Gastrointestinal Toxicity

Researchers are evaluating the effectiveness of low volume Transanal Irrigation TAI using the Qufora IrriSedo MiniGo device combined with standard conservative treatments compared to conservative treatment alone for patients with Low Anterior Resection Syndrome LARS. This condition affects individuals who have undergone surgery for rectal cancer. The study aims to assess improvements in clinical symptoms of LARS over a three-month period. Participants are divided into two groups one receiving low volume TAI with the MiniGo device plus standard conservative care, which includes dietary management, counseling, and prescribed medications excluding suppositories and physiotherapy and another group receiving only the standard conservative treatments. The study includes follow-ups at 6 weeks, 3 months, and up to 12 months to monitor various outcomes. During the study, participants will be regularly assessed using the LARS score to measure symptom changes, quality of life questionnaires EORTC QLQ-C30 and QLQ-CR29, incontinence scores, patient satisfaction, treatment compliance, bowel management time, and healthcare resource usage. Data will be collected at multiple intervals including 6 weeks, 3 months, 6 months, 9 months, and 12 months to thoroughly evaluate the treatment impact and patient preferences.

Researchers are evaluating the impact of regular use of a consumer-grade FODMAP-targeting digestive enzyme blend called FODZYME on gastrointestinal symptoms in adults who experience self-reported bloating. The study focuses on how this enzyme blend affects symptoms such as bloating and abdominal pain, which are often triggered by fermentable carbohydrates known as FODMAPs. This is a randomized, double-blind, placebo-controlled crossover trial that aims to provide a more flexible alternative to the restrictive Low FODMAP Diet by breaking down FODMAPs before they ferment in the colon. Participants will take the enzyme blend or a placebo with each meal, snack, or substantial beverage, applying it directly to their food. The trial is divided into two main periods half the participants will start with the enzyme blend for four weeks followed by a two-week washout and then switch to placebo for another four weeks the other half start with placebo and then switch to the enzyme blend after the washout. The study product is designed to target specific FODMAPs like fructan, GOS, and lactose and is intended for adults with or without IBS symptoms. During the study, participants will complete daily questionnaires and assessments over about 19 weeks, including patient-reported outcome measures for bloating, gastrointestinal symptoms, abdominal pain, food-related quality of life, and anxiety. The study is conducted remotely, allowing participants to complete assessments at home using a smartphone app. Safety is monitored by excluding those with known allergies to corn or previous reactions to digestive enzyme supplements, and researchers will review changes in bloating symptoms as the primary outcome.

This trial is focused on adults with cancer who are receiving chemotherapy and experience nausea and vomiting as side effects. Researchers are studying a drug called LY3537021 to see how well it controls these symptoms and to evaluate its safety. The study is a Phase 2, double-blind, placebo-controlled trial designed to better understand the treatment options for chemotherapy-induced nausea and vomiting in this population. Participants are randomly assigned to receive either LY3537021 or a placebo, both given as a subcutaneous injection before chemotherapy. All participants also receive standard anti-nausea treatments, which may be taken orally, intravenously, or through skin patches. The chemotherapy drugs involved include cisplatin or an anthracycline and cyclophosphamide combination. The study treatment is given prior to chemotherapy, and the trial lasts about two months per participant. During the study, participants will be monitored for nausea and vomiting from the time of their chemotherapy infusion through up to five days afterward. Researchers will collect data on symptom control, the need for rescue medications, and drug levels in the body. Participants will complete diaries to track nausea severity. Safety and response to treatment are carefully observed. The study aims to measure how many participants have a complete response to nausea and vomiting during the delayed phase after chemotherapy.

Researchers are evaluating the effects of a butyrate and polyphenol formulation on gut health and related symptoms in healthy adults aged 25 to 70 who experience moderate to severe gastrointestinal discomfort. The study aims to understand how this formulation affects the gut microbiome and gastrointestinal symptoms using questionnaires and lab assessments. This is a double-blind, randomized, placebo-controlled study sponsored by Supplement Formulators, Inc. Participants will be randomly assigned to receive either the butyrate plus polyphenol formulation or a placebo. The treatment period lasts 14 days, during which participants take the assigned supplement. The study includes laboratory testing to assess the gut microbiome and various questionnaires to evaluate gastrointestinal symptoms and quality of life. During the study, participants will complete laboratory assessments and several questionnaires, including the Gastrointestinal Symptom Rating Scale for Irritable Bowel Syndrome, digestion-related quality of life surveys, and stool form scales. Researchers will monitor changes in gut microbiome composition and gastrointestinal symptoms over the 14-day period. The study also tracks safety and symptom improvement through standardized scales and quality of life measures.

Researchers are evaluating the effects of Tradipitant on treating nausea and vomiting caused by GLP-1 receptor agonist use in adults who are overweight or have class I or II obesity. This phase 3, randomized, placebo-controlled study includes healthy volunteers without serious medical issues or diabetes. The goal is to better understand how Tradipitant impacts these symptoms compared to a placebo. Participants will be randomly assigned to receive either Tradipitant or a placebo, both given as oral capsules twice daily for about two weeks. The study has two treatment arms one receiving Tradipitant and the other receiving a placebo. The study uses quadruple masking to ensure unbiased results. During the study, participants will record nausea and vomiting symptoms daily in a symptom diary. Researchers will measure the proportion of participants experiencing vomiting episodes and assess nausea severity over one week. The study will monitor safety and side effects throughout, with the total participation duration around two weeks of treatment.

Researchers are studying nutritional support strategies for critically ill patients with impaired gastrointestinal function, focusing on how to best achieve energy and protein intake goals. The study investigates the use of enteral nutrition alone versus a combination of enteral nutrition and supplemental parenteral nutrition SPN in patients who have impaired gastric emptying and reduced intestinal absorption. This research addresses the challenge of feeding intolerance and malnutrition in intensive care patients and explores muscle mass and function as important factors in nutrition efficacy. The study randomly assigns patients with diagnosed gastrointestinal dysfunction to one of two groups one receiving gradual increases in enteral nutrition based on tolerance, and the other receiving a mix of enteral trophic feeding plus SPN to meet nutritional targets. Nutritional needs are monitored daily by indirect calorimetry, and gastrointestinal function is assessed with ultrasound gastric residual volume and a paracetamol absorption test. The SPN group aims to reach 80% of nutritional goals by day five, while the enteral nutrition group aims for full caloric intake as tolerated. Participants are monitored through various evaluations including muscle thickness via ultrasound, lean body mass by bioelectrical impedance analysis, and muscle strength with a handgrip dynamometer at admission and on days 10 and 15. The study measures daily calorie and protein intake adequacy, metabolic markers, and clinical outcomes such as mortality up to 28 days. Nutritional status, muscle function, and energy utilization are carefully assessed throughout the study to understand the impact of the tailored feeding protocols.

Researchers are evaluating adjuvant chemotherapy for patients with stage III gastric cancer who have undergone D2 gastrectomy and achieved R0 resection. This phase 3, open-label, randomized study compares the effects of oxaliplatin plus S-1 versus docetaxel plus S-1 on disease-free survival. The study aims to provide direct comparison of these two chemotherapy regimens, focusing on their safety profiles, treatment duration, and patient adherence. Participants are randomly assigned to one of two treatment groups. The first group receives eight 3-week cycles of intravenous oxaliplatin with oral S-1 doses adjusted by body surface area. The second group receives oral S-1 for the first cycle, followed by six cycles of intravenous docetaxel plus oral S-1, and then continues oral S-1 for up to one year. The treatments are given after surgery, and the study includes follow-up for five years. During the study, participants undergo monitoring for disease recurrence and overall survival, along with safety assessments over approximately six months of treatment. The main outcome measured is the 3-year disease-free survival rate, with secondary outcomes including 5-year overall survival, safety profiles, and recurrence sites. The study will track patients closely with regular evaluations throughout the treatment and follow-up periods.

This research aims to understand the training experience of senior general surgery residents in advanced gastrointestinal GI surgical procedures during residency. It focuses on identifying who provides this training and assessing residents self-reported comfort and competence in performing both common and complex GI surgeries. The study highlights the importance of evaluating the need and interest in an Advanced GI Surgical fellowship among senior residents as they consider further specialized training or beginning independent practice. Participants include fourth and fifth year general surgery residents in accredited residency programs across the United States. The study collects data through an anonymous survey about their training in advanced GI procedures and their comfort level with managing GI surgical pathologies. This observational study does not involve any medical interventions or treatments. Throughout the study, participants complete surveys that assess their training experiences and confidence in GI surgical skills. Researchers analyze these responses to better understand educational gaps and fellowship needs. The primary outcome is focused on the training of senior general surgical residents over one year. Participation involves completing the survey without any active treatment or procedures, and the study is conducted anonymously to ensure privacy.

This research aims to evaluate the effects of a one-week alternate nostril breathing ANB exercise on the severity of nausea and vomiting in pregnant individuals during their first trimester. The study involves a prospective, two-arm, non-blinded randomized controlled design to compare this breathing practice against usual care. It focuses on pregnant participants experiencing mild to moderate nausea and vomiting during early pregnancy. Participants in the intervention group will learn the ANB technique through a brief orientation, followed by written and video instructions. They will perform ANB three times daily for 5 to 10 minutes over seven days, starting the day after enrollment. The control group will continue with usual care without the breathing exercises but will also complete daily symptom diaries during the same period. During the study, all participants will record their nausea and vomiting symptoms daily using a symptom diary. Researchers will assess the primary outcome by measuring the severity of nausea and vomiting on day seven. The study will monitor participants over the 7-day intervention period, with data collected to evaluate the breathing exercises impact on symptoms.

Researchers are studying gut and digestive health by evaluating changes before and after using a dietary supplement system for eight weeks. This study focuses on adults aged 18 to 80 years who have self-reported gastrointestinal symptoms. The goal is to understand how the supplement affects gut microbiota, inflammation, immune activity, and digestive function, which are important for overall health and well-being. Participants will take a dietary supplement system consisting of two products, PhytoPower 1 and PhytoPower 2, daily for eight weeks. They will mix one stick pack of each product into 16 fluid ounces of water and drink it each morning, with or without food. The study is open-label and single-arm, meaning all participants receive the supplement while maintaining their usual diet and lifestyle. During the study, participants will provide stool samples at the beginning and end to measure various biomarkers related to gut microbial diversity, inflammation, immune activity, digestion, and intestinal barrier integrity. They will also complete questionnaires about gastrointestinal symptoms and digestive well-being at several points throughout the study. Safety and tolerability will be monitored by tracking adverse events and compliance, with the total participation lasting eight weeks.