Fecal Microbiota Transplantation Effect on Amyotrophic Lateral Sclerosis Patients
NCT ID: NCT03766321
Last Updated: 2024-08-27
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
NA
Total Enrollment
42 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-07-01
Study Completion Date
2025-02-28
Brief Summary
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Given the role of adaptive immunity in ALS, the pathogenicity of some clostridial strains on motorneurons, the putative role of cyanobacteria in ALS development, and the increasing interest for microbiota in neurodegenerative disorders, the modification of intestinal microbiota might affect ALS at its core.
This interventional study aims at evaluating the biological and disease-modifying effects of Fecal Microbiota Transplant (FMT) in patients affected by Amyotrophic Lateral Sclerosis. As a primary aim of the study, the investigators postulate ALS patients treated with FMT compared to the control arm will display increased Tregs number, which is a favourable biomarker of disease activity and progression. Clinical outcomes as disease progression measured by ALS Functional Rating Scale Revised (ALSFRS-R) score, survival, respiratory function and quality of life will be assessed during the whole treatment and follow-up period.
Moreover, biological activity of FMT will be evaluated in different biomatrices, together with FMT safety and tolerability in a cohort of ALS patients.
This interventional study aims at evaluating the biological and disease-modifying effects of Fecal Microbiota Transplant (FMT) in patients affected by Amyotrophic Lateral Sclerosis. As a primary aim of the study, the investigators postulate ALS patients treated with FMT compared to the control arm will display increased Tregs number, which is a favourable biomarker of disease activity and progression. Clinical outcomes as disease progression measured by ALS Functional Rating Scale Revised (ALSFRS-R) score, survival, respiratory function and quality of life will be assessed during the whole treatment and follow-up period.
Moreover, biological activity of FMT will be evaluated in different biomatrices, together with FMT safety and tolerability in a cohort of ALS patients.
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Detailed Description
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The study will include 42 ALS patients with 2:1 allocation in 2 groups of subjects (28 FMT vs 14 placebo); computerized randomization will be stratified by progression rate (ΔFS) \</≥0.7. Randomization time will last 18 months. Treatment will be double blinded to patients and physicians, and will be done at baseline and at month 6. FMT is regarded as the active treatment. Post-treatment follow up will be 6 months.
ALS patients will undergo upper GI endoscopy with small-intestine biopsies (n° 4 biopsies of small intestine, performed with a standard biopsy forces) at baseline and after 6 months. At baseline patients will be randomized (2:1) to either an allogenic (from donors) infusion of collected feces (fecal microbiota transplantation, FMT) (or no procedure in case of allocation to placebo) in the duodenum-jejunum. The infusion will be performed through a standard nasojejunal tube, that will be placed during endoscopy. Infusion of feces will be performed at time 0 and repeated at month 6. The patients allocated to placebo arm will not receive treatment, but will undergo intestinal biopsy.
Upper GI endoscopy 12 months after FMT will be performed only to identify specific microbioma and mucosal immunological evaluation. Fecal samples and small intestine biopsy samples (at baseline, before treatment, and at month 6 and 12) will be obtained from patients to perform the gut microbiota typing.
Every endoscopic procedure will be performed with sedation of the patient. Feces for FMT will be obtained by healthy donors for C. difficile infection. Procedures that are usually performed for the selection of donors for transplantation of feces are as follows. Potential donors stool will be chosen in healthy volunteers that will have given a questionnaire with questions about lifestyle, health status, current therapy, etc., significant clinical symptoms of gastrointestinal disease, etc.. Based on this questionnaire, the potential donor will be considered eligible if excluded: I) Habits of life and risk behaviors, II) Concomitant significant known disorders, III) chronic or recent use of concomitant medications that may interfere with the state of the intestinal microflora (eg, antibiotics), IV) Clinical symptoms indicative of gastrointestinal disease or other diseases of importance, V) Personal or family medical history known of neurodegenerative diseases or other autoimmune diseases.
Moreover, each suitable potential donor will be subjected to the following screening tests: I) Examination of stool for Clostridium difficile bacterial pathogens and protozoa and helminths of the small intestine and colon, Vancomycin-resistant Enterococci (VRE ), Methicillin-resistant Staphylococcus aureus (MRSA), Gram-negative Multidrug-Resistant Organisms (MDR), II) Serological screening for hepatitis virus A,B and C, HIV 1-2, Treponema pallidum, H. pylori, blood count with differential, dose transaminasemia, creatinine and C-reactive protein.
Potential donors negative for this screening will be considered definitively suitable and will be invited to give a stool sample to prepare than for the fecal transplant. The donation will be made in the appropriate circles in the Department of Internal Medicine and Gastroenterology, and the preparation of faeces (manual homogenization in 500 mL of saline solution) for infusion will be performed at the Unit of Analysis 2 ° (Virology and Microbiology).
Analysis of T cell sub-populations will be performed both in peripheral blood and gut mucosa: especially the ratio T Regulatory cells (Tregs)/Th17 cells A Contract Research Organization (CRO) will be in charge for study monitoring.
ALS patients will undergo upper GI endoscopy with small-intestine biopsies (n° 4 biopsies of small intestine, performed with a standard biopsy forces) at baseline and after 6 months. At baseline patients will be randomized (2:1) to either an allogenic (from donors) infusion of collected feces (fecal microbiota transplantation, FMT) (or no procedure in case of allocation to placebo) in the duodenum-jejunum. The infusion will be performed through a standard nasojejunal tube, that will be placed during endoscopy. Infusion of feces will be performed at time 0 and repeated at month 6. The patients allocated to placebo arm will not receive treatment, but will undergo intestinal biopsy.
Upper GI endoscopy 12 months after FMT will be performed only to identify specific microbioma and mucosal immunological evaluation. Fecal samples and small intestine biopsy samples (at baseline, before treatment, and at month 6 and 12) will be obtained from patients to perform the gut microbiota typing.
Every endoscopic procedure will be performed with sedation of the patient. Feces for FMT will be obtained by healthy donors for C. difficile infection. Procedures that are usually performed for the selection of donors for transplantation of feces are as follows. Potential donors stool will be chosen in healthy volunteers that will have given a questionnaire with questions about lifestyle, health status, current therapy, etc., significant clinical symptoms of gastrointestinal disease, etc.. Based on this questionnaire, the potential donor will be considered eligible if excluded: I) Habits of life and risk behaviors, II) Concomitant significant known disorders, III) chronic or recent use of concomitant medications that may interfere with the state of the intestinal microflora (eg, antibiotics), IV) Clinical symptoms indicative of gastrointestinal disease or other diseases of importance, V) Personal or family medical history known of neurodegenerative diseases or other autoimmune diseases.
Moreover, each suitable potential donor will be subjected to the following screening tests: I) Examination of stool for Clostridium difficile bacterial pathogens and protozoa and helminths of the small intestine and colon, Vancomycin-resistant Enterococci (VRE ), Methicillin-resistant Staphylococcus aureus (MRSA), Gram-negative Multidrug-Resistant Organisms (MDR), II) Serological screening for hepatitis virus A,B and C, HIV 1-2, Treponema pallidum, H. pylori, blood count with differential, dose transaminasemia, creatinine and C-reactive protein.
Potential donors negative for this screening will be considered definitively suitable and will be invited to give a stool sample to prepare than for the fecal transplant. The donation will be made in the appropriate circles in the Department of Internal Medicine and Gastroenterology, and the preparation of faeces (manual homogenization in 500 mL of saline solution) for infusion will be performed at the Unit of Analysis 2 ° (Virology and Microbiology).
Analysis of T cell sub-populations will be performed both in peripheral blood and gut mucosa: especially the ratio T Regulatory cells (Tregs)/Th17 cells A Contract Research Organization (CRO) will be in charge for study monitoring.
Conditions
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Amyotrophic Lateral Sclerosis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
randomized double blind multicentre study on FMT in ALS, with a randomization ratio 2:1 (FMT: placebo).
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
placebo will be unrecognizable from active treatment because the patients will undergo endoscopic procedure with sedation
Study Groups
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Fecal microbiota transplantation (FMT)
Fecal microbiota transplantation will be performed during two endoscopic procedures (at baseline and at 6 months) by allogenic infusion of collected feces in the duodenum-jejunum. Fecal microbiota will be diluted in saline solution 200 ml and infused at 30 ml/minute speed. Every endoscopic procedure will be performed with sedation of the patient.
Feces for FMT will be obtained by known healthy donors for C. difficile infection according to standard selection procedures.
Group Type
ACTIVE_COMPARATOR
Fecal microbiota transplantation
Intervention Type
BIOLOGICAL
Fecal microbiota transplantation will be performed during two endoscopic procedures (baseline and at 6 months) by allogenic infusion of collected feces in the duodenum-jejunum.
Placebo
ALS patients will undergo upper GI endoscopy with small-intestine biopsies at baseline and after 6 months. Patients in the placebo arm will not receive any treatment during these procedures, but will undergo intestinal biopsy.
Every endoscopic procedure will be performed with sedation of the patient.
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
BIOLOGICAL
patients will undergo endoscopic procedure with biopsy during sedation but without any kind of intervention
Interventions
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Fecal microbiota transplantation
Fecal microbiota transplantation will be performed during two endoscopic procedures (baseline and at 6 months) by allogenic infusion of collected feces in the duodenum-jejunum.
Intervention Type
BIOLOGICAL
Placebo
patients will undergo endoscopic procedure with biopsy during sedation but without any kind of intervention
Intervention Type
BIOLOGICAL
Other Intervention Names
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FMT
Eligibility Criteria
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Inclusion Criteria
* Patients diagnosed with a laboratory supported, clinically "probable" or "definite" amyotrophic lateral sclerosis according to the Revised El Escorial criteria (Brooks, 2000)
* Sporadic or familial ALS
* Female or male patients aged between 18 and 70 years old
* Disease duration from symptoms onset no longer than 18 months at the screening visit
* Patients treated with a stable dose of Riluzole (100 mg/day) for at least 30 days prior to screening
* Patients with a weight \> 50 kg and a BMI ≥18
* Patients with a FVC (Forced Vital Capacity) equal or more than 70% predicted normal value for gender, height, and age at the screening visit
* Patients able and willing to comply with study procedures as per protocol
* Patients able to understand, and capable of providing informed consent at screening visit prior to any protocol-specific procedures
* Use of effective contraception both for males and females
* Sporadic or familial ALS
* Female or male patients aged between 18 and 70 years old
* Disease duration from symptoms onset no longer than 18 months at the screening visit
* Patients treated with a stable dose of Riluzole (100 mg/day) for at least 30 days prior to screening
* Patients with a weight \> 50 kg and a BMI ≥18
* Patients with a FVC (Forced Vital Capacity) equal or more than 70% predicted normal value for gender, height, and age at the screening visit
* Patients able and willing to comply with study procedures as per protocol
* Patients able to understand, and capable of providing informed consent at screening visit prior to any protocol-specific procedures
* Use of effective contraception both for males and females
Exclusion Criteria
* Known organic gastrointestinal disease
* History of gastrointestinal malignancy; ongoing malignancies
* Use of immunosuppressive or chemotherapy within the past 2 years
* Celiac disease and/or food (e.g.lactose) intolerance
* Previous gastrointestinal surgery
* Any condition that would make endoscopic procedures contraindicated
* Acute infections requiring antibiotics
* Antimicrobial treatment or probiotics 4 weeks prior to screening
* Severe comorbidities (heart, renal, liver failure); severe renal (eGFR\< 30ml/min/1.73m2), or liver failure or liver aminotransferase (ALT/AST \> 2x Upper limit of normal),
* Autoimmune diseases, inflammatory disorders (SLE, Rheumatoid arthritis, connective tissue disorder) or chronic infections (HIV, hepatitis B or C infection)
* Abuse of alcohol or drugs
* HIV, tuberculosis, hepatitis
* Participation in clinical trials \<30 days before screening
* Existing blood dyscrasia (e.g., myelodysplasia)
* White blood cells\<4,000/mm³, platelets count\<100,000/mm³, hematocrit\<30%
* Patients who underwent non-invasive ventilation, tracheotomy and /or gastrostomy
* Women who are pregnant or breastfeeding
* History of gastrointestinal malignancy; ongoing malignancies
* Use of immunosuppressive or chemotherapy within the past 2 years
* Celiac disease and/or food (e.g.lactose) intolerance
* Previous gastrointestinal surgery
* Any condition that would make endoscopic procedures contraindicated
* Acute infections requiring antibiotics
* Antimicrobial treatment or probiotics 4 weeks prior to screening
* Severe comorbidities (heart, renal, liver failure); severe renal (eGFR\< 30ml/min/1.73m2), or liver failure or liver aminotransferase (ALT/AST \> 2x Upper limit of normal),
* Autoimmune diseases, inflammatory disorders (SLE, Rheumatoid arthritis, connective tissue disorder) or chronic infections (HIV, hepatitis B or C infection)
* Abuse of alcohol or drugs
* HIV, tuberculosis, hepatitis
* Participation in clinical trials \<30 days before screening
* Existing blood dyscrasia (e.g., myelodysplasia)
* White blood cells\<4,000/mm³, platelets count\<100,000/mm³, hematocrit\<30%
* Patients who underwent non-invasive ventilation, tracheotomy and /or gastrostomy
* Women who are pregnant or breastfeeding
Minimum Eligible Age
18 Years
Maximum Eligible Age
70 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Modena and Reggio Emilia
OTHER
Sponsor Role
collaborator
Catholic University of the Sacred Heart
OTHER
Sponsor Role
collaborator
Campus Bio-Medico University
OTHER
Sponsor Role
collaborator
Azienda Ospedaliero-Universitaria Careggi
OTHER
Sponsor Role
collaborator
Azienda Ospedaliera di Perugia
OTHER
Sponsor Role
collaborator
University of Chieti
OTHER
Sponsor Role
collaborator
University of Florence
OTHER
Sponsor Role
collaborator
Azienda Ospedaliero-Universitaria di Modena
OTHER
Sponsor Role
lead
Responsible Party
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JESSICA MANDRIOLI
sponsor-investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Clinica Neurologica, Ospedale Clinicizzato "SS Annunziata"
Chieti, , Italy
Site Status
Azienda Ospedaliero Universitaria di Modena
Modena, , Italy
Site Status
UO Neurofisiopatologia, Azienda Ospedaliera dì Perugia
Perugia, , Italy
Site Status
Catholic University of Sacred Heart - Fondazione Policlinico "A. Gemelli"
Roma, , Italy
Site Status
NEuroMuscular Omnicentre Centre (NeMO), Fondazione Serena Onlus-Fondazione Policlinico A. Gemelli
Roma, , Italy
Site Status
Countries
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Italy
References
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ALSUntangled Group. ALS Untangled No. 21: Fecal transplants. Amyotroph Lateral Scler Frontotemporal Degener. 2013 Sep;14(5-6):482-5. doi: 10.3109/21678421.2013.814981. Epub 2013 Jul 22. No abstract available.
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Baxter M, Colville A. Adverse events in faecal microbiota transplant: a review of the literature. J Hosp Infect. 2016 Feb;92(2):117-27. doi: 10.1016/j.jhin.2015.10.024. Epub 2015 Dec 15.
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RESULT
Beers DR, Henkel JS, Zhao W, Wang J, Huang A, Wen S, Liao B, Appel SH. Endogenous regulatory T lymphocytes ameliorate amyotrophic lateral sclerosis in mice and correlate with disease progression in patients with amyotrophic lateral sclerosis. Brain. 2011 May;134(Pt 5):1293-314. doi: 10.1093/brain/awr074.
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Borody TJ, Khoruts A. Fecal microbiota transplantation and emerging applications. Nat Rev Gastroenterol Hepatol. 2011 Dec 20;9(2):88-96. doi: 10.1038/nrgastro.2011.244.
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Bradley WG, Borenstein AR, Nelson LM, Codd GA, Rosen BH, Stommel EW, Cox PA. Is exposure to cyanobacteria an environmental risk factor for amyotrophic lateral sclerosis and other neurodegenerative diseases? Amyotroph Lateral Scler Frontotemporal Degener. 2013 Sep;14(5-6):325-33. doi: 10.3109/21678421.2012.750364. Epub 2013 Jan 4.
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RESULT
Brandt LJ. Fecal Microbiota Transplant: Respice, Adspice, Prospice. J Clin Gastroenterol. 2015 Nov-Dec;49 Suppl 1:S65-8. doi: 10.1097/MCG.0000000000000346.
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RESULT
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Reference Type
RESULT
Henkel JS, Beers DR, Wen S, Rivera AL, Toennis KM, Appel JE, Zhao W, Moore DH, Powell SZ, Appel SH. Regulatory T-lymphocytes mediate amyotrophic lateral sclerosis progression and survival. EMBO Mol Med. 2013 Jan;5(1):64-79. doi: 10.1002/emmm.201201544. Epub 2012 Nov 9.
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RESULT
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Lee YK, Menezes JS, Umesaki Y, Mazmanian SK. Proinflammatory T-cell responses to gut microbiota promote experimental autoimmune encephalomyelitis. Proc Natl Acad Sci U S A. 2011 Mar 15;108 Suppl 1(Suppl 1):4615-22. doi: 10.1073/pnas.1000082107. Epub 2010 Jul 26.
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Longstreth WT Jr, Meschke JS, Davidson SK, Smoot LM, Smoot JC, Koepsell TD. Hypothesis: a motor neuron toxin produced by a clostridial species residing in gut causes ALS. Med Hypotheses. 2005;64(6):1153-6. doi: 10.1016/j.mehy.2004.07.041.
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Sampson TR, Debelius JW, Thron T, Janssen S, Shastri GG, Ilhan ZE, Challis C, Schretter CE, Rocha S, Gradinaru V, Chesselet MF, Keshavarzian A, Shannon KM, Krajmalnik-Brown R, Wittung-Stafshede P, Knight R, Mazmanian SK. Gut Microbiota Regulate Motor Deficits and Neuroinflammation in a Model of Parkinson's Disease. Cell. 2016 Dec 1;167(6):1469-1480.e12. doi: 10.1016/j.cell.2016.11.018.
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van Nood E, Vrieze A, Nieuwdorp M, Fuentes S, Zoetendal EG, de Vos WM, Visser CE, Kuijper EJ, Bartelsman JF, Tijssen JG, Speelman P, Dijkgraaf MG, Keller JJ. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013 Jan 31;368(5):407-15. doi: 10.1056/NEJMoa1205037. Epub 2013 Jan 16.
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Wang S, Xu M, Wang W, Cao X, Piao M, Khan S, Yan F, Cao H, Wang B. Systematic Review: Adverse Events of Fecal Microbiota Transplantation. PLoS One. 2016 Aug 16;11(8):e0161174. doi: 10.1371/journal.pone.0161174. eCollection 2016.
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RESULT
Wu S, Yi J, Zhang YG, Zhou J, Sun J. Leaky intestine and impaired microbiome in an amyotrophic lateral sclerosis mouse model. Physiol Rep. 2015 Apr;3(4):e12356. doi: 10.14814/phy2.12356.
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Zhao W, Xie W, Xiao Q, Beers DR, Appel SH. Protective effects of an anti-inflammatory cytokine, interleukin-4, on motoneuron toxicity induced by activated microglia. J Neurochem. 2006 Nov;99(4):1176-87. doi: 10.1111/j.1471-4159.2006.04172.x. Epub 2006 Oct 2.
Reference Type
RESULT
Other Identifiers
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FeTr-ALS
Identifier Type: -
Identifier Source: org_study_id
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