Clinical Research Directory

A Clinical Trial to Examine the Effects of Gut Health Supplements to Improve Gut and Digestive Health and Function

This is a double-blind, randomized, placebo-controlled trial evaluating the efficacy of JSHealth's Debloat \& Detox supplement, used alone or in combination with their Probiotics supplement, on gut and digestive health and function in 60 female participants aged 18-45 with self-reported bloating and digestive discomfort. Participants will be randomly assigned to either the intervention or placebo group for eight weeks. During the first four weeks, intervention participants will take the Debloat \& Detox supplement and placebo participants will take a corresponding placebo. During weeks five through eight, intervention participants will add the Probiotic supplement and placebo participants will add a probiotic placebo. Outcomes will be assessed via study-specific questionnaires and abdominal circumference measurements at Baseline, Day 1 (after first use), and at the end of Weeks 2, 4, 6, and 8.

A Study to Evaluate the Effects of a Supplement on Gut Comfort in GLP-1 Receptor Agonist Users

This is a randomized, triple-blind, placebo-controlled, virtual clinical trial evaluating the effects of the Oxxynea® botanical supplement on gut comfort in adults who use GLP-1 receptor agonists (GLP-1 RAs). Seventy participants experiencing gastrointestinal discomfort associated with GLP-1 RA use will be randomized to receive either Oxxynea® or a matching placebo once daily for six weeks. Participants will complete questionnaires at Baseline, daily for the first 14 days, and at the end of Weeks 2, 4, and 6. The primary measure is change in gastrointestinal comfort assessed by the Gastrointestinal Quality of Life Index (GIQLI). Secondary measures include quality of life, participant-perceived product benefits, and specific GI symptom changes (nausea, abdominal pain, bloating, diarrhea, and constipation).

Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders

This randomized, double-blind, placebo-controlled trial will evaluate the effects of a 14-day course of rifaximin on bloating symptoms, gut microbiota, microbial metabolites, and intestinal gases in adults with Rome V irritable bowel syndrome with constipation (IBS-C) or functional abdominal bloating (FAB). Participants with predominant, bothersome bloating despite adequate bowel movement management will be randomly assigned in a 1:1 ratio to receive rifaximin 550 mg three times daily or matching placebo for 2 weeks. The primary endpoint is the proportion of participants with a bloating response, defined as at least a 1-point reduction from baseline on a 7-point Likert bloating scale at the end of treatment. Additional assessments will include other gastrointestinal symptoms, quality of life, psychological symptoms, gut microbiota diversity and composition, fecal short-chain fatty acids, plasma bile acids and gut-derived uremic toxins, and breath hydrogen and methane levels. Associations between biological changes and clinical response will also be examined.

Effect of Abdominal Massage Training Provided to Caregivers on Constipation Management

Constipation is a common and uncomfortable problem among patients receiving palliative care. Alongside usual treatment and nursing care, abdominal massage may help manage constipation. Teaching caregivers how to perform this massage may also help them feel more confident in supporting the patient. This study aims to evaluate the effects of abdominal massage training for caregivers on patients' constipation, caregiver burden, and caregivers' confidence in contributing to patient self-care. Patients and their primary caregivers will participate together. Both patients and caregivers must be aged 18 years or older. Patients must have constipation, have been hospitalized in a palliative care unit for at least two weeks, and have no clinical condition that prevents abdominal massage. Participants will be randomly assigned to one of two groups. Caregivers in the intervention group will receive a single 45-minute training session that includes an explanation and a practical demonstration of abdominal massage. They will also receive a training booklet. After training, caregivers will perform abdominal massage for 15 minutes in the morning and 15 minutes in the evening, three days per week, for two weeks. Patients will continue receiving their usual treatment and care. Patients and caregivers in the control group will continue with usual treatment and care during the study. Control-group caregivers will be offered abdominal massage training after their study participation is completed. Patients' constipation severity and stool form, as well as caregivers' burden and confidence in contributing to patient self-care, will be assessed at the start of the study and on Days 7 and 14. Ethical approval has been obtained from the University of Health Sciences Hamidiye Ethics Committee for Interventional Research Not Involving Drugs or Medical Devices. Institutional permission has been obtained from the study hospital before data collection. Written informed consent has been obtained from patients and caregivers. Participation is voluntary, and personal information will be kept confidential.

Effect of a Constipation Prevention Checklist in Hip Surgery Patients

Constipation is a common postoperative problem in patients undergoing hip surgery and may be associated with immobilization, opioid analgesic use, and inadequate fluid and fiber intake. Preventive interventions, including adequate fluid and nutritional intake, early mobilization, and abdominal massage, may help maintain bowel function. However, evidence regarding the effectiveness of a standardized checklist to guide and monitor these interventions throughout the perioperative period remains limited. This randomized controlled trial aims to determine the impact of monitoring the risk of perioperative constipation and prevention interventions using a standard checklist on bowel sounds, postoperative constipation severity, and quality of recovery in hip surgery patients. The checklist includes a systematic assessment of constipation risk and monitoring of preventive interventions, including fluid and nutrient intake, early mobilization, and abdominal massage. The findings may contribute to improving perioperative nursing care and constipation prevention in patients undergoing hip surgery.

Multi-strain Probiotic Effects on Self-Reported Constipation

Constipation is a prevalent gastrointestinal condition. Beyond simple lifestyle measures (e.g. increasing fibre intake, hydration, levels of exercise), medical therapies are available for management. However, a sizeable number of sufferers are dissatisfied with drug treatments (either over-the-counter or prescribed), meaning there is an unmet need for alternative therapeutic strategies. Pre, pro- and synbiotics have emerged as one alternative treatment, and a growing body of evidence now supports their use in a proportion of individuals with mild constipation. However, it is currently not possible to predict which individuals may benefit. A better understanding of an individuals' symptoms and underlying pathophysiology may allow for more targeted treatment. The multistrain live bacterial food product (probiotic) being tested contains billions of live and active bacteria that has been shown to improve symptoms in the irritable bowel syndrome (IBS: which is 'constipation-predominant' in many). Notably, improvements ('completely resolved' or 'some positive difference') in bowel habit satisfaction, abdominal pain, bloating and urgency, as well as on quality of life have been shown after 4 or more weeks of this probiotc. This study aims to have 20 participants with self-reported constipation to assess improvements in constipation symptoms, quality of life and measures of gut function.

Oat Milk for Laxation

This study intends to recruit 90-100 constipated participants aged 25-50 years, including an equal number of males and females, from the faculty and logistics staff of Capital Medical University. Participants will be randomly divided into an intervention group (55-60 individuals) and a control group (35-40 individuals). The intervention group will consume 250 mL of Mengniu Daily Fiber Oat Milk daily for 4 weeks, while the control group will not receive oat milk intervention. Both groups will maintain their original lifestyles, including diet, sleep, and exercise, throughout the study period. Baseline surveys, dietary surveys, blood and urine routine tests, blood biochemical indices, and intestinal flora detection will be conducted before and after the intervention. Defecation status will be recorded, and gastrointestinal symptoms will be assessed using a Gastrointestinal Symptom Rating Scale. Statistical analysis will be performed to determine the laxative efficacy of oat milk.

Relationship Between Interoception and Postural Control in Constipation-Predominant Irritable Bowel Syndrome

This cross-sectional, observational, controlled comparative study aims to investigate the relationship between interoception and postural control in individuals with constipation-predominant irritable bowel syndrome (IBS-C) and to compare the findings with those of healthy individuals. Interoception will be assessed using the Multidimensional Assessment of Interoceptive Awareness-2 (MAIA-2), postural characteristics will be evaluated using the Corbin Posture Analysis, and stool type in the IBS-C group will be assessed using the Bristol Stool Scale.

Comparative Research Between Swenson and Soave Operations for Pediatric Patients Who Have Hirschsprung Disease

Hirschsprung's disease is characterized by a lack of enteric nervous system ganglion cells (aganglionosis) in a variable extent of distal bowel. It is the commonest congenital bowel motility disorder and affected neonates usually present with distal intestinal obstruction in the first few days of life. Despite the common underlying pathology of Hirschsprung disease, it has varying presentations. Infants classically present with delayed passage of meconium, feeding intolerance, and bilious emesis. In fact, 90% of children with Hirschsprung will not have passage of stool within the first 24 h of life. Neonates and infants can also present with abdominal distension, failure to thrive, enterocolitis, or bowel perforation. Hirschsprung's disease is characterized by a variable length of distal colonic aganglionosis. In approximately 80% of cases, it is short-segment, and only involves the rectosigmoid colon. Less commonly, it can extend proximal to the sigmoid colon (15%), include the entire colon (total colonic aganglionosis, 5%), or rarely, the entire intestine (total intestinal aganglionosis). The principles of the operation are to remove the aganglionic colon and connect the normally innervated bowel just above the anus, at a level which prevents further functional obstruction, but at the same time preserves fecal continence. The surgical treatment of Hirschsprung's disease has evolved from the historical three-stage procedure to a single-stage technique. Since then, multiple series reported its safety, efficacy, and feasibility in the management of HSCR in the neonatal period. Swenson and Bill, Soave, and Duhamel are the most common procedures for Hirschsprung's disease. However, there is a heated debate about which technique gives the best short- and long-term outcomes. There are many surgical approaches to Hirschsprung's disease, including the transabdominal approach (TAB) and transanal endorectal pull-through (TERPT). The TAB includes 4 types: the Swenson, Duhamel, Rehbein, and Soave procedures. Both the Swenson and the Soave procedures have been adapted as transanal approaches. Transanal access is based on the traditional surgical techniques performed previously in abdominal approach. This type of surgery is used for the treatment of small children. Transanal endorectal pull-through method performed with transanal access is characterized by low invasiveness of surgery and good results of treatment. The Swenson procedure involves the removal of the entire affected site and end-to-end anastomosis of the normal colonic anal canal. In the Soave procedure, physiological saline is injected into the rectum after cutting through the rectal muscle layer in a circular manner, while keeping the mucosa intact to the dentate line level.

A Study to Assess Maternal and Fetal Outcomes After Taking Prucalopride During Pregnancy

This study will collect information on pregnant women diagnosed with constipation from the two large health care insurance claims records. It will include the following groups: * Those who took prucalopride. * Those who took other medicines for constipation. * Those who did not take any prescription medicines for constipation. The main aim of the study is to find out whether the medicine prucalopride, which is used to treat constipation, is safe for use during pregnancy and to look at whether taking prucalopride at certain times during pregnancy is associated to a higher chance of specific health problems for the mother or baby. The study uses two large existing healthcare insurance databases for collecting information. Participants are not enrolled, treated, or required to visit the doctor during this study.

A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)

The purpose of this study is to evaluate how well brenipatide (LY3537031) is tolerated what side effects may occur, and the safety and efficacy in participants with Irritable Bowel Syndrome-Constipation (IBS-C). The study drug will be administered subcutaneously (SC) (under the skin) when compared with placebo. The study will last approximately 36 weeks.

Mixed Natural Prebiotic-Fibers Impact on Stool Frequency and Fecal Microbiota in Constipated Thai Adults

Mixed Natural Prebiotic-Fibers Impact on Stool Frequency and Fecal Microbiota in Constipated Thai Adults: A Randomized Clinical Trial.

The ReVo Study: Low-volume vs High-volume Rectal Irrigation

Rectal irrigation, which is the introduction of warm tap water through the anal canal into the rectum to initiate defaecation, is recommended to be considered in patients with chronic constipation, which is refractory to conservative measures such as lifestyle modification, laxatives, nurse-led bowel retraining programmes which focuses on bio-feedback as well as psychosocial support. Two systems of rectal irrigation are available based on volume delivered, low and high volume. It is unknown if one type of irrigation is superior to the other and whether one type has better outcomes in patients with a particular pathology. Therefore, a comparison is required between the two types of irrigation to assess their acceptability as a therapy and response rates in patients with chronic constipation secondary to difficulty emptying rectum. This trial/research aims to compare low-volume rectal irrigation with high-volume rectal irrigation in patients with chronic constipation secondary to disorders of difficulty emptying rectum. The main questions it aims to answer are: * if one type of rectal irrigation is superior to the other * whether one type of rectal irrigation has better outcomes in patients with a particular pathology on pelvic floor ultrasound * assess the acceptability and response rates to rectal irrigation. Participants upon recruitment will be allocated to either low-volume rectal irrigation or high volume rectal irrigation groups. This will purely be by chance where the possibility of being in either of the groups will be 50%. They will then undergo a baseline assessment with four quality-of-life questionnaires and clinical examination. Following this a pelvic floor ultrasound will be performed to assess the cause of their symptoms. Lastly they will be provided training on using rectal irrigation (the type they have been assigned to). They will then be asked to commence irrigation at home from the next day. Participants will continue to use irrigation for three months and then have a three-monthly follow-up where the quality of life questionnaires will be filled again. This data will then be used to assess any improvement in symptoms after using rectal irrigation. After three months of using rectal irrigation, participation in the trial will come to and end.

Effect of Abdominal Massage on Functional Constipation in Older Adults Living in a Care Center: A Randomized Controlled Trial

Objectives: Although constipation can occur at any age, it is a common and treatable health problem among older adults. This randomized controlled study aimed to investigate the effect of abdominal massage on constipation among older adults receiving care services in a care center. Methods: The study included 86 older adults who met the Rome IV diagnostic criteria for constipation and had no contraindication to abdominal massage. Participants were randomly assigned equally to intervention and control groups using simple randomization. Abdominal massage was administered to the intervention group for 15 minutes per day, five days a week, for four weeks, while no intervention was applied to the control group. Constipation severity and constipation related quality of life were assessed using the Constipation Severity Scale (CSS) and the Patient Assessment of Constipation Quality of Life (PAC-QOL). Conclusions: Abdominal massage may be a non-invasive, low-cost, and easily applicable intervention for managing constipation among older adults. Further randomized controlled trials with longer intervention and follow-up periods are warranted.

Clinical Study of Resistant Starch in Improving Constipation

Constipation is one of the most common gastrointestinal (GI) disorders in clinical practice, with approximately 11-20% of adults worldwide suffering from constipation. Clinically, the frequency of defecation is reduced, or the defecation is laborious, obstructed, difficult, and the stool is dry and difficult to solve, which is called constipation. Clinically, constipation is difficult to treat and over-reliance on laxatives often leads to water and electrolyte imbalance, gastrointestinal dysfunction, melanosis of the colon, relaxation of anal sphincter and other problems, and even leads to colorectal cancer, diabetes, anorexia nervosa and other complications in some cases. Therefore, it is very important to find a safe and effective laxative drug or diet to improve and relieve constipation symptoms. The health promotion effect of resistant starch is mainly due to the short-chain fat and gas produced by microbial fermentation in the colon, and its role in preventing colorectal cancer and some diet-related chronic diseases is stronger than dietary fiber, and it can effectively overcome the adverse odor, rough texture, poor quality and other drawbacks of food fortified with dietary fiber. Ruminococcus bromii is a specific microorganism that degrades resistant starch. The starch decomposing enzyme of R. bromii has a unique tissue structure and forms a multi-enzyme complex. Through the adhesion protein and dockerin module, it is attached to the cell surface through the scaffold protein in the cellulose body. Big data analysis showed that the relative abundance of R. bromii in healthy people was significantly higher than that in patients with constipation. Therefore, the purpose of this clinical trial is to supplement resistant starch to patients with constipation: (1) Observe whether the symptoms of patients with constipation have improved; (2) Analyze the changes of intestinal microorganisms in patients with constipation; and (3) Verify whether the relative abundance of R. bromii is increased and analyze the correlation between the relative abundance of R. bromii in intestine and the improvement of constipation symptoms in patients with constipation.

The Effects of TTNS, TTNS Combined With PHUS, and Conventional Therapy With PHUS in the Treatment of PFC.

This study is a randomized, controlled trial designed to evaluate the effects of transcutaneous tibial nerve stimulation (TTNS), TTNS combined with pocket-sized handheld ultrasound (PHUS), and conventional therapy with PHUS on children with functional constipation (FC). Participants will be stratified into three intervention arms (n=20 per group). FC will be defined based on the Rome IV diagnostic criteria, in the absence of organic or anatomical causes. Participants will be between 4 and 14 years old and will have experienced failure of conservative treatment for at least three months prior to enrollment. The primary outcomes include changes in rectal ultrasound parameters and symptom severity scores. Ultrasound assessments will be conducted by trained clinicians using standardized protocols. Monitoring for adverse events will be performed throughout the intervention phase. Safety considerations include predefined exclusion criteria, such as underlying neurological, metabolic, or cardiac conditions.

A Rapid Clinical Care Pathway to Care for Patients Affected by Chronic Constipation

This research is studying how the availability of a Food and Drug Administration (FDA)-cleared point-of-care, bedside device bedside device called Rectal Expulsion Device (RED) can be used to evaluate constipation in the participants' routine office visit with the participants' care provider. In this research, participants will be asked to complete a survey prior to the gastroenterology office consultation. Health-related information will be collected for this research study. There are no additional study visits for this research study.

Final Examination Stress and Bowel Symptoms

This prospective observational study aims to investigate the association between final examination stress and bowel symptoms in university students. Participants will be evaluated during the final examination period, which represents a naturally occurring period of increased academic stress. Bowel-related symptoms, including constipation-related complaints, defecation-related pain, stool characteristics, and urgency, will be assessed. Participants will also complete a 7-day diary to record bowel characteristics and selected lifestyle factors, including sleep duration, daily step count, and fluid intake. These factors will be examined as potential variables associated with bowel symptoms during the examination period.

Balloon Inflation in Biofeedback

Chronic constipation, particularly due to dyssynergic defecation, is common and impacts quality of life. Biofeedback therapy (BFT) is the most effective conservative treatment, teaching patients to coordinate abdominal and anal muscles during defecation. In standard practice, the rectal balloon used in high-resolution anorectal manometry (HRAM) and biofeedback is left deflated, though some centres inflate it to simulate a more natural urge to defecate. However, the efficacy of this modification has not been validated. This study aims to determine whether performing BFT with the balloon inflated to a patient's defecatory desire volume enhances physiological coordination and patient understanding compared to the standard deflated approach.

Pre-operative Polyethylene Glycol 3350 for Minimally Invasive Urogynecologic Surgery

The goal of this clinical trial is to test the use of a laxative before surgery in women having surgery to fix pelvic prolapse that do not have constipation. The main question it aims to answer is: Does use of a laxative before surgery lessen the discomfort of bowel movements after surgery? Participants will be asked to complete questionnaires before and after surgery. Researchers will compare using the laxative before and after surgery versus only after surgery to see if there is less discomfort with bowel movements after surgery.

Test Anxiety on Bowel Health and Constipation in Students

This observational cross-sectional study aims to examine the relationship between test anxiety, bowel health, and constipation in university students. The study will include undergraduate students aged 18 years and older who are studying in the Physiotherapy and Rehabilitation Department at Lokman Hekim University and who are in their final examination period. Participants will complete self-report questionnaires during a single face-to-face assessment session. Constipation status will be evaluated using the Rome IV criteria, stool form will be assessed using the Bristol Stool Scale, constipation severity will be assessed using the Constipation Severity Instrument, and test anxiety level will be assessed using the Test Anxiety Inventory. Sociodemographic characteristics and bowel-related symptoms will also be recorded. The study does not include any intervention or treatment. The findings are expected to help better understand whether test anxiety during examination periods is associated with bowel health problems and constipation in university students.

A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Disease

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

Investigation of the Additional Effects of Aerobic Exercise Training to Abdominal Massage in Functional Constipation

The aim of this study was to investigate the additional effects of aerobic exercise to abdominal massage in patients with functional constipation. There are several studies investigating the effects of massage and aerobic exercise separately in functional constipation. However, to the best of our knowledge, there are no studies combining abdominal massage and aerobic exercise to demonstrate additional effects. By combining these two approaches, we believe that a higher and broader effect (local and systemic) and perhaps a cure for constipation (reaching the ideal defecation frequency or asymptomatic status) can be achieved. Therefore, this study will include individuals between the ages of 18-65 who have a diagnosis of functional constipation and who agree to participate in the study. This study is designed as a randomized controlled trial.

Guideline to Implementation: A Rapid Clinical Care Pathway to Care for Patients Affected by Chronic Constipation

The study is being completed to test the pilot implementation of a rapid clinical care pathway for chronic constipation in the University of Michigan Gastroenterology clinic. This study will learn how often patients get better and how satisfied patients are with care decisions, when seen by a gastroenterologist for medical advice on constipation.