NCT05990972

Brief Summary

Antibiotic-associated diarrhea (AAD) refers to the occurrence of other unexplained diarrhea symptoms after the use of antibiotics, often combined with abdominal pain, bloating and bloody stool. Fecal Microbiota Transplantation (FMT) is a therapeutic method to transplant the microbiota from the feces of healthy people into the intestinal tract of patients. To explore the overall efficacy and safety of FMT in the treatment of AAD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 20, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2023

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

2.8 years

First QC Date

August 7, 2023

Last Update Submit

August 7, 2023

Conditions

Fecal Microbiota TransplantationAntibiotic-associated Diarrhea

Outcome Measures

Primary Outcomes (2)

  • Changes in defecation frequency after FMT.

    Baseline and three months after treatment

  • Changes in gut microbiota after FMT.

    Baseline and three months after treatment.

Study Arms (1)

FMT group

EXPERIMENTAL
Procedure: Fecal Microbiota Transplantation

Interventions

Fecal Microbiota TransplantationPROCEDURE

Fecal Microbiota Transplantation (FMT) is a therapeutic method to transplant the microbiota from the feces of healthy people into the intestinal tract of patients. This treatment aims to improve a range of diseases associated with the gut microbiota by restoring the balance of the gut microbiota.

FMT group

Eligibility Criteria

Age21 Years - 78 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • occurrence of antibiotic-associated diarrhoea; no response to standard therapy; agree to receive FMT and sign informed consent; willingness to provide stool samples.

You may not qualify if:

  • non-antibiotic-associated diarrhea; did not accept FMT or did not sign informed consent; unwillingness to provide stool samples.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intestinal Microenvironment Treatment Center of General Surgery, Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University

Shanghai, China

Location

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • Le Wang

    Intestinal Microenvironment Treatment Center of General Surgery, Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

August 7, 2023

First Posted

August 14, 2023

Study Start

July 20, 2020

Primary Completion

April 20, 2023

Study Completion

July 20, 2023

Last Updated

August 14, 2023

Record last verified: 2023-08

Locations

CN(1)