PMID- 31550826
OWN - NLM
STAT- MEDLINE
DCOM- 20191018
LR  - 20191018
IS  - 1671-0274 (Print)
IS  - 1671-0274 (Linking)
VI  - 22
IP  - 9
DP  - 2019 Sep 25
TI  - [Efficacy analysis of fecal microbiota transplantation in the treatment of 2010 
      patients with intestinal disorders].
PG  - 861-868
LID - 10.3760/cma.j.issn.1671-0274.2019.09.011 [doi]
AB  - Objective: To evaluate the efficacy and safety of fecal microbiota 
      transplantation (FMT) for intestinal disorders. Methods: A retrospectively 
      descriptive cohort study was carried out. Clinical data of 2010 patients who 
      underwent FMT and received follow-up for more than 3 months from May 2014 to 
      November 2018 were collected, including 1,206 cases from Tongji University 
      Shanghai Tenth People's Hospital and 804 cases from Nanjing Eastern Military 
      General Hospital. Of the 2,010 patients, 797 were male and 1,213 were female, 
      with a mean age of (49.4+/-16.5) years old. Inclusion criteria were those with 
      indications for FMT and voluntary treatment of FMT. Pregnant or lactating women, 
      patients with end-stage disease, cases who were participating or participated in 
      other clinical trials within 3 months, and patients with previous bowel history 
      of pathogen infection, oral antibiotics or proton pump inhibitors (PPI) for the 
      recent2 weeks, and those at immunosuppressive state were excluded. Informed 
      consent was obtained from the enrolled patients and their families. There were 
      1,356 cases of constipation, 175 cases of inflammatory bowel disease, 148 cases 
      of chronic diarrhea, 127 cases of radiation enteritis, 119 cases of irritable 
      bowel syndrome, and 85 cases of autism (complicating with intestinal disorders). 
      FMT donor requirements: (1) 18 to 30 years old non-relatives, non-pregnant 
      healthy adults with healthy lifestyle and good eating habits as volunteers to 
      participate in fecal donation; (2) no administration of antibiotics within 3 
      months; (3) no chronic diseases such as constipation, irritable bowel syndrome, 
      inflammatory bowel disease, etc., no autoimmune disease, not in immunosuppressive 
      state, no history of malignant disease; (4) negative pathogen examination of 
      infectious diseases (hepatitis B virus, hepatitis C virus, syphilis, HIV, etc.); 
      (5) negative fecal examination (C.difficile, dysentery bacillus, Shigella, 
      Campylobacter, parasites, etc.). The donor requirements after enrollment: (1) 
      physical examination was reviewed once every two months, and the result still met 
      the above requirements; (2) 16S rRNA sequencing was performed for every fecal 
      donation in order to ensure that the composition and diversity of the fecal flora 
      was stable and reliable. The preparation of the stool suspension referred to the 
      Amsterdam criteria and the preparation process was less than 1 hour. The 
      preparation of the FMT capsule was processed by pre-freezing the stool suspension 
      after the preparation of the above suspension, and the frozen sample was 
      transferred into a freeze dryer for freezing. The dried and lyophilized powder 
      was encapsulated in capsules, and the capsule shell was made of acid-resistant 
      hypromellose capsule (No.0) and pediatric-specific capsule (No.3), sealed and 
      packaged in a-20℃ refrigerator. Three ways of accepting FMT treatment pathways 
      included 6-day transplantation after the placement of the nasointestinal tube, 
      6-day oral FMT capsule transplantation and one-time transplantation through 
      colonoscopy. Intestinal preparation (nasointestinal tube feeding of polyethylene 
      glycol until watery stool) was carried out before transplantation. Other 
      treatments were stopped during treatment and follow-up, and any medication was 
      not recommended when necessary. Results: Of the 2010 patients, 1,497 cases 
      received nasointestinal tube transplantation (nasointestinal tube group), 452 
      cases oral capsule transplantation (oral capsule group) and 61 cases colonoscopy 
      (colonoscopy group). At 3 time points of 3, 12, and 36 months after FMT, the 
      clinical cure rates and the clinical improvement rates were 41.3% (560/1 356), 
      35.2% (320/909), 31.4% (69/220), and 29.0% (393/1 356), 27.8% (253/909), 29.1% 
      (64/220), respectively in constipation patients; 33.1% (58/175), 29.9% (35/117), 
      24.5% (12/49), and 31.4% (55/175), 27.4% (32/117), 57.1% (28/49), respectively in 
      inflammatory bowel disease patients; 87.8% (130/148), 81.8% (81/99), 78.3% 
      (36/46), and 8.1% (12/148), 7.1% (7/99), 4.3% (2/46), respectively in chronic 
      diarrhea patients; 61.4% (78/127), 56.5% (48/85), 47.6% (20/42), and 21.2% 
      (27/127), 15.3% (13/85), 14.3% (6/42), respectively in radiation enteritis 
      patients; 53.8% (64/119), 45.0% (36/80), 6/15, and 21.0% (25/119), 26.2% (21/80), 
      4/15, respectively in irritable bowel syndrome patients; 23.5% (20/85), 22.8% 
      (13/57), 20.0%(5/25), and 55.3% (47/85), 49.1% (28/57), 40.0% (10/25), 
      respectively in autism patients. Meanwhile the clinical cure rates and the 
      clinical improvement rates at 3, 12, and 36 months were 47.7% (714/1 497), 42.8% 
      (425/994), 39.1% (128/327), and 29.1% (436/1 497), 27.0% (268/994), 28.1% 
      (92/327), respectively in the nasointestinal tube group; 38.7% (175/452), 30.2% 
      (91/301), 33.3% (16/48), and 24.3% (110/452), 26.2% (79/301), 25.0% (12/48), 
      respectively in the oral capsule group; 34.4% (21/61), 32.7% (17/52), 18.2% 
      (4/22), and 21.3% (13/61), 13.5% (7/52), 45.5% (10/22), respectively in 
      colonoscopy group. No serious adverse events occurred during treatment and 
      follow-up period. The adverse event of nasointestinal tube group presented higher 
      ratio of discomfort in respiratorytract accounting for 13.1% (196/1497); the oral 
      capsule group had a higher proportion of nausea and vomiting when swallowing 
      capsules accounting for 7.1% (32/452); the colonoscopy group was mainly diarrhea, 
      accounting for 37.7% (23/61). The above symptoms disappeared after the 
      nasointestinal tube was removed, or after treatment ended, or within 1 to 3 days 
      after hospitalization. Conclusion: FMT is a safe and effective method for the 
      treatment of intestinal dysfunction.
FAU - Li, N
AU  - Li N
AD  - Intestinal Microenvironment Treatment Center, Tenth People's Hospital, Medical 
      School of Tongji University, Shanghai 200072, China; Department of General 
      Surgery, Nanjing Eastern Military General Hospital, Nanjing 210002, China.
FAU - Tian, H L
AU  - Tian HL
AD  - Intestinal Microenvironment Treatment Center, Tenth People's Hospital, Medical 
      School of Tongji University, Shanghai 200072, China.
FAU - Chen, Q Y
AU  - Chen QY
AD  - Intestinal Microenvironment Treatment Center, Tenth People's Hospital, Medical 
      School of Tongji University, Shanghai 200072, China.
FAU - Yang, B
AU  - Yang B
AD  - Intestinal Microenvironment Treatment Center, Tenth People's Hospital, Medical 
      School of Tongji University, Shanghai 200072, China.
FAU - Ma, C L
AU  - Ma CL
AD  - Intestinal Microenvironment Treatment Center, Tenth People's Hospital, Medical 
      School of Tongji University, Shanghai 200072, China.
FAU - Lin, Z L
AU  - Lin ZL
AD  - Intestinal Microenvironment Treatment Center, Tenth People's Hospital, Medical 
      School of Tongji University, Shanghai 200072, China.
FAU - Zhang, X Y
AU  - Zhang XY
AD  - Department of Surgery, Medical School of Tongji University, Shanghai 200072, 
      China.
FAU - Zhao, D
AU  - Zhao D
AD  - Intestinal Microenvironment Treatment Center, Tenth People's Hospital, Medical 
      School of Tongji University, Shanghai 200072, China.
FAU - Huang, Z X
AU  - Huang ZX
AD  - Department of Surgery, Medical School of Tongji University, Shanghai 200072, 
      China.
FAU - Jiang, J
AU  - Jiang J
AD  - Department of General Surgery, Nanjing Eastern Military General Hospital, Nanjing 
      210002, China.
FAU - Qin, H L
AU  - Qin HL
AD  - Intestinal Microenvironment Treatment Center, Tenth People's Hospital, Medical 
      School of Tongji University, Shanghai 200072, China.
LA  - chi
GR  - 81670493/National Natural Science Foundation of China/
GR  - 04.99.18001/Special Fund for the Construction of the Clinical Center of Tenth 
      People's Hospital of Tongji University/
PT  - Journal Article
PL  - China
TA  - Zhonghua Wei Chang Wai Ke Za Zhi
JT  - Zhonghua wei chang wai ke za zhi = Chinese journal of gastrointestinal surgery
JID - 101177990
RN  - 0 (RNA, Ribosomal, 16S)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Bacteria/genetics
MH  - China
MH  - Cohort Studies
MH  - *Fecal Microbiota Transplantation
MH  - Feces/microbiology
MH  - Female
MH  - Humans
MH  - *Intestinal Diseases/therapy
MH  - Male
MH  - Middle Aged
MH  - RNA, Ribosomal, 16S
MH  - Retrospective Studies
MH  - Treatment Outcome
MH  - Young Adult
OTO - NOTNLM
OT  - Fecal microbiota transplantation
OT  - Gastrointestinal disorders
OT  - Intestinal microenvironment treatment
EDAT- 2019/09/26 06:00
MHDA- 2019/10/19 06:00
CRDT- 2019/09/25 06:00
PHST- 2019/09/25 06:00 [entrez]
PHST- 2019/09/26 06:00 [pubmed]
PHST- 2019/10/19 06:00 [medline]
AID - 10.3760/cma.j.issn.1671-0274.2019.09.011 [doi]
PST - ppublish
SO  - Zhonghua Wei Chang Wai Ke Za Zhi. 2019 Sep 25;22(9):861-868. doi: 
      10.3760/cma.j.issn.1671-0274.2019.09.011.