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New treatment option for Constipation
Official title Understanding Mechanisms of Normal and Disordered Defecation
ClinicalTrials.gov ID: NCT03842007
What this study is testing
- What it's testing
- Researchers are trying to better understand why constipation occurs and improve the tests for diagnosing these conditions.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80. Healthy volunteers may be eligible.
You may be able to join if
- Male and female volunteers aged 18-80 years.
- Able to provide written informed consent before participating in the study.
- Able to communicate adequately with the investigator and to comply with the requirements for the entire study.
- Individuals with chronic constipation for 1 year, with 2 or more of the following symptoms for 3 months or longer: \<3 bowel motions/week, straining...
- Able to provide written informed consent before participating in the study.
You likely can't join if
- Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other...
- Current symptoms of a functional gastrointestinal disorder assessed by questionnaire.
- Putative risk factors for pelvic floor trauma: i.e. six or more vaginal deliveries, birthweight \>4500gms (macrosomia), or known 3rd or 4th degree...
- Medications that are likely to alter gastrointestinal motility: e.g., opiates and anticholinergic medications; a stable dose of thyroxine and low...
- Active rectal inflammation, cancer; perianal sepsis; history of pelvic radiation, rectosigmoid surgery or inflammatory bowel disease.\
- Anxiety or depression as assessed by the Hospital Anxiety and Depression Questionnaire.
See the full eligibility criteria
- Male and female volunteers aged 18-80 years.
- Able to provide written informed consent before participating in the study.
- Able to communicate adequately with the investigator and to comply with the requirements for the entire study.
- Individuals with chronic constipation for 1 year, with 2 or more of the following symptoms for 3 months or longer: \<3 bowel motions/week, straining ≥ 25% of time, hard or lumpy stools ≥ 25% of time, anal digitation ≥...
- Able to provide written informed consent before participating in the study.
- Able to communicate adequately with the investigator and to comply with the requirements for the entire study.
- Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study and/or pose...
- Current symptoms of a functional gastrointestinal disorder assessed by questionnaire.
- Putative risk factors for pelvic floor trauma: i.e. six or more vaginal deliveries, birthweight \>4500gms (macrosomia), or known 3rd or 4th degree perineal tear.
- Medications that are likely to alter gastrointestinal motility: e.g., opiates and anticholinergic medications; a stable dose of thyroxine and low doses of tricyclic agents (e.g., up to amitriptyline (50 mg daily).
- Active rectal inflammation, cancer; perianal sepsis; history of pelvic radiation, rectosigmoid surgery or inflammatory bowel disease.\
- Anxiety or depression as assessed by the Hospital Anxiety and Depression Questionnaire.
- Pregnant women, prisoners and institutionalized individuals.
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.