Trial Outcomes & Findings for Fecal Microbiota Transplantation for Pancreatitis (NCT NCT02318134)
NCT ID: NCT02318134
Last Updated: 2021-04-14
Results Overview
The recovery of gastrointestinal dysfunction was assessed by gastrointectinal failure score. Gastrointestinal failure score is a comprehensive score for assessing gastrointestinal function. Gastrointestinal dysfunction score gets o point meaning enteral nutrition\> 50% of the required amount and no intra-abdominal hypertension. GIF score range from 0 to 4, and higher scores mean a worse outcome.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
one week after intervention
Results posted on
2021-04-14
Participant Flow
Participants were recruited between November 2017 and April 2019 from the intensive unit care, Department of Gastroenterology, First Affiliated Hospital of Nanchang University.
Participant milestones
| Measure |
FMT Group
In the FMT group, participants received 200 mL fresh donor feces for twice (once every two days) via a nasoduodenal tube.
|
Control Group
In the control group, participants received 200 mL normal saline for twice (once every two days) via a nasoduodenal tube.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
28
|
29
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
FMT Group
In the FMT group, participants received 200 mL fresh donor feces for twice (once every two days) via a nasoduodenal tube.
|
Control Group
In the control group, participants received 200 mL normal saline for twice (once every two days) via a nasoduodenal tube.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
Fecal Microbiota Transplantation for Pancreatitis
Baseline characteristics by cohort
| Measure |
FMT Group
n=30 Participants
In the FMT group, participants received 200 mL fresh donor feces for twice (once every two days) via a nasoduodenal tube.
|
Control Group
n=30 Participants
In the control group, participants received 200 mL normal saline for twice (once every two days) via a nasoduodenal tube.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.2 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
49.9 years
STANDARD_DEVIATION 13.7 • n=7 Participants
|
48.6 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
BMI
|
26.3 kg/m^2
STANDARD_DEVIATION 3.7 • n=5 Participants
|
25.6 kg/m^2
STANDARD_DEVIATION 4.2 • n=7 Participants
|
26.0 kg/m^2
STANDARD_DEVIATION 3.9 • n=5 Participants
|
|
Causes of pancreatitis
Biliary
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Causes of pancreatitis
Alcohol
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Causes of pancreatitis
Hypertriglyceridemia
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Causes of pancreatitis
Other
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Smoker
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Drinker
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Iintra-abdominal pressure
|
13.7 mmHg
STANDARD_DEVIATION 2.4 • n=5 Participants
|
14.5 mmHg
STANDARD_DEVIATION 2.5 • n=7 Participants
|
14.1 mmHg
STANDARD_DEVIATION 2.5 • n=5 Participants
|
|
Time from first symptoms to admission
|
3 days
n=5 Participants
|
3 days
n=7 Participants
|
3 days
n=5 Participants
|
|
Time from admission to intervention
|
2 days
n=5 Participants
|
1.5 days
n=7 Participants
|
2 days
n=5 Participants
|
PRIMARY outcome
Timeframe: one week after interventionThe recovery of gastrointestinal dysfunction was assessed by gastrointectinal failure score. Gastrointestinal failure score is a comprehensive score for assessing gastrointestinal function. Gastrointestinal dysfunction score gets o point meaning enteral nutrition\> 50% of the required amount and no intra-abdominal hypertension. GIF score range from 0 to 4, and higher scores mean a worse outcome.
Outcome measures
| Measure |
Control Group
n=30 Participants
In the control group, participants received 200 mL normal saline for twice (once every two days) via a nasoduodenal tube.
|
FMT Group
n=30 Participants
In the FMT group, participants received 200 mL fresh donor feces for twice (once every two days) via a nasoduodenal tube.
|
|---|---|---|
|
Number of Participants With Gastrointestinal Failure Score Equal 0
|
14 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 120 daysThe incidence of any infectious complications，such as infected pancreatic necrosis, infected ascites, bacteraemia, pneumonia, urinary tract infection.
Outcome measures
| Measure |
Control Group
n=30 Participants
In the control group, participants received 200 mL normal saline for twice (once every two days) via a nasoduodenal tube.
|
FMT Group
n=30 Participants
In the FMT group, participants received 200 mL fresh donor feces for twice (once every two days) via a nasoduodenal tube.
|
|---|---|---|
|
Number of Participants With Infectious Complications
Any infectious complications
|
16 Participants
|
15 Participants
|
|
Number of Participants With Infectious Complications
Documented IPN
|
8 Participants
|
4 Participants
|
|
Number of Participants With Infectious Complications
Suspected or documented IPN
|
9 Participants
|
10 Participants
|
|
Number of Participants With Infectious Complications
infected ascites
|
2 Participants
|
2 Participants
|
|
Number of Participants With Infectious Complications
bacteremia
|
10 Participants
|
9 Participants
|
|
Number of Participants With Infectious Complications
pneumonia
|
8 Participants
|
6 Participants
|
|
Number of Participants With Infectious Complications
Urinary tract infection
|
7 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 120 daysThe incidence of organ failure,such as respiratory failure, renal failure, circulatory failure.
Outcome measures
| Measure |
Control Group
n=30 Participants
In the control group, participants received 200 mL normal saline for twice (once every two days) via a nasoduodenal tube.
|
FMT Group
n=30 Participants
In the FMT group, participants received 200 mL fresh donor feces for twice (once every two days) via a nasoduodenal tube.
|
|---|---|---|
|
Number of Participants With Organ Failure
Any persistent organ failure
|
23 Participants
|
24 Participants
|
|
Number of Participants With Organ Failure
Persistent respiratory failure
|
21 Participants
|
24 Participants
|
|
Number of Participants With Organ Failure
Persistent renal failure
|
5 Participants
|
3 Participants
|
|
Number of Participants With Organ Failure
Persistent circulatory failure
|
11 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 120 daysnumber of patients who need extra interventions or surgery
Outcome measures
| Measure |
Control Group
n=30 Participants
In the control group, participants received 200 mL normal saline for twice (once every two days) via a nasoduodenal tube.
|
FMT Group
n=30 Participants
In the FMT group, participants received 200 mL fresh donor feces for twice (once every two days) via a nasoduodenal tube.
|
|---|---|---|
|
Number of Participants With Interventions or Surgery
Percutaneous or endoscopic transmural drainage
|
11 Participants
|
10 Participants
|
|
Number of Participants With Interventions or Surgery
Percutaneous or endoscopic transmural necrosectomy
|
7 Participants
|
6 Participants
|
|
Number of Participants With Interventions or Surgery
Open surgery
|
1 Participants
|
1 Participants
|
|
Number of Participants With Interventions or Surgery
Mechanical ventilation
|
10 Participants
|
12 Participants
|
|
Number of Participants With Interventions or Surgery
Renal replacement therapy
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 6 monthspatients' Length of Intensive care time and hospital stay due to the disease
Outcome measures
| Measure |
Control Group
n=30 Participants
In the control group, participants received 200 mL normal saline for twice (once every two days) via a nasoduodenal tube.
|
FMT Group
n=30 Participants
In the FMT group, participants received 200 mL fresh donor feces for twice (once every two days) via a nasoduodenal tube.
|
|---|---|---|
|
Length of Intensive Care Time and Hospital Stay
Intensive care stay
|
11 days
Interval 2.0 to 43.0
|
9 days
Interval 3.0 to 103.0
|
|
Length of Intensive Care Time and Hospital Stay
Hospital stay
|
23 days
Interval 5.0 to 125.0
|
18.5 days
Interval 9.0 to 122.0
|
SECONDARY outcome
Timeframe: 120 dayspatients who die due to the diseases
Outcome measures
| Measure |
Control Group
n=30 Participants
In the control group, participants received 200 mL normal saline for twice (once every two days) via a nasoduodenal tube.
|
FMT Group
n=30 Participants
In the FMT group, participants received 200 mL fresh donor feces for twice (once every two days) via a nasoduodenal tube.
|
|---|---|---|
|
Mortality
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: one week after interventionPlasma Diamine oxidase（DAO）level as a predictor in the diagnosis of Intestinal mucosal barrier injury. The rate of decline in DAO was calculated by ((value before intervention - value one week after intervention)/ value before intervention)\*100)
Outcome measures
| Measure |
Control Group
n=30 Participants
In the control group, participants received 200 mL normal saline for twice (once every two days) via a nasoduodenal tube.
|
FMT Group
n=30 Participants
In the FMT group, participants received 200 mL fresh donor feces for twice (once every two days) via a nasoduodenal tube.
|
|---|---|---|
|
Diamine Oxidase（DAO）
|
-0.05 percent change of DAO
Interval -4.32 to 0.78
|
-0.21 percent change of DAO
Interval -46.2 to 0.57
|
SECONDARY outcome
Timeframe: one week after interventionPlasma D-lactate level as a predictor in the diagnosis of Intestinal mucosal. The rate of decline in D-lactate was calculated by ((value before intervention - value one week after intervention)/ value before intervention)\*100).
Outcome measures
| Measure |
Control Group
n=30 Participants
In the control group, participants received 200 mL normal saline for twice (once every two days) via a nasoduodenal tube.
|
FMT Group
n=30 Participants
In the FMT group, participants received 200 mL fresh donor feces for twice (once every two days) via a nasoduodenal tube.
|
|---|---|---|
|
D-lactate
|
-0.28 percent change of D-lactate
Interval -3.72 to 0.75
|
0.37 percent change of D-lactate
Interval -1.06 to 0.85
|
Adverse Events
FMT Group
Serious events: 24 serious events
Other events: 25 other events
Deaths: 3 deaths
Control Group
Serious events: 24 serious events
Other events: 25 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
FMT Group
n=30 participants at risk
In the FMT group, participants received 200 mL fresh donor feces for twice (once every two days) via a nasoduodenal tube.
|
Control Group
n=30 participants at risk
In the control group, participants received 200 mL normal saline for twice (once every two days) via a nasoduodenal tube.
|
|---|---|---|
|
Infections and infestations
Infected pancreatic necrosis
|
13.3%
4/30 • Number of events 4 • 10 months
|
26.7%
8/30 • Number of events 8 • 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Persistent respiratory failure
|
80.0%
24/30 • Number of events 24 • 10 months
|
70.0%
21/30 • Number of events 21 • 10 months
|
|
Renal and urinary disorders
Persistent renal failure
|
10.0%
3/30 • Number of events 3 • 10 months
|
16.7%
5/30 • Number of events 5 • 10 months
|
|
Cardiac disorders
Persistent circulatory failure
|
30.0%
9/30 • Number of events 9 • 10 months
|
36.7%
11/30 • Number of events 11 • 10 months
|
|
Gastrointestinal disorders
gastrointestinal fistula
|
3.3%
1/30 • Number of events 1 • 10 months
|
3.3%
1/30 • Number of events 1 • 10 months
|
|
Gastrointestinal disorders
intra-abdominal bleeding
|
6.7%
2/30 • Number of events 2 • 10 months
|
0.00%
0/30 • 10 months
|
|
Gastrointestinal disorders
gastrointestinal bleeding
|
6.7%
2/30 • Number of events 2 • 10 months
|
3.3%
1/30 • Number of events 1 • 10 months
|
|
Gastrointestinal disorders
gastrointestinal perforation
|
0.00%
0/30 • 10 months
|
3.3%
1/30 • Number of events 1 • 10 months
|
Other adverse events
| Measure |
FMT Group
n=30 participants at risk
In the FMT group, participants received 200 mL fresh donor feces for twice (once every two days) via a nasoduodenal tube.
|
Control Group
n=30 participants at risk
In the control group, participants received 200 mL normal saline for twice (once every two days) via a nasoduodenal tube.
|
|---|---|---|
|
Infections and infestations
infected ascites
|
6.7%
2/30 • Number of events 2 • 10 months
|
6.7%
2/30 • Number of events 2 • 10 months
|
|
Infections and infestations
Bacteraemia
|
30.0%
9/30 • Number of events 9 • 10 months
|
33.3%
10/30 • Number of events 10 • 10 months
|
|
Infections and infestations
pneumonia
|
20.0%
6/30 • Number of events 6 • 10 months
|
26.7%
8/30 • Number of events 8 • 10 months
|
|
Infections and infestations
Urinary tract infection
|
10.0%
3/30 • Number of events 3 • 10 months
|
23.3%
7/30 • Number of events 7 • 10 months
|
|
Gastrointestinal disorders
bloating
|
83.3%
25/30 • Number of events 25 • 10 months
|
80.0%
24/30 • Number of events 24 • 10 months
|
|
Gastrointestinal disorders
vomiting
|
3.3%
1/30 • Number of events 1 • 10 months
|
0.00%
0/30 • 10 months
|
Additional Information
Dr. Ling Ding
First Affiliated Hospital of Nanchang University
Phone: 15279196058
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place