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.

Researchers are evaluating LY3537021 to see how well it controls nausea and vomiting caused by chemotherapy in adults with cancer. This phase 2, double-blind, placebo-controlled study aims to assess both the effectiveness and safety of LY3537021 when added to standard antiemetic treatments. Participants are adults who have not previously received chemotherapy and are planned to receive specific chemotherapy drugs. Before chemotherapy, participants receive either LY3537021 or a placebo, both given as a subcutaneous injection. Alongside this, they receive standard of care antiemetic therapies, which may be given orally, intravenously, or through the skin. The chemotherapy drugs used include cisplatin or anthracycline and cyclophosphamide, administered intravenously. The study includes a randomized assignment to one of the two treatment groups and is expected to last about two months for each participant. Participants will be monitored for nausea and vomiting responses up to 120 hours after chemotherapy infusion. Researchers will collect data on complete response rates, nausea levels, and medication use. Pharmacokinetics of LY3537021 will also be assessed during the treatment cycles. Safety will be monitored throughout the study, and participants will be involved until all study parts are completed, with various assessments done at regular intervals.

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 who teaches gastrointestinal (GI) surgical procedures to senior general surgery residents during their training and to assess the residents' comfort level with performing both common and complex GI procedures. It also seeks to explore the need and interest for an Advanced Surgical GI fellowship among these senior residents. The study is observational and focuses on fourth and fifth year general surgery residents in accredited programs in the United States. The study involves an anonymous survey to collect information about the training sources for advanced GI surgical procedures and how confident senior surgical residents feel in performing these procedures after residency. There are no experimental treatments; instead, the survey gathers data regarding training experiences and residents' self-reported competence. The survey aims to provide insights into residency training and fellowship interest over a one-year period. Participants will complete the anonymous survey, sharing their experiences and comfort levels with GI surgery training. Researchers will analyze this information to better understand training adequacy and fellowship needs. The primary outcome measure is the training of senior general surgical residents over one year. No medical procedures or interventions are performed as part of this study, and participation involves only survey completion.

Researchers are evaluating whether the widely available artificial intelligence platform ChatGPT can accurately identify abnormalities on cytology specimens taken during endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) of solid mass lesions in the gastrointestinal tract. The study compares AI interpretations with those made by experienced cytopathologists, who are considered the gold standard. The research aims to address the limited availability of onsite cytopathology services that currently affect diagnostic accuracy and efficiency. The study involves the use of EUS-guided fine needle biopsy to collect cytology specimens from solid mass lesions in the gastrointestinal tract. There are two interpretation groups: one where cytopathologists review specimens onsite, and another where the AI program analyzes the samples. The study observes and compares diagnostic accuracy between these two methods without intervening in patient care. Participants will undergo the biopsy procedure, and their cytology specimens will be evaluated either by onsite cytopathologists or by the AI program. Researchers will measure the diagnostic accuracy at rapid onsite evaluation within one day and compare it to final pathology results obtained within seven days. The study is observational and will monitor these outcomes without additional treatment, lasting until October 2027.

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 exercise's impact on symptoms.