Fecal Microbiota Transplantation After Autologous HSCT in Patients Wit
Allogeneic Fecal Microbiota Transplantation as a Consolidation Treatment After Autologous Hematopoietic Stem Cell Transplantation in Patients With Multiple Sclerosis
What it found
The trial ended early for another reason (see below).
Reason given: the bio-samples are corrupted for technical reasons
This trial finished 2 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- allogeneic fecal microbiota
What it measured
Main measures
To evaluate effectiveness of autoHSCT in combination with FMT in patients with refractory multiple sclerosis
365 days
Other measures (7)
To evaluate overall survival after autoHSCT in combination with FMT in patients with refractory multiple sclerosis
365 days
To evaluate adverse effects after FMT in immunocompromised patients
365 days
SafetyQuality of life status 1
365 days
Mood and sleepQuality of life (reported by participants)Quality of life status 2
365 days
Disability progressionWalking and mobilityQuality of life (reported by participants)Evaluation of Immune system reconstitution after autoHSCT 1
365 days
Immune responseEvaluation of Immune system reconstitution after autoHSCT 2
365 days
Immune responseImpact of autoHSCT on brain structure anatomy
365
MRI lesions
Who could take part
Relapsing and progressive · 18 to 55
Show the full criteria
Inclusion criteria
* Diagnosis: Multiple sclerosis (Relapsing-Remitting, Secondary-Progressive, Primary-Progressive) * AutoHSCT * Signed informed consent * No second tumors * No severe concurrent illness * 1.0-6.5 points by EDSS * Disease duration less than 20 years * Disease progression on 1 and/or 2 line therapy (1 point EDSS 1.0-6.0 and 0,5 point EDSS 6.0-6.5)
Exclusion criteria
* Moderate or severe cardiac dysfunction, left ventricular ejection fraction \<50% * Moderate or severe decrease in pulmonary function, FEV1 \<70% or DLCO\<70% of predicted * Respiratory distress >grade I * Severe organ dysfunction: AST or ALT >5 upper normal limits, bilirubin >1.5 upper normal limits, creatinine >2 upper normal limits * Creatinine clearance \< 60 mL/min * Uncontrolled bacterial or fungal infection at the time of enrollment * Requirement for vasopressor support at the time of enrollment * Karnofsky index \<30% * Pregnancy * Somatic or psychiatric disorder making the patient unable to sign informed consent
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The hypothesis of the study is that according to modern data, the pathogenesis of multiple sclerosis is inextricably linked to the patient's microbiota. Therefore, transplantation of a normal fecal microbiota (FMT) can improve the outcome of autologous hematopoietic stem cell transplantation (autoHSCT) by increasing the disease-free period and disease progression suspension for at least 5 years after transplantation, which meets the NEDA (No Evidence of Disease Activity) criteria, satisfying the current trends of clinical neurology.
Papers
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History
Started
Jun 2019
Main results due
Nov 2023
Finished
Nov 2023