Washed Microbiota Transplantation for The Treatment of Oncotherapy-Related Intestinal Complications
Washed Microbiota Transplantation for The Treatment of Oncotherapy-Related Intestinal Complications
Gut microbiota, known as "unrecognized organs", is closely related to the occurrence and
 development of tumors. Cancer is thought to occur secondary to local chronic inflammation.
 And some bacteria, such as Helicobacter pylori, also have direct genotoxicity, changing
 intracellular signaling pathways and thus causing abnormal cell growth. Systemic intestinal
 dysbiosis may lead to cancer, and fecal microbiota transplantation (FMT) can be a new weapon
 in anti-cancer treatment.Washed microbiota transplantation (WMT), a new stage of FMT, is
 based on the automatic microfiltration machine (GenFMTer, Nanjing, China) and the following
 repeated centrifugation plus suspension with support from specific facilities.we conducted a
 prospective, one-arm, open-label study on the efficacy and safety of WMT in the treatment of
 oncotherapy-related complications. This study aimed to exploring the therapeutic potential of
 WMT in the treatment of oncotherapy-related intestinal complications and improving the
 quality of life of patients.
Gut microbiota, known as "unrecognized organs", is closely related to the occurrence and
 development of tumors. Cancer is thought to occur secondary to local chronic inflammation.
 And some bacteria, such as Helicobacter pylori, also have direct genotoxicity, changing
 intracellular signaling pathways and thus causing abnormal cell growth. Systemic intestinal
 dysbiosis may lead to cancer, and fecal microbiota transplantation (FMT) can be a new weapon
 in anti-cancer treatment. The reduction of intestinal flora diversity may lead to intestinal
 dysbiosis, thereby reducing the body immunity and promoting the formation and development of
 neoplasm. It has been reported that FMT can be used to treat melanoma, liver cancer and
 prostate cancer after immunotherapy failed. But the mechanism of gut microbiota on the tumor
 itself remains to be further explored. In 2019, an Italian study reports the efficacy of FMT
 for diarrhea induced by tyrosine kinase inhibitors in the treatment of renal cell carcinoma,
 suggesting the therapeutic potential of gut microbiota for tumor-related gastrointestinal
 complications [1].

 Fecal Microbiota transplantation (FMT), the most classic way to treat diseases using gut
 microbiota [2], refers to the transplantation of functional microbiota in the feces of
 healthy people into the intestines of patients. It can reconstruct the overall gut microbiota
 of patients, thus treating gastrointestinal diseases and external gastrointestinal diseases
 of patients. In 2013, FMT was for the first time coined into the treatment guidelines on
 recurrent CDI, and now it plays an important role as a key treatment for clostridium
 difficile infection [3]. Washed microbiota transplantation (WMT), a new stage of FMT, is
 based on the automatic microfiltration machine (GenFMTer, Nanjing, China) and the following
 repeated centrifugation plus suspension with support from specific facilities. Compared with
 manual FMT, WMT can reduce the rate of adverse events (such as fever, diarrhea, abdominal
 pain, abdominal distension, nausea and vomiting, etc.) without affecting the efficacy. In
 addition, Zhang et al. have proved that WMT is better than the manual preparation of FMT in
 improving safety, enriching the precise amount of microbiota and quality controllable in
 practice [4]. In December 2019, A panel of 28 experts from 22 hospitals or institutes in 15
 cities has contributed to the "Nanjing consensus on methodology of washed microbiota
 transplantation" according to the international standards, and the consensus is published in
 Chinese Medical Journal in July 2020 [5].

 Therefore, we conducted a prospective, one-arm, open-label study on the efficacy and safety
 of WMT in the treatment of oncotherapy-related intestinal complications. This study aimed to
 exploring the therapeutic potential of WMT in the treatment of oncotherapy-related intestinal
 complications and improving the quality of life of patients.
Inclusion Criteria:

 -  1. Age ≥18 years old; 2. Diagnosed as malignant tumor; 3. Patients who underwent
 cancer-related treatment suffering from gastrointestinal symptoms(e.g., abdominal
 pain, diarrhea, abdominal distension, and difficulty defecating) occurred after
 standard tumor therapy (such as chemotherapy, radiation, immunotherapy, surgical
 treatment, etc.); 4. Estimated time of survival ≥ 3 months, and vital signs were
 stable); 5. Physically qualified and intended to undergo FMT;

 Exclusion Criteria:

 -  1. Patients who were pregnant or nursing; 2. Patients who were unable or unwilling to
 undergo a gastroscopy or colonoscopy; 3. Patients with cardiopulmonary failure; 4.
 Antibiotics, PPI, probiotics, and other drugs that alter gut microbiota were used in
 the previous week; 5. history of inflammatory bowel disease and intestinal symptoms
 unrelated to tumor treatment; 6.Serious uncontrolled diseases and acute infectious
 diseases；