. [2005]

9. England 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. [2022]

10. Korea (South) pubmed.ncbi.nlm.nih.gov

Relevance of Colonic Gas Analysis and Transit Study in Patients With Chronic Constipation. [2020]