Trial Outcomes & Findings for Implications of Fecal Microbiota Transplantation in Modulating the Effects of Liver Cirrhosis (NCT NCT06478602)
NCT ID: NCT06478602
Last Updated: 2026-03-27
Results Overview
Hepatic encephalopathy (HE) was monitored in all participants at one month after fecal microbiota transplantation (FMT) using the West Haven criteria (Grade 0-IV). Higher grades indicate more severe encephalopathy.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
19 participants
Primary outcome timeframe
At one month post-FMT.
Results posted on
2026-03-27
Participant Flow
Patients were recruited from the Sibiu County Emergency Clinical Hospital, Romania. Inclusion Criteria: * Diagnosis of liver cirrhosis according to current protocols. * Conscious and cooperative adult patients.
Liver Cirrhosis
Participant milestones
| Measure |
Fecal Microbiota Transplantation (FMT) in Patients With Liver Cirrhosis
The experimantal group will receive fecal transplantation from a healthy donor. The study results will be obtained from analyzing the progression observed in imaging and laboratory tests (blood and fecal matter) as well as the patients clinical condition - compared to the initial phase and the control group. Patients will undergo fecal transplantation using a minimum of 70 grams of material collected and tested from a healthy donor. The fecal matter will be transferred into the cecum using a colonoscope.
|
Control
The control group will include patients who will be monitored for their progress while receiving standard treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
13
|
|
Overall Study
COMPLETED
|
6
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Implications of Fecal Microbiota Transplantation in Modulating the Effects of Liver Cirrhosis
Baseline characteristics by cohort
| Measure |
Fecal Microbiota Transplantation (FMT) in Patients With Liver Cirrhosis
n=6 Participants
The experimantal group will receive fecal transplantation from a healthy donor. The study results will be obtained from analyzing the progression observed in imaging and laboratory tests (blood and fecal matter) as well as the patients clinical condition - compared to the initial phase and the control group. Patients will undergo fecal transplantation using a minimum of 70 grams of material collected and tested from a healthy donor. The fecal matter will be transferred into the cecum using a colonoscope.
Fecal microbiota transplantation: Performing a colonoscopy with fecal microbiota transplantation at the level of the cecum.
|
Control
n=13 Participants
The control group will include patients who will be monitored for their progress while receiving standard treatment.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=56 Participants
|
13 Participants
n=62 Participants
|
19 Participants
n=123 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Age, Continuous
|
54 years
n=56 Participants
|
51 years
n=62 Participants
|
51 years
n=123 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=56 Participants
|
13 Participants
n=62 Participants
|
19 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=56 Participants
|
13 Participants
n=62 Participants
|
19 Participants
n=123 Participants
|
|
Region of Enrollment
Romania
|
6 Participants
n=56 Participants
|
13 Participants
n=62 Participants
|
19 Participants
n=123 Participants
|
|
Fibrosis
|
25.95 kPa
n=56 Participants
|
22.55 kPa
n=62 Participants
|
22.55 kPa
n=123 Participants
|
|
Encephalopathy
Hepatic Encephalopathy Grade 0
|
0 Participants
n=56 Participants
|
4 Participants
n=62 Participants
|
4 Participants
n=123 Participants
|
|
Encephalopathy
Hepatic Encephalopathy Grade 1
|
5 Participants
n=56 Participants
|
7 Participants
n=62 Participants
|
12 Participants
n=123 Participants
|
|
Encephalopathy
Hepatic Encephalopathy Grade 2
|
1 Participants
n=56 Participants
|
2 Participants
n=62 Participants
|
3 Participants
n=123 Participants
|
PRIMARY outcome
Timeframe: At one month post-FMT.Liver fibrosis was assessed using transient elastography (FibroScan) one month after fecal microbiota transplantation (FMT). Liver stiffness values, expressed in kilopascals (kPa), were used to quantify fibrosis. Multiple measurements were taken per participant, and the median value was reported. Lower kPa values indicate less fibrosis (better outcome), while higher values indicate more severe fibrosis (worse outcome).
Outcome measures
| Measure |
Fecal Microbiota Transplantation (FMT) in Patients With Liver Cirrhosis
n=6 Participants
The experimantal group will receive fecal transplantation from a healthy donor. The study results will be obtained from analyzing the progression observed in imaging and laboratory tests (blood and fecal matter) as well as the patients clinical condition - compared to the initial phase and the control group. Patients will undergo fecal transplantation using a minimum of 70 grams of material collected and tested from a healthy donor. The fecal matter will be transferred into the cecum using a colonoscope.
|
Control
n=13 Participants
The control group will include patients who will be monitored for their progress while receiving standard treatment.
|
|---|---|---|
|
Liver Stiffness by Transient Elastography (FibroScan)
|
22.6 kPa
Interval 20.5 to 23.6
|
23 kPa
Interval 22.2 to 24.9
|
PRIMARY outcome
Timeframe: At one month post-FMT.Hepatic encephalopathy (HE) was monitored in all participants at one month after fecal microbiota transplantation (FMT) using the West Haven criteria (Grade 0-IV). Higher grades indicate more severe encephalopathy.
Outcome measures
| Measure |
Fecal Microbiota Transplantation (FMT) in Patients With Liver Cirrhosis
n=6 Participants
The experimantal group will receive fecal transplantation from a healthy donor. The study results will be obtained from analyzing the progression observed in imaging and laboratory tests (blood and fecal matter) as well as the patients clinical condition - compared to the initial phase and the control group. Patients will undergo fecal transplantation using a minimum of 70 grams of material collected and tested from a healthy donor. The fecal matter will be transferred into the cecum using a colonoscope.
|
Control
n=13 Participants
The control group will include patients who will be monitored for their progress while receiving standard treatment.
|
|---|---|---|
|
Implications of Fecal Microbiota Transplantation in Modulating Hepatic Encephalopathy
Hepatic Encephalopathy Grade 0
|
5 Participants
|
3 Participants
|
|
Implications of Fecal Microbiota Transplantation in Modulating Hepatic Encephalopathy
Hepatic Encephalopathy Grade 1
|
1 Participants
|
7 Participants
|
|
Implications of Fecal Microbiota Transplantation in Modulating Hepatic Encephalopathy
Hepatic Encephalopathy Grade 2
|
0 Participants
|
3 Participants
|
Adverse Events
Fecal Microbiota Transplantation (FMT) in Patients With Liver Cirrhosis
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fecal Microbiota Transplantation (FMT) in Patients With Liver Cirrhosis
n=6 participants at risk
The experimantal group will receive fecal transplantation from a healthy donor. The study results will be obtained from analyzing the progression observed in imaging and laboratory tests (blood and fecal matter) as well as the patients clinical condition - compared to the initial phase and the control group. Patients will undergo fecal transplantation using a minimum of 70 grams of material collected and tested from a healthy donor. The fecal matter will be transferred into the cecum using a colonoscope.
|
Control
n=13 participants at risk
The control group will include patients who will be monitored for their progress while receiving standard treatment.
|
|---|---|---|
|
Gastrointestinal disorders
Minor Adverse Event
|
50.0%
3/6 • Number of events 3 • Adverse events were monitored at multiple time points: 6 hours, 1 week, 1 month, and 3 months post-intervention.
Adverse events (AEs) included any untoward medical occurrence temporally associated with fecal microbiota transplantation. Serious AEs (SAEs) included life-threatening events, hospitalization, or permanent disability. AEs were collected at 6 hours, 1 week, 1 month, and 3 months. No major colonoscopy-related complications occurred.
|
0.00%
0/13 • Adverse events were monitored at multiple time points: 6 hours, 1 week, 1 month, and 3 months post-intervention.
Adverse events (AEs) included any untoward medical occurrence temporally associated with fecal microbiota transplantation. Serious AEs (SAEs) included life-threatening events, hospitalization, or permanent disability. AEs were collected at 6 hours, 1 week, 1 month, and 3 months. No major colonoscopy-related complications occurred.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place