Functional Dyspepsia

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.

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.

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 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 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.

Dyspepsia includes a variety of upper digestive symptoms such as abdominal pain, bloating, nausea, and heartburn, affecting up to 40% of people worldwide and lowering quality of life. This study evaluates a natural product called Chios mastic water, which has antimicrobial, anti-inflammatory, and antioxidant properties. Researchers aim to see if a beverage enriched with this extract can improve dyspepsia symptoms and quality of life in adults. This is a 3-month randomized, double-blind controlled clinical trial involving adults aged 30 to 60 years with dyspepsia. Participants are randomly assigned to one of two groups: the intervention group receives 600 mL daily of a sparkling beverage enriched with 0.2% natural mastic aqueous extract, while the control group receives an identical placebo beverage without active ingredients. Both groups consume three 200 mL bottles daily for three months. Participants are asked to maintain their usual diet, physical activity, and medical treatments during the trial. The study team and participants are blinded to group assignments. At the start and end of the study, researchers assess body measurements, lifestyle habits, dyspepsia symptom severity, and quality of life. Blood samples are collected to measure biochemical markers like glucose metabolism, liver enzymes, and inflammatory markers. Researchers monitor side effects and may stop the intervention if needed. The primary outcome is the change in dyspepsia symptom severity after 12 weeks, along with changes in quality of life and inflammatory markers.

Researchers are studying how the intestinal bacteria in people with systemic sclerosis-related constipation and/or significant bloating may change after receiving microbiome transplantation. This Phase 2 study aims to understand the safety and tolerability of two types of microbiome transplant products (frozen and lyophilized PRIM-DJ2727) and how these treatments affect gut bacteria diversity and patient symptoms. Participants will be randomly assigned to receive either the microbiome transplant or a placebo. The transplant is given both as capsules taken twice weekly from week 2 through week 10, and as a retention enema at the start and during week 11. The placebo group receives matching capsules and enemas on the same schedule. This design helps compare effects between the active treatment and placebo. During the study, participants will have their symptoms assessed using several questionnaires and stool diaries before treatment and at week 12. Researchers will also monitor gut transit times, inflammatory markers, and changes in gut bacteria. The study includes follow-up visits to evaluate safety and outcomes over 12 weeks. The goal is to track improvements in constipation and bloating and understand changes in gut microbiome composition.

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.