Fosfomycin ( DrugBank: Fosfomycin )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
96クローン病1
97潰瘍性大腸炎5

96. クローン病


臨床試験数 : 2,400 薬物数 : 1,391 - (DrugBank : 267) / 標的遺伝子数 : 170 - 標的パスウェイ数 : 215
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-jRCTs031180415
01/02/201722/03/2019A trial of a combination therapy of fecal microbial transplantation and antibiotics for inflammatory bowel diseaseSingle center non-randomized study: A trial of a combination therapy of fecal microbial transplantation and antibiotics for inflammatory bowel disease Inflammatory Bowel Disease (Ulcerative Colitis, Crohn's Disease)
Inflammatory Bowel Disease (Ulcerative Colitis, Crohn's Disease)
AFM therapy arm : three antibiotics, amoxicillin (1500 mg/day), fosfomycin (3000 mg/day) and metronidazole (750 mg/day) are administered orally to patients for 2 weeks. For pediatric patients, amoxicillin (50mg/kg), fosfomycin (120mg/kg) and metronidazole (20mg/kg) are administered orally for 2 weeks (the upper limit is the same amount as adults).
FMT arm : Approximately 150 to 250 g of donor stool is diluted with saline (500 mL) and filtered to remove crude components. The diluted and filtered fecal suspension is transferred into the patients colon from cecum to rectum during total colonoscopy. As usual examinations, the patient undergoes biopsy of inflammatory site.
A-FMT arm : Patient undergoes FMT two days after AFM therapy.
Ishikawa DaiNULLRecruiting>= 6age oldNot applicableBoth120N/AJapan

97. 潰瘍性大腸炎


臨床試験数 : 2,527 薬物数 : 1,468 - (DrugBank : 259) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04979832
(ClinicalTrials.gov)
September 6, 202130/6/2021GM-CSF, Fosfomycin and Metronidazole for Pouchitis in Ulcerative Colitis Patients After Restorative IPAA SurgeryA Combined Treatment With GM-CSF, Fosfomycin and Metronidazole for Pouchitis in Ulcerative Colitis Patients After Restorative Ileal Pouch Anal Anastomosis SurgeryPouchitisDrug: GM-CSF, fosfomycin and metronidazoleZealand University HospitalNULLRecruiting18 YearsN/AAll18Phase 1/Phase 2Denmark
2EUCTR2020-000609-10-DK
(EUCTR)
06/07/202123/09/2020A combination of immunesystem stimulating- and antibiotic treatment for inflammation of the pouch in ulcerative colitis patientsA combined treatment with GM-CSF, fosfomycin and metronidazole for pouchitis in ulcerative colitis patients after restorative ileal pouch anal anastomosis surgeryA clinical safety and proof-of-concept study A combination of GM-CSF and metronidazole/fosfomycin treatment for pouchitis in Ulcerative Colitis patients after ileal-pouch-anal anastomosis surgery given as an enema or spray in the pouch.
MedDRA version: 20.0;Level: PT;Classification code 10036463;Term: Pouchitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Repomol
INN or Proposed INN: Molgramostim
Trade Name: Metronidazole
Product Name: Metronidazole
INN or Proposed INN: METRONIDAZOLE
Other descriptive name: Metronidazole
Trade Name: Fosfomycin
Product Name: Infectofos
INN or Proposed INN: Fosfomycin disodium
Other descriptive name: FOSFOMYCIN DISODIUM
Center for Surgical ScienceNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
26Phase 1;Phase 2Denmark
3JPRN-jRCTs031180415
01/02/201722/03/2019A trial of a combination therapy of fecal microbial transplantation and antibiotics for inflammatory bowel diseaseSingle center non-randomized study: A trial of a combination therapy of fecal microbial transplantation and antibiotics for inflammatory bowel disease Inflammatory Bowel Disease (Ulcerative Colitis, Crohn's Disease)
Inflammatory Bowel Disease (Ulcerative Colitis, Crohn's Disease)
AFM therapy arm : three antibiotics, amoxicillin (1500 mg/day), fosfomycin (3000 mg/day) and metronidazole (750 mg/day) are administered orally to patients for 2 weeks. For pediatric patients, amoxicillin (50mg/kg), fosfomycin (120mg/kg) and metronidazole (20mg/kg) are administered orally for 2 weeks (the upper limit is the same amount as adults).
FMT arm : Approximately 150 to 250 g of donor stool is diluted with saline (500 mL) and filtered to remove crude components. The diluted and filtered fecal suspension is transferred into the patients colon from cecum to rectum during total colonoscopy. As usual examinations, the patient undergoes biopsy of inflammatory site.
A-FMT arm : Patient undergoes FMT two days after AFM therapy.
Ishikawa DaiNULLRecruiting>= 6age oldNot applicableBoth120N/AJapan
4JPRN-UMIN000026485
2016/08/0110/03/2017Research on the Efficacy of Fecal Microbiota Transplantation and Microbiota in Japanese Children with Ulcerative Colitis. ulcerative colitisFecal Microbiota Transplantation(on Day1, 2 and 3, week 2, 3 and 5) after antibiotic pretreatment using amoxicillin 40mg/kg/day, fosfomycin 100mg/kg/day and metronidazole 16mg/kg/day.National Center for Child Health and Development10Probiotics Research Laboratory, Juntendo University Graduate School of Medicine, Tokyo, Japan. Yakult Central Institute, Tokyo, JapanRecruiting2years-old18years-oldMale and Female12Not selectedJapan
5JPRN-UMIN000009811
2013/01/2321/01/2013Comparison of randomized trials of antibiotic combination therapies for patients with ulcerative colitisComparison of randomized trials of antibiotic combination therapies for patients with ulcerative colitis - Antibiotics trials for ulcerative colitis Ulcerative colitisOne group is to receive two-week combination therapy consisting of amoxicillin (Sawacillin) 500 mg t.i.d, tetracycline (Acromycin) 500 mg t.i.d, and metronidazole (Flagyl) 250 mg t.i.d. with an inhibitor of gastric acid secretion. Patients are to be followed for 3 months (first endpoint).
Another group will receive two week combination therapy consisting of amoxicillin (Sawacillin) 500 mg t.i.d, fosfomycin (Fosmicin) 1000mg t.i.d, and metrozole (Flagyl) 250 mg t.i.d, with an inhibitor of gastric acid secretion. Patients are to be followed for 3 months.
Division of General Medicine, Department of Internal Medicine, Nihon University School of MedicineNULLComplete: follow-up complete16years-old75years-oldMale and Female40Phase 3Japan