Constipation clinical trials at UCSD
3 research studies open to eligible people
open to eligible people ages 21-75
Chronic constipation (CC) is a common condition that affects up to 25% of the population in North America. It poses a major burden on the healthcare cost. The pathophysiology of this condition is poorly understood and consequently there are inadequate treatments. Current diagnostic tests provide incomplete and often conflicting information. Fecobionics is an electronic simulated stool that has the consistency and shape of normal stool. The device records pressures, cross-sectional area, orientation, bending, and shape of the rectum and anal canal simultaneously. The central hypothesis is that rectal peristalsis is a key component of the defecatory reflex which is not assessed in the current paradigm of diagnostic testing. The novel Fecobionics device will mimic the natural defecation and provide new mechanistic insights into the anorectal physiology and pathophysiology to facilitate the development of new treatments for CC. The Specific Aims are as follows: 1) Study the defecation dynamics in normal control subjects using Fecobionics. The investigators will establish the role of rectal contraction/peristalsis in the normal evacuation process. 2) Define the defecatory patterns in patients with CC associated with defecatory disorders. The investigators will determine if abnormalities of rectal contraction contribute to the CC. 3) Use a mathematical model of anorectal passage of Fecobionics for enhanced understanding of the normal and abnormal defecatory patterns, including the length-tension properties of the rectum and anal sphincter muscles. The proposal seeks to shift current CC research by providing a stool surrogate for examining the physiologic parameters of defecation reflex using a novel device that will record, pressure, deformability, biomechanics, vectoral and topographic changes in the rectum and anal canal. The noted parameters will be recorded using a wireless Fecobionics device that can examine in detail the mechanistic underpinnings (stress and deformation) of defecation reflex/process in health and disease. The impact of this project is that it assesses a novel, safe, low cost, less invasive, low-risk, radiation-free device in its ability to provide better understanding of evacuation and continence mechanisms and thereby facilitate future development of innovative therapies. The improvement can lead to improvement in diagnostic and therapeutic modalities and reduce healthcare costs associated with anorectal disorders.
La Jolla, California
open to eligible females ages 18 years and up
Prucalopride is a medicine used to treat constipation. The main aim of the study is to measure prucalopride concentrations in breast milk. Other aims are to check the growth and development of babies breastfed by their mothers who took prucalopride and to check if the babies had any side effects. During the study, participants will provide one set of milk samples over 24 hours using an electric breast pump. Breast milk samples will be collected at home and will be shipped to the laboratory. Also, participants will be asked questions during telephone interviews every 2 months in the first year of their baby's life. They will also be asked to complete growth and development questionnaires about their baby.
La Jolla, California
open to eligible females
This study collects information on pregnant women with ongoing constipation who took prucalopride and those who did not take prucalopride. The main aim of the study is to learn if any medical problems in pregnant women or their infants might be related to taking prucalopride during pregnancy. Participants are not required to take prucalopride during the study. The study is non-interventional. Women and their infants are followed during pregnancy and for 1 year after pregnancy to collect information on maternal, pregnancy, and infant outcomes. During the study, participants will be asked questions during 3 telephone interviews; 2 during pregnancy and 1 just after their expected delivery date. Participants who took or are taking prucalopride will be asked more detailed questions about this during these interviews. All information is collected remotely, and no visits to the study site are required. Also, all participants will be asked to complete a questionnaire about their baby when their baby is about 1 year old.
La Jolla, California