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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
PRIM-DJ2727
  • Drug: PRIM-DJ2727
    For oral administration, each dose will contain the number of capsules needed to deliver the lyophilized intestinal bacteria powder derived after lyophilization of 60 g of filtered stool in 300 mL 0.85% NaCl and 2% mannitol. Participants will take the capsules (5-6 capsules twice weekly) from week 2 through week 10. Capsules will be taken over a period of up to one hour to maximize tolerance and ensure the capsules are not expelled by vomiting. For administration via retention enema, which will be done at baseline and week 11, 50 g of filtered, frozen stool in 250 mL of 0.85% sodium chloride (NaCl) will be used.
Placebo Comparator
Placebo
  • Drug: Placebo
    Placebo will be administered as capsules from week 2-10 and as enema at baseline and week 11.

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Zsuzsanna McMahan, MD, MHS
713-500-7531
Zsuzsanna.H.McMahan@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Zsuzsanna McMahan, MD, MHS
713-500-7531
Zsuzsanna.H.McMahan@uth.tmc.edu

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.