title: Randomized study of the effect of synbiotics during neoadjuvant chemotherapy on adverse events in esophageal cancer patients.
abstract: The clinical value of synbiotics in patients receiving neoadjuvant chemotherapy currently remains unclear. The aim of this study was to investigate the effects of synbiotics in esophageal cancer patients receiving neoadjuvant chemotherapy on the intestinal microbiota and the adverse events of chemotherapy.
  
  
  
  Sixty-one patients with advanced esophageal cancer who were scheduled to receive neoadjuvant chemotherapy were randomly allocated to 2 groups. One group received synbiotics during chemotherapy (n = 30), while the other group did not (n = 31). The fecal microbiota and organic acid concentrations were analyzed. The primary endpoint was the incidence of chemotherapy-related adverse events.
  
  
  
  The numbers of beneficial and harmful bacteria were significantly larger and smaller, respectively, in the synbiotics group than in the control group on day 10 of chemotherapy. The concentrations of acetic acid and propionic acid were significantly higher in the synbiotics group on day 10 of chemotherapy. The frequencies of severe lymphopenia and diarrhea were significantly less in the synbiotics group than in the control group (P = 0.033, 0.035, respectively). Furthermore, febrile neutropenia occurred less in the synbiotics group (10/30 in the synbiotics group vs 19/31 in the control group, P = 0.029).
  
  
  
  Synbiotics during neoadjuvant chemotherapy in esophageal cancer patients reduced the occurrence of adverse events of chemotherapy through adjustments to the intestinal microbiota. (University Hospital Medical Information Network (http://www.umin.ac.jp), registration number UMIN000006875).
authors.affiliation: Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3 Nakamichi, Higashinari-ku, Osaka, 537-8511, Japan. Electronic address: mmotoori@gh.opho.jp.
authors.forename: Masaaki
authors.initials: M
authors.lastname: Motoori
authors.affiliation: Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3 Nakamichi, Higashinari-ku, Osaka, 537-8511, Japan.
authors.forename: Masahiko
authors.initials: M
authors.lastname: Yano
authors.affiliation: Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3 Nakamichi, Higashinari-ku, Osaka, 537-8511, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Miyata
authors.affiliation: Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3 Nakamichi, Higashinari-ku, Osaka, 537-8511, Japan.
authors.forename: Keijiro
authors.initials: K
authors.lastname: Sugimura
authors.affiliation: Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3 Nakamichi, Higashinari-ku, Osaka, 537-8511, Japan.
authors.forename: Takuro
authors.initials: T
authors.lastname: Saito
authors.affiliation: Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3 Nakamichi, Higashinari-ku, Osaka, 537-8511, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Omori
authors.affiliation: Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3 Nakamichi, Higashinari-ku, Osaka, 537-8511, Japan.
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Fujiwara
authors.affiliation: Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3 Nakamichi, Higashinari-ku, Osaka, 537-8511, Japan.
authors.forename: Norikatsu
authors.initials: N
authors.lastname: Miyoshi
authors.affiliation: Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3 Nakamichi, Higashinari-ku, Osaka, 537-8511, Japan.
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Akita
authors.affiliation: Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3 Nakamichi, Higashinari-ku, Osaka, 537-8511, Japan.
authors.forename: Kunihito
authors.initials: K
authors.lastname: Gotoh
authors.affiliation: Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3 Nakamichi, Higashinari-ku, Osaka, 537-8511, Japan.
authors.forename: Hidenori
authors.initials: H
authors.lastname: Takahashi
authors.affiliation: Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3 Nakamichi, Higashinari-ku, Osaka, 537-8511, Japan.
authors.forename: Shogo
authors.initials: S
authors.lastname: Kobayashi
authors.affiliation: Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3 Nakamichi, Higashinari-ku, Osaka, 537-8511, Japan.
authors.forename: Shingo
authors.initials: S
authors.lastname: Noura
authors.affiliation: Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3 Nakamichi, Higashinari-ku, Osaka, 537-8511, Japan.
authors.forename: Masayuki
authors.initials: M
authors.lastname: Ohue
authors.affiliation: Yakult Central Institute, 1796 Yaho, Kunitachi, Tokyo, 186-8650, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Asahara
authors.affiliation: Yakult Central Institute, 1796 Yaho, Kunitachi, Tokyo, 186-8650, Japan.
authors.forename: Koji
authors.initials: K
authors.lastname: Nomoto
authors.affiliation: Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3 Nakamichi, Higashinari-ku, Osaka, 537-8511, Japan.
authors.forename: Osamu
authors.initials: O
authors.lastname: Ishikawa
authors.affiliation: Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3 Nakamichi, Higashinari-ku, Osaka, 537-8511, Japan.
authors.forename: Masato
authors.initials: M
authors.lastname: Sakon
mesh_terms: D019342:Acetic Acid / Q000032:analysis; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D000077143:Docetaxel; D023381:Endpoint Determination; D004938:Esophageal Neoplasms / Q000188:drug therapy / Q000628:therapy*; D064147:Febrile Neutropenia / Q000209:etiology / Q000517:prevention & control; D005243:Feces / Q000737:chemistry / Q000382:microbiology; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D000069196:Gastrointestinal Microbiome; D006801:Humans; D006863:Hydrogen-Ion Concentration; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000009:adverse effects*; D010349:Patient Compliance; D011422:Propionates / Q000032:analysis; D011446:Prospective Studies; D012709:Serum Albumin / Q000378:metabolism; D058616:Synbiotics / Q000008:administration & dosage*; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D055815:Young Adult
chemical_list: D011422:Propionates; D012709:Serum Albumin; D043823:Taxoids; D000077143:Docetaxel; C029658:propionic acid; D002945:Cisplatin; D019342:Acetic Acid; D005472:Fluorouracil
keywords: Adverse events; Chemotherapy; Esophageal cancer; Intestinal microbiota; Organic acids; Synbiotics