Trial Outcomes & Findings for Fecal Microbial Transplantation in Relapsing Multiple Sclerosis Patients (NCT NCT03183869)
NCT ID: NCT03183869
Last Updated: 2019-12-02
Results Overview
Luminex test to evaluate the levels of 25 cytokines in peripheral blood pre-fecal transplant and post fecal transplant. Due to early termination of the trial, we didn't meet the number of participants required for statistical analysis; therefore, we analyzed the data pre and post FMT, rather than early and late intervention groups as originally planned. Due to the small sample size there was a large variation between cytokine levels of each participant for pre and post FMT, resulting in large standard deviations.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
14 participants
Primary outcome timeframe
Within 6 months
Results posted on
2019-12-02
Participant Flow
Participant milestones
| Measure |
Early Intervention
Fecal microbiota via enema at Month 1, 2, 3. 4, 5 and month 6 along with stool, urine and blood collection. At months 7, 8, 9, 10, 11 and 12 only stool, urine and blood collection.
Fecal microbiota: fecal microbial transplantation
|
Late Intervention
At months 1, 2, 3, 4, 5 and 6, stool, urine and blood collection. Fecal microbiota via enema at month 6, 7, 8, 9, 10, 11and 12 months along with stool, urine and blood collection.
Fecal microbiota: fecal microbial transplantation
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
7
|
|
Overall Study
COMPLETED
|
0
|
2
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Early Intervention
n=4 Participants
Fecal microbiota via enema at Month 1, 2, 3. 4, 5 and month 6 along with stool, urine and blood collection. At months 7, 8, 9, 10, 11 and 12 only stool, urine and blood collection.
Fecal microbiota: fecal microbial transplantation
|
Late Intervention
n=7 Participants
At months 1, 2, 3, 4, 5 and 6, stool, urine and blood collection. Fecal microbiota via enema at month 6, 7, 8, 9, 10, 11and 12 months along with stool, urine and blood collection.
Fecal microbiota: fecal microbial transplantation
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=11 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=4 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=11 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=4 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=11 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=4 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=11 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=4 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=11 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Within 6 monthsLuminex test to evaluate the levels of 25 cytokines in peripheral blood pre-fecal transplant and post fecal transplant. Due to early termination of the trial, we didn't meet the number of participants required for statistical analysis; therefore, we analyzed the data pre and post FMT, rather than early and late intervention groups as originally planned. Due to the small sample size there was a large variation between cytokine levels of each participant for pre and post FMT, resulting in large standard deviations.
Outcome measures
| Measure |
Pre-FMT
n=10 Participants
Cytokine values before fecal microbial transplants.
Fecal microbiota: fecal microbial transplantation
|
Post-FMT
n=10 Participants
Cytokine values after fecal microbial transplants.
Fecal microbiota: fecal microbial transplantation
|
|---|---|---|
|
Effect of Fecal Microbial Transplantation in Peripheral Blood Cytokines Within Relapsing Multiple Sclerosis Patients
IL17F
|
0.082 ng/mL
Standard Deviation 0.076
|
0.093 ng/mL
Standard Deviation 0.148
|
|
Effect of Fecal Microbial Transplantation in Peripheral Blood Cytokines Within Relapsing Multiple Sclerosis Patients
GM-CSF
|
0.171 ng/mL
Standard Deviation 0.186
|
0.261 ng/mL
Standard Deviation 0.524
|
|
Effect of Fecal Microbial Transplantation in Peripheral Blood Cytokines Within Relapsing Multiple Sclerosis Patients
IFN Gamma
|
0.064 ng/mL
Standard Deviation 0.046
|
0.078 ng/mL
Standard Deviation 0.070
|
|
Effect of Fecal Microbial Transplantation in Peripheral Blood Cytokines Within Relapsing Multiple Sclerosis Patients
IL-10
|
0.026 ng/mL
Standard Deviation 0.024
|
0.024 ng/mL
Standard Deviation 0.026
|
|
Effect of Fecal Microbial Transplantation in Peripheral Blood Cytokines Within Relapsing Multiple Sclerosis Patients
MIP3 Alpha
|
0.049 ng/mL
Standard Deviation 0.035
|
0.036 ng/mL
Standard Deviation 0.023
|
|
Effect of Fecal Microbial Transplantation in Peripheral Blood Cytokines Within Relapsing Multiple Sclerosis Patients
IL-15
|
0.030 ng/mL
Standard Deviation 0.038
|
0.036 ng/mL
Standard Deviation 0.054
|
|
Effect of Fecal Microbial Transplantation in Peripheral Blood Cytokines Within Relapsing Multiple Sclerosis Patients
IL-17a
|
0.018 ng/mL
Standard Deviation 0.018
|
0.023 ng/mL
Standard Deviation 0.039
|
|
Effect of Fecal Microbial Transplantation in Peripheral Blood Cytokines Within Relapsing Multiple Sclerosis Patients
IL-22
|
0.414 ng/mL
Standard Deviation 0.443
|
0.559 ng/mL
Standard Deviation 0.811
|
|
Effect of Fecal Microbial Transplantation in Peripheral Blood Cytokines Within Relapsing Multiple Sclerosis Patients
IL-9
|
0.036 ng/mL
Standard Deviation 0.039
|
0.031 ng/mL
Standard Deviation 0.042
|
|
Effect of Fecal Microbial Transplantation in Peripheral Blood Cytokines Within Relapsing Multiple Sclerosis Patients
IL-21
|
0.042 ng/mL
Standard Deviation 0.031
|
0.040 ng/mL
Standard Deviation 0.043
|
|
Effect of Fecal Microbial Transplantation in Peripheral Blood Cytokines Within Relapsing Multiple Sclerosis Patients
IL-6
|
0.055 ng/mL
Standard Deviation 0.117
|
0.056 ng/mL
Standard Deviation 0.129
|
|
Effect of Fecal Microbial Transplantation in Peripheral Blood Cytokines Within Relapsing Multiple Sclerosis Patients
IL-17E
|
0.149 ng/mL
Standard Deviation 0.153
|
0.203 ng/mL
Standard Deviation 0.342
|
|
Effect of Fecal Microbial Transplantation in Peripheral Blood Cytokines Within Relapsing Multiple Sclerosis Patients
IL-27
|
1.534 ng/mL
Standard Deviation 0.795
|
1.792 ng/mL
Standard Deviation 1.322
|
|
Effect of Fecal Microbial Transplantation in Peripheral Blood Cytokines Within Relapsing Multiple Sclerosis Patients
IL-31
|
0.156 ng/mL
Standard Deviation 0.220
|
0.198 ng/mL
Standard Deviation 0.280
|
|
Effect of Fecal Microbial Transplantation in Peripheral Blood Cytokines Within Relapsing Multiple Sclerosis Patients
TNF alpha
|
0.042 ng/mL
Standard Deviation 0.033
|
0.053 ng/mL
Standard Deviation 0.036
|
|
Effect of Fecal Microbial Transplantation in Peripheral Blood Cytokines Within Relapsing Multiple Sclerosis Patients
TNF beta
|
0.313 ng/mL
Standard Deviation 0.585
|
0.306 ng/mL
Standard Deviation 0.627
|
|
Effect of Fecal Microbial Transplantation in Peripheral Blood Cytokines Within Relapsing Multiple Sclerosis Patients
IL-28a
|
1.190 ng/mL
Standard Deviation 2.512
|
1.704 ng/mL
Standard Deviation 2.499
|
|
Effect of Fecal Microbial Transplantation in Peripheral Blood Cytokines Within Relapsing Multiple Sclerosis Patients
IL-1 Beta
|
0.013 ng/mL
Standard Deviation 0.011
|
0.013 ng/mL
Standard Deviation 0.013
|
|
Effect of Fecal Microbial Transplantation in Peripheral Blood Cytokines Within Relapsing Multiple Sclerosis Patients
IL-33
|
0.123 ng/mL
Standard Deviation 0.097
|
0.086 ng/mL
Standard Deviation 0.114
|
|
Effect of Fecal Microbial Transplantation in Peripheral Blood Cytokines Within Relapsing Multiple Sclerosis Patients
IL-2
|
0.016 ng/mL
Standard Deviation 0.017
|
0.016 ng/mL
Standard Deviation 0.024
|
|
Effect of Fecal Microbial Transplantation in Peripheral Blood Cytokines Within Relapsing Multiple Sclerosis Patients
IL-4
|
0.428 ng/mL
Standard Deviation 0.426
|
0.425 ng/mL
Standard Deviation 0.380
|
|
Effect of Fecal Microbial Transplantation in Peripheral Blood Cytokines Within Relapsing Multiple Sclerosis Patients
IL-23
|
8.778 ng/mL
Standard Deviation 8.549
|
10.906 ng/mL
Standard Deviation 16.971
|
|
Effect of Fecal Microbial Transplantation in Peripheral Blood Cytokines Within Relapsing Multiple Sclerosis Patients
IL-5
|
0.023 ng/mL
Standard Deviation 0.021
|
0.028 ng/mL
Standard Deviation 0.026
|
|
Effect of Fecal Microbial Transplantation in Peripheral Blood Cytokines Within Relapsing Multiple Sclerosis Patients
IL-12p70
|
0.026 ng/mL
Standard Deviation 0.019
|
0.033 ng/mL
Standard Deviation 0.043
|
|
Effect of Fecal Microbial Transplantation in Peripheral Blood Cytokines Within Relapsing Multiple Sclerosis Patients
IL-13
|
0.091 ng/mL
Standard Deviation 0.186
|
0.084 ng/mL
Standard Deviation 0.181
|
SECONDARY outcome
Timeframe: Monthly for 6 monthsPCR (polymerase chain reaction) to assess blood DNA bacteria
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 monthsUrinalysis to evaluate lactulose and mannitol levels
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Monthly for 6 monthsNeurological exam using the Expanded Disability Status Scale
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 6 months and 12 monthsMRI to access subclinical disease activity
Outcome measures
Outcome data not reported
Adverse Events
Early Intervention
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Late Intervention
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Early Intervention
n=4 participants at risk
Fecal microbiota via enema at Month 1, 2, 3. 4, 5 and month 6 along with stool, urine and blood collection. At months 7, 8, 9, 10, 11 and 12 only stool, urine and blood collection.
Fecal microbiota: fecal microbial transplantation
|
Late Intervention
n=7 participants at risk
At months 1, 2, 3, 4, 5 and 6, stool, urine and blood collection. Fecal microbiota via enema at month 6, 7, 8, 9, 10, 11and 12 months along with stool, urine and blood collection.
Fecal microbiota: fecal microbial transplantation
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
75.0%
3/4 • 1 year - Nov2017 - Nov2018
|
0.00%
0/7 • 1 year - Nov2017 - Nov2018
|
|
Skin and subcutaneous tissue disorders
Hives
|
0.00%
0/4 • 1 year - Nov2017 - Nov2018
|
14.3%
1/7 • 1 year - Nov2017 - Nov2018
|
|
Cardiac disorders
Hypertension
|
0.00%
0/4 • 1 year - Nov2017 - Nov2018
|
14.3%
1/7 • 1 year - Nov2017 - Nov2018
|
|
Gastrointestinal disorders
Difficulty Swallowing
|
0.00%
0/4 • 1 year - Nov2017 - Nov2018
|
14.3%
1/7 • 1 year - Nov2017 - Nov2018
|
|
Reproductive system and breast disorders
Vaginal Yeast Infection
|
0.00%
0/4 • 1 year - Nov2017 - Nov2018
|
14.3%
1/7 • 1 year - Nov2017 - Nov2018
|
|
Ear and labyrinth disorders
Ear Infection
|
0.00%
0/4 • 1 year - Nov2017 - Nov2018
|
14.3%
1/7 • 1 year - Nov2017 - Nov2018
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place