Bowel Dysfunction

Researchers are evaluating how abdominal massage affects gastrointestinal functions in patients who are mechanically ventilated and receiving enteral nutrition in intensive care units. This study aims to assess abdominal massage's impact on bowel movement frequency, gastric residual volume, and abdominal distension. The trial is designed as a prospective, single-blind randomized controlled trial to provide scientific evidence for abdominal massage use in this patient group. Participants are randomly assigned to either an intervention group receiving abdominal massage or a control group receiving standard care without massage. Abdominal massage is performed twice daily for 15 minutes over three days using specific techniques like effleurage, petrissage, and vibration. The massage is given at the bedside in a semi-Fowler position before enteral feeding, with routine nursing care provided to all patients. Throughout the study, researchers monitor bowel movements, gastric residual volume, abdominal distension, and stool consistency using specialized forms and scales twice daily. Data collection includes clinical assessments such as Glasgow Coma Scale and APACHE II scoring. The study lasts three days for each patient, with detailed recording of gastrointestinal function parameters to evaluate the effects of abdominal massage compared to standard care.

This research aims to compare the safety and effectiveness of two drugs, Ramosetron and Loperamide, for treating Low Anterior Resection Syndrome (LARS), a condition occurring after surgery for mid and low rectal cancer. The study focuses on patients who have undergone surgery and ileostomy repair, assessing improvements in major LARS symptoms. The trial is a multicenter, randomized, and controlled study sponsored by Seoul National University Hospital. Participants will be randomly assigned to receive either Ramosetron or Loperamide. Ramosetron is administered as a drug over a 4-week period. The study uses a quadruple masking design to ensure unbiased results. Both treatments are evaluated over this timeframe to compare their effects on LARS symptoms and patient quality of life. During the study, participants will be assessed at the start and after 4 weeks to measure the severity of major LARS and quality of life using the EORTC QLQ-C30 questionnaire. Researchers will monitor symptom improvement and evaluate safety. The total participation time aligns with these 4-week treatment and assessment periods, focusing on changes in LARS and quality of life scores.

Researchers are evaluating the safety and effectiveness of tenapanor in adults with Chronic Idiopathic Constipation (CIC). This study is a 26-week, multi-center, randomized, double-blind, placebo-controlled trial followed by a 4-week treatment-free safety follow-up period. It aims to compare three different doses of tenapanor with a placebo taken twice daily to assess their impact on constipation symptoms. The study includes a 2-week screening period to confirm eligibility, followed by a 26-week randomized treatment period where patients receive either 5 mg, 25 mg, or 50 mg of tenapanor twice daily, or a matching placebo. Patients record their constipation symptoms daily in an electronic diary. After the treatment period, there is a 4-week safety follow-up without treatment to monitor any adverse effects. Participants will have regular visits every 2 to 6 weeks for safety checks including medical assessments, vital signs, ECG, and lab tests. Their symptom diaries will be reviewed throughout the study. The main outcome measured is the durable complete spontaneous bowel movements response at 12 weeks. Secondary outcomes include changes in bowel movement frequency, stool consistency, and straining. The total study duration is approximately 32 weeks including all phases.

This research aims to evaluate the safety, tolerability, and nutrient absorption of the RELiZORB enzyme cartridge in children aged 2 to 18 years with Short Bowel Syndrome (SBS) who depend on parenteral nutrition (PN). SBS causes inadequate intestinal absorption due to significant loss of small bowel, requiring intravenous nutrition to maintain hydration and nutrition but leading to complications such as liver failure. The study explores whether predigesting fats with RELiZORB can improve absorption and reduce reliance on PN. The RELiZORB device is an enzyme cartridge connected to enteral feeding tubes that mimics pancreatic lipase to digest fats before they enter the gut, aiming to improve fat absorption without the need for bile acid emulsification. Participants will receive tube feeding through the device daily for 90 days. The study monitors changes in PN calories over time, along with growth, fecal fat, plasma fatty acids, and nutrition intake. Participants will be assessed at multiple time points during the 90-day treatment to evaluate PN calorie reduction and nutritional status. Safety and tolerability will be monitored by recording adverse events. The study involves regular clinical visits, laboratory tests, and nutrition assessments to measure the effectiveness of RELiZORB in improving enteral nutrition absorption and supporting growth while reducing PN dependence.

Researchers are evaluating treatments for low anterior resection syndrome (LARS), a condition affecting bowel function after part of the rectum is surgically removed in rectal cancer patients. LARS can cause symptoms like urgency, incontinence, frequent bowel movements, constipation, and incomplete emptying. This trial compares a bowel management program using a retrograde rectal enema (RRE) with standard medical management to determine which approach better manages LARS symptoms. Participants are randomly assigned to one of two groups. One group receives a combination of medical management—including fiber, loperamide hydrochloride, and pelvic floor physical therapy—plus a self-administered RRE enema regimen for one year. The other group receives medical management alone for one year and may be referred for surgery if symptoms persist. Abdominal x-rays may be performed during the trial for participants using the RRE. Throughout the study, participants will be assessed using a validated LARS scoring tool and surveys to measure fecal incontinence and patient satisfaction up to one year after treatment starts. Follow-up visits occur at one month, three months, and one year after completing the intervention. The trial aims to evaluate effectiveness, feasibility, and symptom control of the treatments over this period.

Researchers are evaluating the safety and potential benefits of the Eclipse XL1 System in both children and adults with short bowel syndrome, a condition characterized by having 50% or less of the expected bowel length. This study includes participants aged 3 months to 65 years and is conducted at multiple sites in the United States. The goal is to assess how the device may help with intestinal lengthening and nutritional status. Participants will receive the Eclipse XL1 device, which is placed inside the intestine during a standalone or planned surgical procedure. The device may be inserted once or multiple times depending on medical need, and the location is secured and marked for radiographic monitoring. The study is open label, meaning both participants and doctors know the treatment being given. During the study, participants are monitored while the device is inside their body and again at 3 and 6 months after the device is removed or naturally passes. Researchers will collect data on nutrition, weight, stool, and device position through x-rays. Safety is closely observed by tracking any device or procedure-related adverse events. The total follow-up includes up to 6 months after device removal or passage.

Functional Gastrointestinal Disorders (FGIDs) are conditions marked by long-lasting stomach and digestive symptoms without clear physical causes. They include Irritable Bowel Syndrome (IBS) and Functional Dyspepsia (FD), often linked with ongoing pain, anxiety, and depression. Stress plays a key role by affecting nerve connections between the gut and brain. Researchers are studying Heart Rate Variability (HRV) biofeedback as a way to improve the balance of the nervous system and reduce stress and symptoms in college students with FGIDs. Participants will be randomly assigned to one of two groups: one will receive true HRV biofeedback training, which includes five sessions of 45 minutes each held every two weeks. During these sessions, participants will learn to synchronize their heart rate with their breathing using real-time feedback from ECG and respiratory signals displayed on a screen. The other group will receive placebo training with similar session timing and activities but without feedback based on their own physiological signals. Throughout the study, participants will complete psychological questionnaires and physiological recordings before treatment, after four weeks, and again three months later. Measurements will include anxiety, stress, emotion regulation, IBS severity, and heart rate variability, along with secondary outcomes like emotional state, respiratory rate, and depression. This approach will help assess whether HRV biofeedback reduces stress and gastrointestinal symptoms. The trial involves online screening and follow-up assessments over several months.

This research aims to evaluate the effectiveness of Mosapride Citrate Injection in treating postoperative gastrointestinal dysfunction. The study is a multicenter, randomized, double-blind, parallel, placebo-controlled phase II clinical trial involving adult patients undergoing certain types of intestinal surgery. It seeks to understand how this treatment influences recovery after surgery, focusing on gastrointestinal function. Participants are randomly assigned to one of three groups: one receiving a low dose of Mosapride Citrate Injection (4 mg), another receiving a high dose (8 mg), and a placebo group. Each treatment is given intravenously twice daily for 3 to 5 days. The study has three phases: a screening period up to 28 days before surgery, a treatment period lasting 3 to 5 days after surgery, and a follow-up period of 7 days after the last dose. During the study, participants will be monitored for the time it takes to first pass gas after surgery, which indicates gastrointestinal recovery. Assessments include medical evaluations during screening, treatment monitoring, and follow-up visits. Safety and response to the medication are tracked throughout the study, which concludes approximately 7 days after treatment ends.

Adhesion-related small bowel obstruction (ASBO) is a common digestive emergency that can be treated either conservatively or with surgery. This condition carries a risk of death, especially if surgery is delayed. Researchers are evaluating a procalcitonin-based algorithm to improve decision-making between these treatment options, aiming to enhance patient management and outcomes. The study compares two approaches: one uses clinical examination combined with procalcitonin blood tests to guide treatment decisions, while the other relies on clinical examination alone without procalcitonin testing. Patients in both groups initially receive conservative care including nasogastric tubes and intravenous fluids, with surgery considered after 48 hours if bowel function does not return. The algorithm arm uses specific procalcitonin thresholds to identify patients needing surgery sooner. Participants will be monitored for up to 90 days to see how many achieve a textbook outcome, which reflects quality care. Additional assessments include patient satisfaction questionnaires, complication scores, and length of hospital stay up to 12 months after surgery. The study involves clinical exams, blood tests, and follow-ups to evaluate the impact of the algorithm on treatment timing and patient recovery.

This observational study aims to evaluate the effectiveness of Danning Tablets in relieving dyspepsia symptoms in patients who experience digestive issues such as upper abdominal pain, bloating, loss of appetite, acid reflux, or constipation. It seeks to understand how factors like symptom severity, patient demographics, dosage, and treatment duration influence the tablets' impact. The study is sponsored by Shanghai Hutchison Pharmaceuticals Limited and focuses on patients already using Danning Tablets in their regular care. Participants in this study are adults aged 18 to 75 who are currently taking Danning Tablets for indigestion symptoms as part of their regular treatment. The study involves collecting questionnaire responses at two and four weeks after starting their treatment to assess changes in symptoms and quality of life. There is no control group since this is an observational study of patients already taking the medication. Throughout the study, participants will complete assessments measuring the rate of symptom improvement, including dyspepsia symptom relief, gastrointestinal symptom rating scales, abdominal pain ratings, and quality of life using the EQ-5D-5L questionnaire. Adverse events are also monitored during the two- and four-week periods. The main outcome is the responder rate for dyspepsia symptoms at four weeks after enrollment, with all participation lasting up to four weeks.