Microbiome Transplantation for Constipation

Recruiting in Palo Alto (17 mi)

Overseen ByZsuzsanna McMahan, MD, MHS (M-PI)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: The University of Texas Health Science Center, Houston

Prior Safety Data

Trial Summary

What is the purpose of this trial?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, to examine improvement in constipation after microbiome transplant by comparing post-treatment with pre- treatment fecal samples and patient-reported outcome measures, to examine improved colonic transit after microbiome transplant , to examine subjective global improvement and improvement in SSc disease characteristics, to monitor change for change in concentration in systemic and fecal inflammatory markers to monitor for change in fecal short-chain fatty acids and metabolome and to provide data that will be used to determine the appropriateness of designing a properly powered clinical trial of microbial restoration treatment in the SSc population

Eligibility Criteria

This trial is for individuals with Systemic Sclerosis who are experiencing constipation. Participants should have a confirmed diagnosis and be struggling with bowel movements despite trying other treatments.

Inclusion Criteria

I meet the specific criteria for constipation.

Patients seen in the UT Houston Scleroderma Center (UTHSC)

Patients who meet 2013 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria or CREST criteria for SSc

+7 more

Exclusion Criteria

My constipation is not caused by systemic sclerosis.

Subjects unwilling to stop taking probiotic supplements during the duration of the study

Subjects unable to (a) tolerate microbiome transplant via enema for any reason or (b) swallow capsules

+4 more

Participant Groups

The study tests PRIM-DJ2727, a microbiome transplant product, against a placebo to see if it can improve constipation in Systemic Sclerosis patients by altering gut bacteria and metabolites.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: PRIM-DJ2727Experimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention