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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
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 moreAwards & 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
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.
Find a Location
Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,429 Previous Clinical Trials
4,322,624 Total Patients Enrolled
9 Trials studying Constipation
17,025 Patients Enrolled for Constipation
Mayo ClinicLead Sponsor
3,316 Previous Clinical Trials
2,954,311 Total Patients Enrolled
14 Trials studying Constipation
469 Patients Enrolled for Constipation
Adil E Bharucha, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
150 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have no active rectal issues, past major rectal surgeries, or inflammatory bowel disease.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 have been diagnosed with anxiety or depression.I do not have major health issues that could affect the study or my safety.I am between 18 and 80 years old.You have had six or more vaginal deliveries, a baby weighing more than 4500 grams (macrosomia), or a severe tear in the perineal area during childbirth.I am not on high doses of medications that affect stomach movement, except for stable thyroid medication or low-dose antidepressants.I am experiencing symptoms of a stomach or bowel problem.
Research Study Groups:
This trial has the following groups:- Group 1: Healthy Individuals
- Group 2: Constipated Individuals
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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