Irritable Bowel Syndrome (IBS)

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 conducting the GENESIS clinical study to map the HLA genomic region in the Greek population and explore its possible links with various underlying diseases. This non-interventional, multicenter study aims to provide a pilot map of genetic variation in HLA that may be useful in medical research and clinical applications related to selected diseases. The study plans to include 12,000 participants over a total duration of 36 months. Each participant will attend one visit at a participating site during which they will provide demographic data, lifestyle information such as smoking and alcohol use, blood pressure measurements, details on diagnosed diseases and treatments, and recent laboratory test results if available. Buccal swab samples will be collected from each participant to extract DNA for HLA genotyping analysis. Selected samples will undergo further whole genome sequencing to investigate associations with autoimmune diseases. Participants will receive a personalized ancestry report after analysis completion. During the study visit, data collection includes demographic and health information, as well as laboratory and clinical test results from the past year. The genetic material from buccal swabs will be stored and processed for genetic analysis. Researchers will measure allele frequency of HLA alleles in the Greek population and assess the prevalence and risk associations of selected HLA-related diseases. The study's total duration is 36 months with results available at the end of this 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.

Researchers are investigating the relationship between gut microbiota dysfunction and Alzheimer's disease (AD), focusing on how gut-derived short-chain fatty acids (SCFAs) may influence brain function through the "gut microbiota-SCFAs-brain networks" pathway. This observational study will explore differences in SCFAs among people across the AD spectrum, including cognitively normal individuals, those with subjective cognitive decline (SCD), mild cognitive impairment (MCI), and AD dementia. The project aims to clarify the interactions between gut microbiome, metabolites, and brain changes using high-throughput metabolomics and multi-modal MRI techniques. Participants will be grouped into four categories: cognitively normal, SCD, MCI, and AD dementia. The study involves collecting multi-omics data, including gut microbiome analysis, metabolomics, and neuroimaging, to establish a diagnostic model for SCD due to preclinical AD using machine learning methods. The study spans five years, during which gut microbiome changes, SCFAs levels, and multi-omics biomarkers related to cognitive impairment conversion will be monitored. Participants will undergo cognitive tests and brain imaging scans, along with gut microbiome and metabolite sample collection. Researchers will assess the interaction mechanisms of the gut microbiota-SCFAs-brain networks over five years. The study includes both healthy volunteers and patients aged 60 to 80. Outcome measures focus on changes in gut microbiome, SCFAs, and biomarkers linked to cognitive decline, with long-term follow-up to better understand the disease progression and its early detection.

Researchers are studying pregnant women to understand how microbiome, proteomics, and serum markers might help predict preeclampsia, a condition that can affect pregnancy. This multicenter, prospective cohort study also aims to explore how these biological markers relate to pregnancy outcomes such as complications during pregnancy, delivery, and the newborn's health. The study is conducted by Zhujiang Hospital and focuses on maternal and infant microecology in China. Pregnant women who come to the hospital before 14 weeks of gestation are invited to participate. After consenting, they will complete a questionnaire and provide samples including urine, serum, saliva, vaginal swabs, and feces at several points during pregnancy: 11-14 weeks, 22-28 weeks, 32-34 weeks, and at delivery. If possible, placenta, cord blood, and amniotic fluid will also be collected at delivery. Women with preeclampsia during pregnancy will be followed up with similar sampling up to two years after their child is born. Participants will be monitored through various laboratory assessments including 16S rRNA gene sequencing for microbiome analysis and advanced techniques like MALDI-TOF peptidomics and mass spectrometry metabonomics. The study will also evaluate patient-specific risk of preeclampsia using clinical measurements such as mean arterial pressure and serum placental growth factor. Follow-up visits after delivery will occur at 6 weeks, 6 months, 1 year, and 2 years to continue monitoring maternal and infant health. The primary outcomes include microbiome, proteomics, and metabonomics data collected over 34 months, with secondary outcomes assessed over 10 months.

Frailty is a common condition in older adults that can increase the risk of poor health outcomes such as falls, hospital stays, and death. This research aims to study how assessing frailty before a colonoscopy might affect patient satisfaction and the number of colonoscopies avoided. The study is a prospective randomized controlled trial involving patients over 65 years old at Princess Alexandra Hospital, comparing a personalized approach using a frailty assessment to standard care. Participants will be randomly assigned to one of two groups. One group will receive a personalized approach that includes a frailty assessment using tests like grip strength, sit-to-stand timing, balance, and gait speed, along with questionnaires about medical conditions. The gastroenterologist will discuss the results and risks with the patient to help decide about having a surveillance colonoscopy. The other group will receive standard care, which involves discussing the benefits and risks of colonoscopy without the frailty assessment. During the study, participants will complete satisfaction questionnaires at the time of consultation and within weeks after any colonoscopy procedure. Researchers will track how many patients choose to avoid colonoscopy after receiving information and will monitor colorectal cancer-related complications and other causes of death within five years. The study will assess how the personalized approach may impact decision-making and patient satisfaction with outpatient services related to colonoscopy care.

Researchers are evaluating a combined screening and follow-up management approach for gastrointestinal tumors. This study aims to explore and assess the feasibility and cost-effectiveness of screening for esophagus, stomach, and colorectal cancers in a population-based, multicenter setting. The trial includes participants aged 45 to 70 years and will observe outcomes over a 10-year follow-up period. Participants are divided into groups undergoing different screening methods. Group one receives gastroscopy, colonoscopy, fecal occult blood test (FIT), Helicobacter pylori antigen test, RNF180 and SEPTIN9 gene methylation tests, along with an investigation of various risk factors such as past diseases, lifestyle habits, family cancer history, and reproductive status. Group two undergoes risk factor investigation, FIT, and Helicobacter pylori antigen stool test; if positive, further gene methylation tests and possibly colonoscopy are conducted. Control groups matched by spouse or sibling undergo only risk factor investigations. During the study, participants provide information on medical history, lifestyle habits, and family cancer history. Screening tests including endoscopies, stool tests, and gene methylation analyses are performed as specified. Researchers will monitor the detection of cancer or precancerous lesions over 10 years, tracking health outcomes and the effectiveness of combined screening. Safety and adherence are observed throughout the follow-up.

Researchers are evaluating the effectiveness and cost-efficiency of early remote interventions for patients with severe, chronic, or relapsing gastrointestinal symptoms that lack clear explanation and who are waiting for care in an integrated clinic. The study uses a two-stage randomization to compare different approaches, aiming to improve symptom management, identify which patients respond best to certain treatments, and assess acceptance of new care models. About 200 patients will initially have their symptoms and wheat intolerance assessed remotely. Participants who continue to experience symptoms after initial assessment will be randomly assigned to one of four pre-consultation interventions: a standardized dietician-supervised program, an exercise program, internet-delivered cognitive behavior therapy, or no intervention. Following this, they will be randomized again to receive either a consultant-led outpatient clinic consultation or care in an integrated clinic, depending on their response to the pre-consultation intervention. Throughout the study, participants will be regularly assessed using a structured gastrointestinal symptoms score and quality of life measures, collected at multiple time points up to 44 weeks. Additional evaluations include anxiety and depression scales, microbiome analysis, and acceptance of care models by patients and staff. Cost-effectiveness will also be tracked. The total participation involves remote interventions, clinical consultations, and multiple assessments over time to monitor symptoms, quality of life, and treatment impact.

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.