Esophagitis

Researchers are evaluating a magnetic-assisted surgical technique for revisional bariatric surgery, specifically converting sleeve gastrectomy to Roux-en-Y gastric bypass (RYGB) combined with hiatoplasty. This approach addresses long-term problems such as gastroesophageal reflux disease (GERD) in patients who have undergone laparoscopic gastric sleeve (LGS) surgery. The study aims to assess the surgical procedure and its outcomes in patients who are candidates for bariatric surgery with obesity. The surgery is performed using magnetic assistance to improve visualization and manipulation during key steps. It involves placing a single port in the umbilicus and an additional trocar, using magnets for liver retraction, dividing the omentum, repairing hiatal hernia, creating the gastric pouch, measuring and connecting intestinal limbs, and closing defects. A methylene blue leak test is done to check for leaks, and the entire Roux-en-Y gastric bypass is completed with magnet-assisted maneuvers. Participants undergo this bariatric procedure with magnetic assistance and are monitored for complications within 30 days, device malfunction within 1-2 hours post-procedure, and surgical time within 30 days. The study includes evaluations of surgical field exposure, anastomosis construction, and hernia repair. The total participation timeline includes the surgical procedure and follow-up assessments up to 30 days after surgery.

Researchers are developing and validating a wearable sensor designed to help patients with Parkinson's Disease (PD) who have swallowing difficulties and drooling problems. This study focuses on improving the device's battery life and size, assessing usability with patient feedback, and testing its ability to detect and encourage swallowing in PD patients. The aim is to provide a digital therapeutic platform that can support swallowing function in this population. The wearable device, called the Aria sensor, is a patch that monitors physiological signals continuously and provides vibratory haptic cues to increase how often participants swallow. Participants will use the sensor for three weeks, with the device actively providing haptic cues only during the second week. This single-arm study tracks how the sensor performs in real-life conditions without randomization or blinding. Participants will be involved for three weeks, during which researchers will measure swallow frequency changes, participant adherence to using the haptic cues, and changes in clinical scales related to drooling and swallowing. Assessments include comparing sensor data to a gold standard and evaluating symptom severity before and after the intervention. The study also includes focus groups to gather patient feedback on usability, and safety monitoring is conducted throughout the study period.

Researchers are conducting a non-interventional, observational study to understand patients in Germany receiving dupilumab for eosinophilic esophagitis (EoE). The study focuses on patients' medical history, socio-demographic and disease characteristics, other related conditions, concurrent therapies, and prior EoE treatments. It also aims to evaluate the long-term effects of dupilumab on disease symptoms and patients' quality of life over a two-year period. Participants in this study are those already prescribed dupilumab by their treating physicians in routine clinical practice; no treatments are administered by the study itself. The study observes dupilumab use patterns, safety, and effectiveness during the two years of follow-up. Patients will be followed for approximately 24 months after starting dupilumab treatment with assessments at multiple timepoints to track changes in symptoms, biopsy results, and quality of life measures. During the study, participants will undergo evaluations including medical history review, clinical symptom assessment, endoscopic scoring, esophageal biopsies, and questionnaires on anxiety, depression, and quality of life. Researchers will also collect data on hospitalizations and sick leave related to EoE. Safety will be monitored throughout, and the total participation time for each person is about two years, within a four-year overall study timeline.

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.

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 healing rates of reflux esophagitis classified as LA grade B or higher. This study compares three treatments: Vonaprazan 10 mg, Vonaprazan 20 mg, and Esomeprazole 40 mg, taken once daily for 8 weeks. The purpose is to assess which treatment helps heal the esophagus and improves reflux symptoms, as measured by the GERD-Q score, while also monitoring for side effects. Participants will be randomly assigned to one of three groups to receive either Vonaprazan 10 mg, Vonaprazan 20 mg, or Esomeprazole 40 mg once daily for 8 weeks. The study is open-label, meaning participants and doctors know the treatment given, but those assessing the healing results are blinded to reduce bias. Treatments focus on acid reduction to promote healing. During the study, participants undergo an upper gastrointestinal endoscopy at the start to confirm esophagitis severity and again after 8 weeks to check healing progress. GERD symptoms are recorded at the beginning, at 4 weeks, and at 8 weeks. Researchers also track medication adherence and any adverse events. The main outcome is the healing of esophagitis at 8 weeks, alongside symptom improvement and safety monitoring throughout the treatment period.

The FARE Patient Registry is a prospective observational study focused on collecting detailed health and basic information about individuals living with food allergies. Its purpose is to encourage open sharing of de-identified data and to support participation in clinical trials, ultimately aiming to advance scientific discoveries related to food allergy causes and contributing factors. This registry does not involve any treatment or interventions but gathers real-world experiences from participants with food allergies. It serves as a platform for the food allergy community to contribute data that can help researchers understand the extent and etiology of food allergies. Participants provide their health information and experiences, which are stored in the registry for ongoing research use. The main outcome measured is the creation of a registry that characterizes food allergies and factors influencing their development. The study is observational, with no interventions, and participation can continue until the study end date in August 2027.

Researchers are evaluating vonoprazan, a drug taken once daily at 20 mg, in adults with eosinophilic esophagitis (EoE), a condition characterized by a high number of eosinophils in the esophagus. The study aims to compare vonoprazan to a placebo to see how many participants achieve a peak eosinophil count below 15 eosinophils per high-power field after 12 weeks of treatment. This phase 2, randomized, double-blind study is sponsored by Phathom Pharmaceuticals, Inc. and involves adult participants who meet specific clinical and diagnostic criteria for EoE. Participants are randomly assigned to receive either vonoprazan 20 mg daily for 12 weeks followed by an additional 12 weeks at the same dose, or placebo for 12 weeks followed by 12 weeks of vonoprazan 20 mg daily. The study is conducted across multiple centers and includes a double-blind design to compare the safety and efficacy of vonoprazan against placebo initially and then evaluate continued treatment effects up to 24 weeks. During the trial, participants will be monitored through various assessments including esophageal biopsies to measure eosinophil counts, electronic diaries documenting dysphagia episodes, and endoscopic scoring for EoE severity. The main outcome is the number of participants achieving reduced eosinophil levels at week 12. Secondary assessments include changes in dysphagia days, endoscopic reference scores, and eosinophil counts from baseline to week 12. Safety and adherence will be tracked throughout the study period, with participant involvement expected for up to 24 weeks.

Researchers are evaluating the safety of vonoprazan exposure during pregnancy by comparing outcomes for pregnant women who take vonoprazan with those who do not but may use other treatments for similar conditions. The study focuses on maternal, fetal, and infant health, particularly monitoring for congenital malformations and various pregnancy outcomes related to erosive esophagitis, heartburn, symptomatic non-erosive gastroesophageal reflux disease, and Helicobacter pylori infection. The study includes two groups: pregnant women exposed to vonoprazan and those not exposed but possibly treated with other medications for related conditions. Vonoprazan is given as an oral tablet. Participants are observed from conception through pregnancy outcome, and infants are followed for up to 12 months after birth to assess health and development. Participants will provide consent and authorize their healthcare providers to share relevant data. Researchers will track major and minor congenital malformations, spontaneous abortion, stillbirth, elective termination, preterm birth, small gestational age at delivery, postnatal growth deficiencies, and developmental delays. Follow-up includes monitoring pregnancy outcomes and infant development for up to one year after birth, ensuring comprehensive safety evaluation over time.

Researchers are evaluating the safety, effectiveness, and how the body processes EP-104GI, an extended-release fluticasone propionate injectable suspension, in adults with eosinophilic esophagitis (EoE). This Phase 1b/2 study aims to understand the local effects of EP-104GI on disease activity using endoscopic and tissue assessments. About 160 participants will be enrolled across dose escalation and randomized dose optimization phases to identify recommended doses and assess outcomes. Participants will receive EP-104GI or a matching vehicle control through submucosal injections during an esophagogastroduodenoscopy (EGD) procedure at the baseline dosing visit. The dose escalation phase will enroll 27 to 33 participants in different dose cohorts, while the randomized phase will assign about 120 participants to one of two dose levels or vehicle control. Those on vehicle control may switch to EP-104GI after 24 weeks if eligible. Additional substudies may include extended pharmacokinetic follow-up. During the study, participants will attend 8 to 10 visits over approximately 52 weeks, with some having up to 4 extra visits extending to 108 weeks. They will undergo 3 to 5 EGD procedures with biopsies to monitor disease changes and safety. Blood and urine samples will be collected for laboratory tests and drug level measurement. Questionnaires will track symptoms like difficulty swallowing and pain when swallowing. Safety and physical health will be regularly assessed throughout the trial.