Fecal microbiota transplantation (FMT) has gradually shown application prospects in the treatment of intestinal and extraintestinal diseases. In order to standardized FMT operation, based on the clinical experience of the Tenth People's Hospital Affiliated to Tongji University, combined with domestic and foreign literature, Parenteral and Enteral Nutrition Branch of Chinese Medical Association, Enhanced Recovery after Surgery Branch of China International Health Care Promotion Exchange Association, China Microecological Treatment Innovation Alliance, and Microecology Committee of Shanghai Preventive Medicine Association to formulated the" Chinese experts consensus on clinical practice of the selection and establishment of fecal microbiota transplantation delivery routes". It includes four parts: the selection of delivery route, the methodology of transplantation path establishment, the clinical application, and the monitoring of adverse events.
China ; Consensus ; Fecal Microbiota Transplantation ; adverse effects ; methods ; standards ; Humans

Fecal microbiota transplantation (FMT) has been used as a core therapy for treating dysbiosis-related diseases by remodeling gut microbiota. The methodology and technology for improving FMT are stepping forward, mainly including washed microbiota transplantation (WMT), colonic transendoscopic enteral tubing (TET) for microbiota delivery, and purified Firmicutes spores from fecal matter. To improve the understanding of the clinical applications of FMT, we performed a systematic literature review on FMT published from 2011 to 2021. Here, we provided an overview of the reported clinical benefits of FMT, the methodology of processing FMT, the strategy of using FMT, and the regulations on FMT from a global perspective. A total of 782 studies were included for the final analysis. The present review profiled the effectiveness from all clinical FMT uses in 85 specific diseases as eight categories, including infections, gut diseases, microbiota-gut-liver axis, microbiota-gut-brain axis, metabolic diseases, oncology, hematological diseases, and other diseases. Although many further controlled trials will be needed, the dramatic increasing reports have shown the promising future of FMT for dysbiosis-related diseases in the gut or beyond the gut.
Humans ; Fecal Microbiota Transplantation/methods* ; Dysbiosis/therapy* ; Gastrointestinal Microbiome ; Feces ; Microbiota

Objective: To explore and establish the preparation system of human intestinal fluid transplantation (HIFT) and HIFT capsule, and to preliminarily apply it to clinic. Methods: Strict standards for donor screening and management were established. The nasojejunal tube was catheterized into the distal jejunum, and then it was connected with an improved disposable sterile negative pressure collection device for the collection of human intestinal fluid. After that, it was prepared into capsules by filtering, adding 10% glycerin protectant and freeze-drying method. The amount of living bacteria was used as the standard of therapeutic dose. The living bacteria amount in fluid is ≥ 5.0×10⁸ /mL and the living bacteria proportion is ≥ 83%; the living bacteria amount in powder is ≥ 2.0×10⁶ /g and the living bacteria proportion is ≥ 81%; The observational indicators included: (1) the basic information of the donor, the amount of living bacteria in the HIF and powder. (2) Preliminary analysis of the treatment for ASD, which combined HIFT capsule with standard FMT capsule, from February to December 2021 (Clinical trial Registration Number: ChiCTR2100043929). Evaluation criteria: Trypan blue staining method was used to detect the living bacteria amount in fluid and powder. The Autism Behavior Checklist (ABC) and Childhood Autism Rating Scale (CARS) were used to evaluate the efficacy. Results: Compared with the parent donor, the standard donor was younger [(25.4±0.9) y vs. (30.7±3.2) y, t=-19.097, P=0.001] and had a lower body mass index [(19.7±0.5) kg/m² vs. (20.8±1.3) kg/m², t=-8.726, P=0.001], more in the living bacteria amount in powder [(7.47±1.52)×10⁶/g vs. (5.03±1.38)×10⁶/g, t=11.331, P=0.031], Chao index (205.4±6.8 vs. 194.2±7.2, t=10.415, P=0.001), and Shannon index (3.25±0.14 vs 2.72±0.27, t=19.465, P=0.001). The differences were statistically significant (all P<0.05). However, there were no significant differences in gender, drainage volume and total number of bacterial liquid colonies between the two groups (all P>0.05). Both the standard donor and the parent donor met the donor screening criteria, and the preparation fluid and powder met the treatment criteria. Eight patients received the treatment of HIFT combined with fecal microbiota transplantation (FMT). Preliminary statistical results showed that HIFT combined with FMT improved ABC and CARS at the 1st, 2nd, 3rd and 4th months. The differences were statistically significant (all P<0.05). No severe adverse reaction occurred. Conclusion: Based on the previous research on FMT preparation system and the clinical technology in our center, this study developed a high standard HIFT preparation system, and explored the clinical study of HIFT combined with FMT, in order to provide an innovative therapy for the treatment of diseases.
Bacteria ; Child ; Fecal Microbiota Transplantation/methods* ; Glycerol ; Humans ; Powders ; Trypan Blue

Objective: To investigate the clinical efficacy of fecal microbiota transplantation (FMT) for treating steroid-refractory gastrointestinal acute graft-versus-host disease (GI-aGVHD) . Methods: This analysis included 29 patients with hematology who developed steroid-refractory GI-aGVHD after allogeneic hematopoietic stem cell transplantation (allo-HSCT) in Huaian Hospital Affiliated to Xuzhou Medical University from March 2017 to March 2022. Among them, 19 patients underwent FMT treatment (the FMT group) and 10 patients did not (the control group). The efficacy and safety of FMT were assessed, as well as the changes in intestinal microbiota abundance, lymphocyte subpopulation ratio, peripheral blood inflammatory cytokines, and GVHD biomarkers before and after FMT treatment. Results: ① Complete remission of clinical symptoms after FMT was achieved by 13 (68.4%) patients and 2 (20.0%) controls, with a statistically significant difference (P<0.05). Intestinal microbiota diversity increased and gradually recovered to normal levels after FMT and FMT-related infections did not occur. ②The proportion of CD3(+) and CD8(+) cells in the FMT group after treatment decreased compared with the control group, and the ratio of CD4(+), regulatory T cells (Treg), and CD4(+)/CD8(+) cells increased (all P< 0.05). The interleukin (IL) -6 concentration in the FMT group was lower than that in the control group [4.15 (1.91-5.71) ng/L vs 6.82 (2.40-8.91) ng/L, P=0.040], and the IL-10 concentration in the FMT group was higher than that in the control group [12.11 (5.69-20.36) ng/L vs 7.51 (4.10-9.58) ng/L, P=0.024]. Islet-derived protein 3α (REG3α) was significantly increased in patients with GI-aGVHD, and the REG3α level in the FMT group was lower than that in the control group after treatment [30.70 (10.50-105.00) μg/L vs 74.35 (33.50-139.50) μg/L, P=0.021]. Conclusion: FMT is a safe and effective method for the treatment of steroid-refractory GI-aGVHD by restoring intestinal microbiota diversity, regulating inflammatory cytokines, and upregulating Treg cells.
Humans ; Fecal Microbiota Transplantation/methods* ; Treatment Outcome ; Graft vs Host Disease/etiology* ; Hematopoietic Stem Cell Transplantation/adverse effects* ; Steroids

Toxic megacolon is a rare clinical complication of fulminant Clostridium difficile infection. The mortality rate of fulminant C. difficile infection is reported to be as high as 50%. Fecal microbiota transplantation is a highly effective treatment in patients with recurrent or refractory C. difficile infection. However, there are few published articles on the use of such transplantation for fulminant C. difficile infection. Here, we report on a patient with toxic megacolon complicated by C. difficile infection who was treated successfully with fecal microbiota transplantation.
Aged ; *Clostridium difficile ; Enterocolitis, Pseudomembranous/*complications ; Fecal Microbiota Transplantation/*methods ; Feces/*microbiology ; Humans ; Male ; Megacolon, Toxic/*microbiology/*therapy

Fecal microbiota transplantation (FMT) has become a research focus of biomedicine and clinical medicine in recent years. The clinical response from FMT for different diseases provided evidence for microbiota-host interactions associated with various disorders, including Clostridium difficile infection, inflammatory bowel disease, diabetes mellitus, cancer, liver cirrhosis, gut-brain disease and others. To discuss the experiences of using microbes to treat human diseases from ancient China to current era should be important in moving standardized FMT forward and achieving a better future. Here, we review the changing concept of microbiota transplantation from FMT to selective microbiota transplantation, methodology development of FMT and step-up FMT strategy based on literature and state experts' perspectives.
Clostridium Infections ; therapy ; Fecal Microbiota Transplantation ; methods ; standards ; Host Microbial Interactions ; Humans ; Inflammatory Bowel Diseases ; therapy ; Metabolic Diseases ; therapy

Fecal microbiota transplantation (FMT) is to transplant the functional bacteria in the feces of healthy people into the patients' intestines, rebuild the new balance of intestinal flora, and achieve the treatment goals of intestinal and extraintestinal diseases. In the past 10 years, FMT has made a breakthrough in the treatment of intestinal and extraintestinal diseases, which is highly expected to treat difficult diseases. However, due to the complexity of FMT methodology and the lack of a unified standard, there is a high heterogeneity in FMT efficacy among various researches, greatly affected its clinical application. Under the initiative of Parenteral and Enteral Nutrition Branch of Chinese Medical Association, Enhanced Recovery after Surgery Branch of China International Health Care Promotion Exchange Association, China Microecological Treatment Innovation Alliance, and Microecology Committee of Shanghai Preventive Medicine Association, the first expert consensus on standardized methodology and clinical application of FMT was established in China, with a view to improving the efficacy of FMT, reducing the incidence of adverse reactions and promoting the clinical application of FMT.
China ; Consensus ; Fecal Microbiota Transplantation ; adverse effects ; methods ; standards ; Feces ; microbiology ; Gastrointestinal Microbiome ; physiology ; Humans ; Treatment Outcome

Fecal microbiota transplantation has a 1700-year history. This forgotten treatment method has been put into use again during the last 50 years. The interest in microbiota-gut-brain axis and fecal microbiota transplantation is rapidly increasing. New evidence is obtained in the etiopathogenesis of neuropsychiatric disorders. There is a large number of experimental and clinical researches in the field of gut-brain axis. There is limited information on fecal microbiota transplantation. Despite this, initial results are promising. It is commonly used in the treatment of gastrointestinal diseases such as Clostridium difficile infection, Crohn's disease, ulcerative colitis. It is also experimentally used in the treatment of metabolic and autoimmune diseases. There are case reports that it is effective in the treatment of autism, Parkinson's disease, multiple sclerosis, chronic fatigue syndrome and irritable bowel syndrome. Its implementation is easy, and it is a cheap and reliable treatment method. However, the long-term risks are unknown. Additionally, standard application protocols have not yet been established. There are a lot of questions to be answered. A university in Turkey has got official permission this year, and started to apply fecal microbiota transplantation. In this review, neuropsychiatric areas of use of fecal microbiota transplantation have been discussed in the light of the current information.
Autistic Disorder ; Autoimmune Diseases ; Clostridium difficile ; Colitis, Ulcerative ; Crohn Disease ; Fatigue Syndrome, Chronic ; Fecal Microbiota Transplantation* ; Gastrointestinal Diseases ; Immune System ; Irritable Bowel Syndrome ; Methods ; Multiple Sclerosis ; Neurology ; Parkinson Disease ; Turkey

OBJECTIVETo evaluate the efficacy and safety of fecal microbiota transplantation (FMT) for gastrointestinal disorders.

METHODSRetrospective analysis of the clinical data of 406 patients who underwent FMT from May 2014 to April 2016 in the Intestinal Microenvironment Treatment Centre of Nanjing General Hospital was performed, including patients with constipation(276 cases), recurrent Clostridium Difficile infection (RCDI, 61 cases), ulcerative colitis(44 cases), irritable bowel syndrome (15 cases) and Crohn's disease(10 cases). Donors were completely unrelated, 18- to 50-year-old non-pregnant healthy adult, with healthy lifestyle and habits, without taking antibiotics, probiotics and other probiotics history within 3 months. There were three routes of FMT administration: patients received 6 days of frozen FMT by nasointestinal tube placed in the proximal jejunum under gastroscope (319 cases); patients received capsules FMT per day for 6 consecutive days (46 cases) or once 600 ml of treated fecal liquid infusion into colon and terminal ileum by colonoscopy(41 cases).

RESULTSClinical cure rate and improvement rate of different diseases receiving FMT were respectively as follows: RCDI was 85.2% (52/61) and 95.1%(58/61); constipation was 40.2%(111/276) and 67.4%(186/276); ulcerative colitis was 34.1%(15/44) and 68.2% (30/44); irritable bowel syndrome was 46.7% (7/15) and 73.3% (11/15) and Crohn disease was 30.0%(3/10) and 60.0%(6/10). RCDI had the best efficacy among these diseases(P<0.01). There was no significant difference between the three routes of FMT administration(P=0.829). The clinical cure rate and improvement rate of different routes were 43.3%(138/319) and 58.6% (187/319) respectively in nasogastric transplantation group, 41.5%(17/41) and 61.0%(25/41) in colonoscopy group, 37.0%(17/46) and 63.0% (29/46) in the capsule transplantation group. There was no serious adverse event during the follow-up. The most common side effects were respiratory discomfort (27.3%, 87/319) and increased venting (51.7%, 165/319) in nasogastric transplantation group. Diarrhea was the most common complication in colonoscopy group (36.6%, 15/41). The main symptoms were increased venting (50.0%, 23/46) and nausea(34.8%, 16/46) in oral capsule group. Side effect symptoms disappeared after the withdraw of nasogastric tube, or at the end of treatment, or during hospitalization for 1-3 days.

CONCLUSIONSFMT is effective for many gastrointestinal disorders. No significant adverse event is found, while the associated mechanism should be further explored.

Adult ; Clostridium Infections ; drug therapy ; Clostridium difficile ; drug effects ; Colitis, Ulcerative ; drug therapy ; Colonoscopy ; adverse effects ; methods ; Constipation ; drug therapy ; Crohn Disease ; drug therapy ; Diarrhea ; chemically induced ; Fecal Microbiota Transplantation ; methods ; statistics & numerical data ; Female ; Flatulence ; chemically induced ; Gastrointestinal Diseases ; drug therapy ; Gastroscopy ; methods ; Humans ; Intubation, Gastrointestinal ; adverse effects ; methods ; Irritable Bowel Syndrome ; drug therapy ; Male ; Middle Aged ; Nausea ; chemically induced ; Retrospective Studies ; Treatment Outcome