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 massages 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.

Children with short bowel syndrome SBS have reduced intestinal length or function, causing poor absorption of nutrients and requiring intravenous nutrition parenteral nutrition, PN to sustain hydration and nutrition. Long-term PN use can lead to serious complications including liver failure. This study evaluates the RELiZORB enzyme cartridge, a device designed to improve fat digestion and absorption by predigesting fats in enteral feeding tubes, potentially reducing the need for PN in children aged 2 to 18 years who are PN dependent. Participants will use the RELiZORB device connected inline with their enteral feeding tubes daily for 90 days. The device mimics pancreatic lipase to digest fats before they enter the intestine, bypassing the need for bile acid emulsification. Tube feeds run across the device to enhance fat absorption. This open-label, single-group trial monitors changes in PN calories, growth, fecal fat, plasma fatty acids, and nutrition intake over the study period. During the study, participants will have assessments at multiple timepoints including days 7, 14, 28, 60, and 90. Researchers will measure effectiveness by changes in PN calorie requirements and weight, monitor safety by tracking adverse events, and evaluate tolerability. The study also involves tracking growth, stool fat content, blood fatty acid levels, and nutrition intake. The total participation duration is 90 days, with regular clinic visits for monitoring and data collection.

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 managementincluding fiber, loperamide hydrochloride, and pelvic floor physical therapyplus 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 investigating the safety and effects of FT1 injections in adults with short bowel syndrome SBS, a condition caused by surgical removal of part of the small intestine. This phase 2 trial compares FT1 to a placebo to understand how well FT1 works and how it behaves in the body. The study uses a crossover design where participants receive both treatments separated by a washout period. Participants receive weekly subcutaneous injections of FT1 or placebo for 5 weeks, followed by at least a 6-week washout period, then switch to the other treatment for another 5 weeks. Each cycles effectiveness is assessed by a 72-hour metabolic balance study, measuring changes in fecal wet weight and other markers. The study is double-blind and randomized to ensure unbiased results. During the study, participants attend clinic visits for assessments including metabolic balance studies, blood tests measuring plasma concentrations and biomarkers, and monitoring for adverse events. Outcomes measured include treatment safety, changes in fecal and urine volumes, and plasma levels of L-citrulline. The total participation period spans approximately 5 months from the first dose to study completion, with close safety monitoring throughout.

Researchers are evaluating the safety and potential benefits of the Eclipse XL1 System in both children and adults who have short bowel syndrome, a condition where part of the small intestine is missing or has been removed. This single-group, open-label clinical study includes participants aged from 3 months to 65 years old and is conducted across multiple sites in the United States to better understand how this device might help with intestinal growth. The study involves placing the Eclipse XL1 device inside the intestine during either a standalone surgery or an already planned procedure. Participants may receive up to two devices simultaneously or undergo multiple procedures if needed. The device is secured inside the intestine and marked with metal clips to monitor its position. Researchers will track how the device affects intestinal lengthening and nutritional status over time, and the device will be observed through imaging until it is removed or naturally passes out. Participants will be monitored while the device is in place and followed up at 3 and 6 months after the device is removed or passes naturally. During the study, their nutrition, weight, and stool will be assessed, and radiographic exams will confirm device placement and safety. Depending on their health, subjects may stay in the hospital or be discharged while participating. The total study duration allows for careful evaluation of device-related adverse events and improvements in intestinal health.

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.