Gut Microbiome Dysbiosis

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.

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 a new nutritional supplement's effects on nutrient gaps, nutrient status, and gut microbiome health in adults using glucagon-like peptide-1 receptor agonists (GLP-1 RAs). This triple-blind, placebo-controlled, randomized trial involves 120 participants aged 18 to 59 years. The study aims to better understand how this supplement might influence nutrition and gut health among GLP-1 RA users. Participants are randomly assigned to receive either the AG1 nutritional supplement or a placebo made of maltodextrin. The study maintains triple blinding to ensure unbiased results. The treatment period lasts 90 days, during which participants follow their usual GLP-1 RA maintenance dose without changes. The trial monitors nutrient gaps, nutrient status markers, and gut microbiome changes at the end of this period. Throughout the study, participants must adhere to specific protocols including maintaining current diet, sleep, and activity levels, avoiding new supplements or medications, and following pre-test restrictions such as fasting and avoiding caffeine and exercise before blood tests. Researchers collect data on nutrient and microbiome outcomes and monitor adherence through reported behaviors and weighing scale access. The total participation duration is 90 days, with detailed assessments to evaluate the supplement's impact safely and accurately.

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 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 exploring whether the virus that causes COVID-19, called SARS-CoV-2, is present in the stool of infected patients. The study aims to understand the role of gut flora during and after COVID-19 infection by examining stool samples for viral shedding. This non-interventional pilot study is led by ProgenaBiome and focuses on the gastrointestinal microbiome in people diagnosed with COVID-19. Participants will provide stool samples that will be analyzed to sequence the microbiome. Samples will be collected during treatment for COVID-19 and again after treatment to determine if and when the virus is shed in the stool. The study involves observing the general population's microbiome through these samples without any intervention or treatment imposed. During the study, participants will have their stool microbiome sequenced to analyze the relative abundance of microbes and correlate it with the disease over the course of one year. Researchers will validate sequencing methods and monitor the gut microbiome changes. The study includes follow-up assessments and does not involve any active treatment, focusing instead on data collection and analysis over the study period.

This research aims to evaluate how a nasal microbiota transplant (NMT) from parents affects the diversity of the nasal microbiome in infants after they have been treated with intranasal mupirocin to clear Staphylococcus aureus colonization. The study focuses on infants in a neonatal intensive care unit who have undergone nasal decolonization and seeks to understand the impact of this transplant on the infant's nasal bacterial community. Participants will be randomly assigned to one of three groups: a single NMT where a swab from the parent's nose is inserted once into the child's nose, a repeat NMT with multiple swab insertions, or a placebo group where a sterile swab is inserted without microbiota transfer. The interventions take place after baseline screening, and the study is designed as a phase 1, randomized trial without masking. During the study, researchers will monitor pediatric nasal microbiome diversity at several time points after the intervention—specifically on days 2, 4, 7, 10, and 14. Assessments include nasal swabs and microbiome analyses to evaluate how well the transplant affects bacterial diversity. Infant participants are expected to remain hospitalized for at least three days post-treatment to allow monitoring. The study duration extends to 2028 and involves healthy volunteers aged from birth up to 5 years old.

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 studying how changes in the gut microbiome relate to hormonal changes during women's ageing, especially throughout menopause. This observational study focuses on healthy women aged 40 to 64 living in Portugal. It aims to understand how menopause affects long-term health by examining gut microbiome, hormone levels, and markers of chronic low-grade inflammation, to help develop better prevention strategies for women's health. Participants are grouped by menopausal stage: premenopausal with regular periods, perimenopausal with irregular periods and some menopausal symptoms, and menopausal/postmenopausal with no menstruation for 12 months. Women will provide stool and blood samples and complete questionnaires about their health, lifestyle, diet, and menopausal symptoms. The study collects data over 10 years, with baseline and follow-up assessments every two years. During the study, participants will be assessed for gut microbiome composition and function, hormone levels, inflammation markers, menopause-related symptoms, nutrition, physical activity, sleep habits, and stress levels. These evaluations help researchers identify microbiome and blood biomarkers linked to menopause and ageing. Participation involves regular sample collection and questionnaires, with ongoing monitoring to support personalized risk assessment and prevention in women's health.