Brief Summary

In recent years, researches illustrate that multifactorial diseases such as functional gastrointestinal disorders, autoimmune diseases, metabolic, behavioral and neurological diseases are associated with an abnormal microbiome structure-dysbiosis, which means the imbalance of the microbiome community. Fecal microbiota transplantation (FMT), the infusion of faeces from a healthy donor to the gastrointestinal tract of a recipient patient aiming to alter the intestine microbiota, is recommended to be performed in Clostridium difficile infection(CDI) as the most effective therapy. It also being used experimentally in the treatment of the disease states linked to dysbiosis of the intestinal microbiota. However, the efficacy and safety of FMT to treat the dysbiosis-associated diseases is still in its infancy. To further verify the indications above, more data is required to be collected through studies.

Trial Health

On Track

Trial Health Score

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

Enrollment

300

participants targeted

Target at P75+ for not_applicable

Timeline

8mo left

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach

1 country

1 active site

Status

recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

6 years study duration

Study Progress90%

Jan 2021Dec 2026

First Submitted

Initial submission to the registry

December 20, 2020

Completed

24 days until next milestone

First Posted

Study publicly available on registry

January 13, 2021

Completed

2 days until next milestone

Study Start

First participant enrolled

January 15, 2021

Completed

5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected

Last Updated

April 8, 2021

Status Verified

February 1, 2021

Enrollment Period

5 years

First QC Date

December 20, 2020

Last Update Submit

April 6, 2021

Conditions

Fecal Microbiota Transplantation

Outcome Measures

Primary Outcomes (1)

The efficacy of FMT in patients with gastrointestinal symptom will be assessed by the change of Gastrointestinal Symptom Rating Scale(GSRS).
Gastrointestinal Symptom Rating Scale(GSRS) is a measure of gastrointestinal symptom severity in five clusters (pain, bloating, constipation, diarrhea, and early satiety).The items are scored between 1 and 7, where 1 corresponds to "no discomfort at all" and 7 to "very severe discomfort" from the symptom. The participants will be asked to filled in the scale in several time points from baseline to 12 months after FMT.
1 year

Secondary Outcomes (1)

Number of Participants With Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events(CTCAE) V4.0
1 year

Other Outcomes (1)

Numbers of patients who have improvement in clinical symptoms (depends on each disease as stated in outcome)
1 year