A Study of Microbiome Transplantation for the Treatment of Constipation and/or Significant Bloating in Patients With Systemic Sclerosis

The University of Texas System (UT)

Status and phase

Enrolling

Phase 2

Conditions

Bloating

Constipation

Treatments

Drug: PRIM-DJ2727

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT06827977

HSC-MS-24-0630

Details and patient eligibility

About

The purpose of this study is to characterize the intestinal flora in subjects with systemic sclerosis-related constipation and/or significant bloating and to determine safety and trends in improvements in the diversity of colonic microbiome and patient symptoms following the administration of either frozen or lyophilized PRIM-DJ2727 microbiota.

Full description

The purpose of this study is to evaluate the tolerability and safety of frozen and lyophilized microbiome transplant product (PRIM- DJ2727), to characterize the microbiome (α-diversity and β-diversity) and metabolome in patients with Systemic Sclerosis (SSc)-related constipation and/or significant bloating, to examine improvement in constipation and/or significant bloating after microbiome transplant, to examine improved colonic transit after microbiome transplant, to examine subjective global improvement and improvement in SSc disease characteristics, to monitor change in concentration of systemic and fecal inflammatory markers, and to monitor for change in fecal short-chain fatty acids and metabolome.

Enrollment

21 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Are seen in the UT Houston Scleroderma Center (UTHSC)
Meet 2013 American college of rheumatology (ACR)/European league against rheumatism (EULAR) criteria or CREST criteria for SSc
Meet Rome IV criteria for constipation and/or significant bloating
Subject willing to sign an informed consent form
Subject deemed likely to survive for ≥ 1 year after enrollment
Able to follow study procedure and follow-up
Sexually active male and female subjects of childbearing potential must agree to use an effective method of birth control during the treatment and follow-up period
Female subjects of childbearing potential must have a negative pregnancy test in the 72 hours before the procedure
Subjects who agree to adhere to a stable diet for at least 4 weeks before joining the study and throughout the study
Subjects must have an attending physician who will provide non-transplant care for the subject

Exclusion criteria

Subjects with constipation and/or significant bloating from causes not attributed to SSc as determined by the treating physician (e.g., inflammatory bowel disease, medication, significant diabetes, or hypothyroidism, etc.)
Subjects unwilling to stop taking probiotic supplements during the duration of the study
Subjects that have post-total or hemicolectomy or the presence of a colostomy
Subjects unable to tolerate microbiome transplant via enema for any reason or swallow capsules
Subjects requiring systemic antibiotic therapy 4 weeks before the study
If subjects are on immunosuppression, the immunosuppression dose should be stable for at least 4 weeks before study enrollment