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China's security data demystified
) or the lower gastrointestinal route (colonoscopy, sigmoidoscopy, ostomy, enema, etc.
) into the patient's intestine, so that it can multiply in the patient's intestine, so that the structure of the patient's intestinal flora changes, changes the microecology of the patient's intestine, and finally achieves the purpose
of alleviating and curing the patient's disease.
Figure 1 Source: Ruijing Since the technology and concept of treating diseases by interfering
with the intestinal flora are relatively new, clinicians and patients are particularly concerned about treatment safety
.
The Lancet Gastroenterology & Hepatology published a follow-up study of FMT in large samples of FMT by the Colorectal Specialist/Intestinal Microecology Diagnosis and Treatment Center of Shanghai Tenth People's Hospital and Shanghai Tongji FMT Working Group, which discussed the long-term safety of FMT in the treatment of a variety of intestinal diseases in China
.
Figure 2 Screenshots
of source literature with 5-year follow-up, how safe is FMT? The study included 8547 patients
who underwent FMT at Shanghai Tenth People's Hospital between January 1, 2012 and September 30, 2021.
Patients were followed up with questionnaires at 2 weeks, 3 months, 1 year, and 5 years after FMT treatment to assess adverse events associated with FMT and newly diagnosed diseases or symptoms
.
The response rates to the survey were 95.
2%, 85.
4%, 64.
9% and 41.
9%
respectively.
There were four methods of FMT administration: fresh frozen healthy donor fecal material delivered through a nasogastric tube placed proximal to the jejunum (6224 patients), oral capsules daily for 6 consecutive days (1543 patients), single fecal fluid infusion by colonoscopy (458 patients), and single enema (322 patients).
The total dose of FMT given to patients is the same regardless of the
route of administration.
Fig.
3 Source: Ruijing
▌ Adverse events were mild to moderate, and most of the adverse events that occurred during the short and short-term
follow-up (2 weeks) were related
to the FMT administration method.
- Nasogastric tube: the most common adverse events were nasogastric tube-related dyspnea and nausea and vomiting
. - Oral capsule group: The most common adverse events were nausea and vomiting, which are due to fecal odors and tastes
that are difficult to completely remove during oral administration. - Colonoscopy and enema: the most common adverse events were diarrhoea and perianal discomfort
.
These adverse events were mild or moderate and occurred briefly
.
Figure 2 Screenshot
of source literature ▌ New diseases and symptoms did not increase
During the 5-year follow-up period, 248 new diseases or symptoms were reported in 1034 patients, the most common being gastrointestinal diseases and respiratory diseases
。 The researchers compared the incidence of new-onset disease in patients receiving FMT with the incidence of the general population nationwide and found no significant difference
in incidence between the two groups.
During follow-up, no FMT-related transmission events were identified, and none of the deaths were directly attributable to FMT treatment
.
It follows that FMT treatment is safe
at both short-term and long-term follow-up.
Tongji fecal flora transplantation safety standard, 6 dimensions to improve safety In order to further standardize the indications and administration time of FMT treatment and improve the safety of FMT, the research team proposed the "Tongji Fecal Microbiota Transplantation Safety Specification"
.
The "Safety Specification for Tongji Fecal Microbiota Transplantation" includes informed consent, strict donor screening management, safety management of transplant fluid, assessment of patient transplantation, safety of transplantation route, and emergency handling plan of transplantation process, which improves the safety of
FMT treatment from six dimensions.
This safety specification has been implemented
since 2019 in the Colorectal Specialty/Intestinal Microecology Diagnosis and Treatment Center of Shanghai Tenth People's Hospital.
After 2 years of implementation, the researchers found that the implementation of the norm was associated with a reduction in the incidence of adverse events, from 32.
6% to 17.
2%
in the short term (i.
e.
, within 2 weeks).
In addition, patient satisfaction increased from 82.
5% to 95.
6%.
In summary, FMT has a good short- and long-term safety profile and does not increase the risk of transmission of infection and the risk of
emerging diseases.
The "Safety Code for Fecal Microbiota Transplantation in Tongji" can effectively reduce the incidence
of adverse events of FMT.
Expert reviews
At present, the safety concerns of FMT include: 1.
screening and management of standard donors; 2.
preparation and quality control of grafts; 3.
selection
of receptor indications.
During the research, our team followed:
1.
Donors are the source of FMT safety and effectiveness
.
It puts forward extremely high requirements for the screening and management of donors, including family genetic history, donor intestinal flora balance, infectious diseases, parasites, drug-resistant bacteria, drug resistance genes and genetic detection, strict assessment of the physiological, psychological, stable and other conditions of the donor, in addition to screening, but also its full-cycle management
.
Based on the long-term follow-up results of 10,000 cases of FMT clinical data and the experience of donor screening of more than 9,000 cases, combined with the clinical data and guidelines of international RCTs, our team formulated the "Tongji Fecal Microbiota Transplantation Safety Specification", which was confirmed by the study Reduce the incidence of adverse events associated with FMT.
2.
Efficient graft preparation and quality control are important factors
to ensure clinical safety and effectiveness.
3.
Select the recipient according to the recommendation of "Establishment of Standardized Methodology of Microbiota Transplantation and Common Knowledge of Clinical Chinese Experts".
In order to ensure the safety and effectiveness of FMT, the following points also need to be paid attention to when carrying out FMT:
- Have a deep understanding of the causal relationship between intestinal flora and disease, and avoid clinical dare not use or abuse due to insufficient understanding;
- Except for recurrent CDI, the treatment of any disease should be carried out as a clinical study, and the design should be reasonable, standardized, rigorous, detailed data, and long-term follow-up results;
- Standardized graft management, so that the graft information can be traced after transplantation;
- The selection of transplantation routes was reasonable (see the Chinese Expert Consensus on the Establishment and Selection of Microbiota Transplantation Routes for Clinical Application);
- Addressing the legality of FMT locally includes ethics, technical access filing, fees, etc
.
In addition, the strength of evidence-based medical evidence in this study is not enough, more single-disease single-center or multi-center prospective randomized controlled studies are needed for further confirmation, our team has launched a national multi-center randomized double-blind controlled study including microbiota transplantation for the treatment of autism, a national multi-center study of microbiota transplantation for IBS and constipation combined with Parkinson's disease, and it is expected that these results can guide the correct research direction
of our clinic.
Expert profiles
Professor Chen Qiyi
- Executive Director of Colorectal Disease Specialty/Intestinal Microecology Diagnosis and Treatment Center, Shanghai Tenth People's Hospital, Deputy Chief Physician, Medical Doctor, Postdoctoral
Fellow of Chinese Academy of Sciences. - Leader of the Intestinal Microecology Collaboration Group of Parenteral Enteral Nutrition Branch of Chinese Medical Association, Vice Chairman of the Clinical Nutritionist Committee of Surgeon Branch of Chinese Medical Doctor Association, Member of the Standing Committee of Intestinal Microecology and Intestinal Bacteria Transplantation Committee of Human Health Science and Technology Promotion Committee, Deputy Director
of Shanghai Engineering Technology Center for Human Intestinal Microbiota Development and Research and Clinical Research Center for Digestive Diseases of Tongji University. - In 2012, he began to engage in the medical and surgical treatment of complex intestinal dysfunction diseases, and led the development and international exchanges
of domestic microbiota transplantation as the national standard setter of domestic intestinal flora transplantation. - He published 42 papers as the first author/corresponding author, including 32 SCI papers, with the highest impact factor of 45 points
.
References:
[1] Tian H,Zhang S,Qin H,et al.
Long-term safety of faecal microbiota transplantation for gastrointestinal diseases in China.
Lancet Gastroenterol Hepatol.
2022 Aug; 7(8):702-703.
doi:10.
1016/S2468-1253(22)00170-4.
[2] Zang Siyuan, Liu Yuedong.
Research progress of ulcerative colitis and fecal microbiota transplantation[J].
Journal of Liaoning University of Chinese Medicine,2018,20(11):101-104.
)
