Fecal Microbial Transplant (FMT) for Sjogrens Syndrome

NCT03926286 | Completed Phase 1 FDA Drug

• 1 other identifier: 20170733
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label study to evaluate the effect of Fecal Microbiota Transplantation (FMT) on the gut microbiome and Systemic parameters.

Conditions

Sjogren's Syndrome

Keywords

Dry Eye; Auto-Immune Disorder

Outcome Measures

Primary Outcomes (2)

• Number of participants with reported adverse events (AEs) and serious adverse events (SAEs)

  As an evaluation of the safety of FMT, the number of participants with reported AEs and SAEs will be collected. All occurrences of AEs and SAEs, regardless of relatedness to FMT, will be reported and assessed by the clinician using the NIH CTCAE.

  7 months

• Number of participants with stable microbiome engraftment

  Engraftment will be analyzed via the Jensen-Shannon divergence (JSD). The engraftment scores will be the ratio between the donors and recipients at the bacterial genus level. Participants who successfully engraft will more closely resemble the donor microbial profile on JSD analysis.

  month 3

Secondary Outcomes (11)

• Change in dry eye symptoms

  baseline, 1 week, 1 month, 3 months

• Change in dry eye symptoms

  baseline, 1 week, 1 month, 3 months

• Change in diversity of bacterial communities

  Pre FMT, 3 months post FMT

• Change in system immune profiles as measured by T cell populations

  Pre-FMT, 1 Week, 1 Month, 3 months post FMT

• Change in ocular and systemic symptoms as measured by the quality of life SF-12 Questionnaire

  Pre-FMT, 1 Week, 1 Month, 3 months post FMT

Study Arms (1)

FMT for Sjogrens

EXPERIMENTAL

FMT- active ingredient coming from participant's screening stool

Drug: FMP-30

Interventions

FMP-30 DRUG

FMP-30 containing frozen human fecal microbiota administered as (3) units of FMP30 enema on Day 0 and Week1

FMT for Sjogrens

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Positive diagnosis of Sjogrens syndrome, defined by meeting two or more of the following three criteria:
• Positive serum anti-SS-A/Ro and/or anti-SS-B/La (or positive rheumatoid factor and ANA ≥ 1:320)
• Labial salivary gland biopsy exhibiting focal lymphocytic sialadenitis with a focus score ≥ focus/4 mm2
• Keratoconjunctivitis sicca with ocular staining score ≥ 3 (assuming that individual is not currently using daily eye drops for glaucoma, and has not had corneal surgery or cosmetic eyelid surgery in the last 5 years)
• Or by both of the following:
• Positive antibodies to one of the early markers of Sjogrens Syndrome:
• Anti-salivary gland protein 1 (SP1)
• Anti-carbonic anhydrase 6 (CA6)
• Parotid secretory protein (PSP) Ocular staining score ≥ 3
• Age ≥ 18 years at time of enrollment
• Able to provide signed and dated informed consent
• Women of child childbearing potential in sexual relationships with men must use an acceptable method of contraception§ from 30 days prior to enrollment until 4 weeks after completing study treatment.
• Males must agree to avoid impregnation of women during and for four weeks after completing study treatment through use of an acceptable method of contraception\*.
• Includes, but is not limited to, barrier with additional spermicidal foam or jelly, intrauterine device, hormonal contraception (started at least 30 days prior to study enrollment), intercourse with men who underwent vasectomy.
• Includes, but is not limited to, barrier with additional spermicidal foam or jelly and vasectomy.

You may not qualify if:

• Inability to provide informed consent and/or unable or unwilling to comply with protocol requirements.
• Antibiotics for at least 2 weeks prior to FMT.
• Active infection for \>15 days: bacteremia, urinary tract infection, pneumonia or abdominal collection.
• Known or suspected toxic megacolon and/or known small bowel ileus.
• Previous FMT
• Major gastrointestinal surgery (e.g. significant bowel resection) within 3 months before enrollment. This does not include appendectomy or cholecystectomy.
• History of total colectomy or bariatric surgery.
• Antibiotics for the treatment of an active infection or anticipated antibiotic use during trial duration.
• Concurrent intensive induction chemotherapy, radiation therapy or biological treatment for active malignancy.
• Expected life expectancy \< 6 months
• Patients with a history of severe anaphylactic or anaphylactoid food allergy.
• Solid organ transplant patients ≤ 90 days post-transplant or on active treatment for rejection.
• Neutropenia (\<500 neutrophils/mL) or other severe immunosuppression. Patients on monoclonal antibodies to B and T cells, anti-tumor necrosis factor, glucocorticoids, antimetabolites, calcineurin inhibitors may be enrolled after consultation with their medical doctor.
• Renal failure (GFR \<30 or dialysis)
• Human immunodeficiency virus+ controlled or not well controlled on antiretroviral therapy

Sponsors & Collaborators

• University of Miami: lead
• Sjogrens Syndrome Foundation: collaborator
• Microbiome Health Research Institute: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33133, United States

Location

Related Publications (4)

• Zaheer M, Wang C, Bian F, Yu Z, Hernandez H, de Souza RG, Simmons KT, Schady D, Swennes AG, Pflugfelder SC, Britton RA, de Paiva CS. Protective role of commensal bacteria in Sjogren Syndrome. J Autoimmun. 2018 Sep;93:45-56. doi: 10.1016/j.jaut.2018.06.004. Epub 2018 Jun 20.

  PMID: 29934134 BACKGROUND

• De Luca F, Shoenfeld Y. The microbiome in autoimmune diseases. Clin Exp Immunol. 2019 Jan;195(1):74-85. doi: 10.1111/cei.13158.

  PMID: 29920643 BACKGROUND

• Wang C, Zaheer M, Bian F, Quach D, Swennes AG, Britton RA, Pflugfelder SC, de Paiva CS. Sjogren-Like Lacrimal Keratoconjunctivitis in Germ-Free Mice. Int J Mol Sci. 2018 Feb 13;19(2):565. doi: 10.3390/ijms19020565.

  PMID: 29438346 BACKGROUND

• de Paiva CS, Jones DB, Stern ME, Bian F, Moore QL, Corbiere S, Streckfus CF, Hutchinson DS, Ajami NJ, Petrosino JF, Pflugfelder SC. Altered Mucosal Microbiome Diversity and Disease Severity in Sjogren Syndrome. Sci Rep. 2016 Apr 18;6:23561. doi: 10.1038/srep23561.

  PMID: 27087247 BACKGROUND

MeSH Terms

Conditions

Sjogren's Syndrome; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Anat Galor, MD, MSPH

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 24, 2019
• Study Start: April 15, 2019
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: June 5, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)