Shortening the duration of carbapenem-resistant Enterobacteriaceae (CRE) colonization in the rectum of inpatients with fecal microbiota transplantation from unrelated healthy donors: The randomized controlled trial in King Chulalongkorn Memorial Hospital

Shortening the duration of carbapenem-resistant Enterobacteriaceae (CRE) colonization in the rectum of inpatients with fecal microbiota transplantation from unrelated healthy donors: The randomized controlled trial in King Chulalongkorn Memorial Ho

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

TCTR

Registry ID

TCTR20171223002

Enrollment

164

Registered

2017-12-23

Start date

2018-07-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gut colonization with carbapenem&#45

Interventions

filtered) 50ml of thawn fecal microbiota will be transplanted into recipients by simple enema. ,Simple enema with 50ml of normal saline

Experimental Other,Placebo Comparator No treatment

Fecal Microbiota transplantation (enema),Saline enema

Fecal microbiota will be prepared from feces of healthy volunteers and keep frozen until use. (Feces:Normal saline = 1:1&#44

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Donors (healthy volunteers, n = 60 for screeining, expected final candidates = 2-10) 18-65 years BMI 18.5-25 Recipients (n = 104) >18 years Positive of carbapenem-resistant Enterobacteriaceae (CRE) in clinical samples

Exclusion criteria

Exclusion criteria: Donors (healthy volunteers) Fever Diarrhea in the past 3 months Antibiotics treatment in the past 3 months Hospital admission in the past year Chronic diseases Cancers Long term medication Transfusion STD risks Blood tests - positive for HIV, syphilis, hepatitis viruses Stool tests - unformed stool, positive for CRE or other GI pathogens (direct exam, staining, culture, PCR) Recipients No CRE detected in rectal swab Absoulute neutrophil count < 500 cells/microliters Large intestine lesions that are not suitable for enema or rectal swab Receive antibiotics less than 48 hours Pregnancy Expected death or discharge in less than 1 week

Design outcomes

Primary

Measure	Time frame
Time to carbapenem-resistant Enterobacteriaceae eradication from stool 0-30 days days	—

Secondary

Measure	Time frame
Time to carbapenem-resistant Enterobacteriaceae infection 0-90 days days	—

Countries

Thailand

Contacts

Public ContactVoraphoj Nilaratanakul

Chulalongkorn University

voraphoj.n@chula.ac.th0827420555

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026

Shortening the duration of carbapenem&#45;resistant Enterobacteriaceae (CRE) colonization in the rectum of inpatients with fecal microbiota transplantation from unrelated healthy donors: The randomized controlled trial in King Chulalongkorn Memorial Hospital