Clinical Research Directory

Health Outcomes in C-Section Infants With Fecal Microbiota Transplantation

The goal of this clinical trial is to investigate the differences in microbiota, height and weight between infants born by cesarean section and randomized to receive fecal microbiota transplant after birth. The main questions it aims to answer are: * Could micobiota transplant be used improve gut microbiota and prevent overweight or obesity. * Is the source of colonization a modifiable factor and can it be changed by using an early fecal microbiota transplant.

Using Healthy Gut Bacteria to Boost Immune Treatment for Advanced Bowel Cancer

This research protocol outlines an exploratory study on the combination of early-life fecal microbiota transplantation (yFMT) with immunotherapy and chemotherapy in patients with microsatellite stable metastatic colorectal cancer (MSS mCRC). The single-center, single-arm study aims to assess the safety of yFMT in conjunction with immunotherapy and chemotherapy, with a secondary focus on exploring its efficacy and impact on the patients' immune microenvironment. The study will enroll 10 patients aged 18-75 who have progressed after first-line chemotherapy and targeted therapy. The intervention involves six sessions of yFMT every two weeks, alongside PD-1 inhibitor immunotherapy and FOLFIRI chemotherapy. The primary endpoints are the incidence of serious adverse events (SAEs), treatment-related adverse events (TRAEs), and intervention adjustments due to adverse events, while secondary endpoints include progression-free survival (PFS), objective response rate (ORR), and overall survival (OS). The study is expected to last two years from initiation to data analysis completion, and it will be conducted at the Gastrointestinal Tumor Surgery Department of the First Affiliated Hospital of Xiamen University.

Evaluation of the Outcome of Fecal Microbiota Transplantation

This study is a randomized, placebo-controlled, exploratory phase II clinical trial led by Professor Han Gyeong-ho from the Digestive Disease Hospital of Xi'an International Medical Center. The study enrolled 40 patients who had experienced recurrence of hepatic encephalopathy despite treatment with rifaximin and lactulose. These patients were randomly divided 1:1 into the experimental group and the control group. After obtaining informed consent from the patients, fecal microbiota transplantation or placebo control was performed. The fecal microbiota was sourced from the feces of healthy individuals who had a rich composition of the Muribaculaceae, Ruminococcaceae, and Bifidobacteriaceae families and did not contain pathogenic bacteria. The safety and efficacy of the treatment were followed up, and blood and fecal samples were collected for sequencing analysis. The aim was to provide new solutions for patients with hepatic encephalopathy who did not respond to the treatment with rifaximin and lactulose after TIPS surgery; and to explore the impact of microbiota changes and translocation on the recurrence of hepatic encephalopathy after TIPS surgery.

The Efficacy and Safety of Microbiota Transplantation Combined With Prebiotics for Treatment of Functional Constipation

Chronic constipation is a common gastrointestinal disorder with a global prevalence of approximately 15%, severely impacting daily life and quality of life. It also increases the mortality rate from hypertension, cardiovascular diseases, and ischemic stroke, and is closely related to the incidence of colorectal cancer, making it a major chronic disease that seriously threatens people's health and quality of life. With the increasing aging population and lifestyle factors such as sedentary behavior and low-fiber diets, the incidence of functional constipation is gradually rising. Traditional treatment of chronic constipation mainly relies on various types of laxatives, which have significant side effects with long-term use and relatively high treatment costs, while surgical treatment has limited patient acceptance. Gut microbiota is closely related to intestinal motility, and patients with chronic constipation often have gut microbiota dysbiosis, with significant differences in gut microbiota diversity and colonic mucosal microbiota structure compared to healthy individuals. In recent years, more and more studies have found that intestinal microbiota-based therapies such as probiotics, prebiotics, synbiotics, postbiotics, and fecal microbiota transplantation (FMT) can effectively prevent and treat chronic constipation. FMT, as a method to reshape the gut microbiota, has been widely used in many centers at home and abroad, for diseases including inflammatory bowel disease, irritable bowel syndrome, autism, and obesity. The overall adverse reaction rate in clinical applications is approximately 3%, mainly consisting of abdominal discomfort (bloating, abdominal pain), diarrhea, and secondary intestinal infections or even bacteremia (rare). Our center has established a fecal microbiota transplantation center at Beijing Sixth Hospital within our medical alliance. We have currently performed nearly 100 cases of FMT for the treatment of IBD, autism, functional bowel diseases, and other metabolic diseases, with a clinical efficacy rate of 64-85% for functional constipation and constipation-predominant irritable bowel syndrome. This project aims to validate an intervention strategy combining fecal microbiota transplantation (FMT) with prebiotics primarily composed of high dietary fiber, based on the theoretical framework developed by the team led by Diwei Zheng at the Institute of Process Engineering, Chinese Academy of Sciences.The team found that the core microbiota playing a major role in the FMT process determines the therapeutic efficacy of FMT on diseases.These core microbial communities can produce acetic acid and butyric acid, which are important metabolites that not only reduce inflammatory levels and improve intestinal barrier function, but also provide energy for intestinal epithelial cells. Additionally, they effectively limit the growth of opportunistic pathogens by acidifying the intestinal environment, exerting antibacterial effects, and utilizing niche effects.Therefore, when the core microbiota occupies a dominant ecological niche in the gut, the gut microbiota can support health from multiple aspects including nutrition, immunity, metabolism, and psychology. Prebiotics designed based on the characteristics of the core microbiota can significantly enhance the activity and colonization of the core microbiota.This study aims to reconstruct a healthy intestinal ecosystem through FMT and prebiotics. Simultaneously, it proposes a "co-localization" strategy, which involves physically mixing prebiotics with core microbiota during transplantation to coexist synergistically. This approach enhances the metabolic function of core microbiota more efficiently locally, promotes the production of key metabolites such as acetic acid and butyric acid, and improves the intestinal microenvironment.Compared with the traditional stepwise model of 'microbiota transplantation + prebiotic intervention', this approach can significantly reduce the dosage of prebiotics, thereby further enhancing the safety and tolerability of the intervention.This clinical study is designed as an open-label, single-arm trial, aiming to enroll 19 patients with refractory functional constipation to receive "core microbiota transplantation based on co-localization".The study will focus on evaluating the therapeutic efficacy of the treatment in improving constipation symptoms, systematically assessing its safety, and comprehensively evaluating the level of gut microbiota remodeling through microbiome and metabolome approaches.The implementation of this project will provide clinical evidence for exploring the application of core microbiota therapy in functional bowel disorders such as constipation, and lay the foundation for optimizing and promoting microecological intervention strategies.

Fecal Microbiota Transplant National Registry

A national data registry of patients receiving fecal microbiota transplantation (FMT) or other gut-related-microbiota products designed to prospectively assess short and long-term safety and effectiveness

Long-term Efficacy and Safety of Fecal Microbiota Transplantation in Patients With Ulcerative Colitis

This study aims to perform fecal microbiota transplantation (FMT) and analyze its effects in selected patients aged between 10 and 80 years who have been diagnosed with ulcerative colitis and have been receiving treatment for more than three months at Seoul National University Hospital, Seoul National University Boramae Medical Center, and Seoul National University Bundang Hospital. Through this analysis, the study seeks to identify the long-term efficacy of FMT as a treatment for ulcerative colitis, evaluate the safety of the procedure, and establish a foundation for personalized FMT based on gut microbiota analysis.

Efficacy and Mechanism of FMT in the Treatment of Inflammatory Bowel Disease: an Open-label Randomized Controlled Study

This study enrolled 94 patients with UC or CD. Two groups received either 8-week intestinal bacterial transplant capsule therapy or biological therapy, respectively. The control group received biological therapy alone, while the experimental group received biological therapy combined with FMT. Both groups were followed up for 52 weeks after discharge. The efficacy of FMT capsule therapy on the subjects' UC or CD symptom-related scores and its effect on remodeling the intestinal flora were observed, and its safety was verified.

Fecal Transplantation to Eradicate Colonizing Emergent Superbugs

Carriage of multi-drug and extensive-drug resistant Gram negative bacteria (MDR-GNB) is associated with an increased risk of infections by these bacteria for the carriers and a high risk of dissemination both in the healthcare setting and the community; the main MDR-GNB reservoir is the fecal microbiota. To prevent both infections and dissemination, effective measures to decolonize subjects carrying MDR-GNB are urgently needed. Animal models, case reports and cohort studies suggest fecal microbiota transplantation (FMT) may be efficient for MDR-GNB decolonization.

Clinical Safety and Efficacy of Fecal Microbiota Transplantation (FMT) in the Treatment of Alzheimer's Disease

To investigate the clinical safety and efficacy of FMT in AD patients, as well as the changes in the gut microbiota of AD patients before and after FMT.

Microbial Restoration in Inflammatory Bowel Diseases

This is a prospective, two-centre, double-blind, parallel-arm, randomised, placebo-controlled trial evaluating the impact of FMT on patients with active Crohn's disease.

Fecal Microbiota Transplantation for the Prevention of Infectious Complications After Liver Transplantation

The increasing emergence and spread of MDRB represents a major public health problem, with higher mortality in patients experiencing infections. Cirrhotic patients listed for OLT and after OLT are at high risk of MDRB colonization or infection due to the large use of broad-spectrum antibiotics in the post-transplant setting. Therefore, effective decolonization strategies in this particular setting are urgently needed. The investigators hypothesize that heterologous FMT can reduce infections rates in the pre-and post- OLT setting by MDRB decolonization and restoration of a more physiological microbiome.

Synbiotics and Fecal Microbiota Transplantation to Treat Non-Alcoholic Steatohepatitis

The goal of this clinical trial is to investigate the therapeutic potential of A. soehngenii and pasteurized A. muciniphila combined with B. animalis subsp. lactis and fructo-oligosaccharides with and without conditioned vegan lyophilized fecal microbiota transplantation capsules to reduce NASH in patients with fibrotic NASH. The main questions to answer are: 1. Can NASH be treated by altering the gut microbiota using LFMT capsules? 2. Can NASH be treated using a syntrophic cocktail of synbiotics and will these strains strengthen the effect of FMT? 3. What are the underlying mechanism by which the aforementioned treatments attenuate NASH? Participants will be treated with FMT-capsules or placebo, and all participants will receive a cocktail of 3 strains of probiotics and one type of prebiotic.

Fecal Microbial Transplantation for Rheumatoid Arthritis Trial

This clinical trial will investigate the effects of capsules containing stool from healthy donors, called fecal microbial transplant (FMT), in rheumatoid arthritis patients.

Efficacy and Safety of FMT for the Treatment of IBS-D and Mental Health Comorbidity in Young Adults

The purpose of this study is to evaluate the efficacy and safety of Fecal Microbiota Transplantation compared with placebo in the treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D) and Mental Health Comorbidity in Young Adults.

Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in Reducing Recurrence of Colorectal Adenoma (CRA)

The goal of this clinical trial is to learn about the efficacy and safety of fecal microbiota transplantation in reducing recurrence of colorectal adenomas after endoscopic resection. The main questions it aims to answer are: * the efficacy and safety of fecal microbiota transplantation in reducing the recurrence rate of colorectal adenomas after endoscopic resection. * changes in the intestinal and mucosal microbiota of patients before and after endoscopic treatment. * changes in the intestinal and mucosal microbiota of patients before and after fecal microbiota transplantation. Participants are required to complete one colonoscopy and infuse 150ml of fecal suspension into the terminal ileum under endoscopy, performing the first fecal microbiota transplantation (FMT) on day 0. Subsequently, for 2 days continuously (day 1-2), the participants will undergo microbiota transplantation in the form of oral capsules, taking 40 FMT capsules within one day (20 capsules bid). Subsequently, participants will receive a maintenance treatment with oral FMT capsules (20 capsules bid) at 3, 6, and 9 months (approximately every 75 to 90 days). Participants will undergo their first follow-up colonoscopy between 6 to 12 months(the high-risk adenoma group will receive colonoscopy at 6 months, and the low-risk adenoma group will receive colonoscopy at 12 months).

Fecal Microbiota Transplantation in the Treatment of Major LARS

Randomized trial to assess FMT efficacy in improving bowel function for major LARS patients. 40 subjects, blinded, randomized to FMT or probiotics. Pre-post 16S sequencing, 4-week follow-up for bowel symptoms, 8-week microbiota analysis.

Standardized Fecal Microbiota Transplantation for Ulcerative Colitis

The gut microbiota is considered to constitute a "microbial organ" which has pivotal roles in the intestinal diseases and body's metabolism. Evidence from animal and human studies strongly supports the link between intestinal bacteria and inflammatory bowel diseases (IBD). Dozens of studies reported its efficacy in treatment of severe Clostridium difficile colitis. Preliminary studies using FMT for Ulcerative Colitis (UC), Crohn's diseases, irritable bowel syndrome (IBS) and constipation have also met with some success. This is an initial step into investigating the potential efficacy of standardized fecal bacteriotherapy through mid-gut (at least below duodenal papilla) for UC, the investigators propose to determine the efficiency and safety of FMT in a series of 500 patients with moderate to severe UC (Montreal classification).

Dietary Counseling Coupled With FMT in the Treatment of Obesity and NAFLD - the DIFTOB Study

There are several studies performed to reveal the linkage between diet, fecal microbiota, and obesity. Human fecal microbiota transplantations in this asset are still scarce. Therefore, this pilot study of FMT from lean to obese people with dietary counseling will increase the knowledge, whether FMT could play a role in the treatment of obesity and NAFLD. Our primary outcome is the changes in glucose metabolism by HOMA-IR.

Fecal Microbiota Transplantation for Irritable Bowel Syndrome Associated Food Intolerance

Previous studies have shown that stool transplantation (FMT) have positive effect in symptoms for some patients with irritable bowel syndrome (IBS). Studies have shown that it is possible by FMT to reverse the microbiome of the recipient's intestine in the direction of the microbiome of the donor. The effect on eating habits for engraftment of microbiome by FMT is unknown. The purpose of this study is to investigate whether FMT relieves FODMAP diet extension without worsening intestinal symptoms in IBS patients.

Fecal Microbiota Transplantation for Irritable Bowel Syndrome

Fecal microbiota transplantation (FMT) is a strategy that infuses a fecal suspension containing a healthy donor's microbiota into a patient's gut to restore his/her intestinal microbiome. FMT has a higher cure rate than standard antibiotic treatment for recurrent Clostridium difficile infections,and shows promising results in Inflammatory bowel disease（IBD）.However, few studies have evaluated whether FMT is effective to treat Irritable bowel syndrome(IBS).The investigators propose to determine the efficiency and safety of FMT in patients with Irritable bowel syndrome.

Efficacy and Safety of Fecal Microbiota Transplantation

In recent years, researches illustrate that multifactorial diseases such as functional gastrointestinal disorders, autoimmune diseases, metabolic, behavioral and neurological diseases are associated with an abnormal microbiome structure-dysbiosis, which means the imbalance of the microbiome community. Fecal microbiota transplantation (FMT), the infusion of faeces from a healthy donor to the gastrointestinal tract of a recipient patient aiming to alter the intestine microbiota, is recommended to be performed in Clostridium difficile infection(CDI) as the most effective therapy. It also being used experimentally in the treatment of the disease states linked to dysbiosis of the intestinal microbiota. However, the efficacy and safety of FMT to treat the dysbiosis-associated diseases is still in its infancy. To further verify the indications above, more data is required to be collected through studies.

Fecal Microbiota Transplantation for Ulcerative Colitis

Fecal microbiota transplantation (FMT) is a strategy that infuses a fecal suspension containing a healthy donor's microbiota into a patient's gut to restore his/her intestinal microbiome. Fecal microbiota transplantation has been used for several disease，but the efficacy of ulcerative colitis(UC) by fecal microbiota transplantation needs to be further explored.The investigators propose to determine the efficiency and safety of FMT in patients with ulcerative colitis(UC).