Clinical trial NCT06827977: A Study of Microbiome Transplantation for the Treatment of Constipation in Patients with Systemic Sclerosis
Official title: A Study of Microbiome Transplantation for the Treatment of Constipation in Patients with Systemic Sclerosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Constipation
Keywords: Systemic Sclerosis
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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
* 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 during the study
* Subjects must have an attending physician who will provide non-transplant care for the subject

Exclusion Criteria:

* Subjects with constipation 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 who have diarrhea defined as loose, watery stools three or more times a day
* Subjects that have post-total or hemicolectomy or the presence of a colostomy
* Subjects unable to (a) tolerate microbiome transplant via enema for any reason or (b) 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

Primary outcomes:
measure: Change in symptoms and signs of constipation as assessed by score on the University of California, Los Angeles Gastrointestinal Tract Questionnaire, version 2.0 (UCLA GIT 2.0)
timeFrame: pre-transplant , post-treatment at week 12
measure: Change in symptoms and signs of constipation as assessed by total and subdomain scores on the National Institute of Health Gastrointestinal Patient-Reported Outcomes Measurement Information System (GI PROMIS)
timeFrame: pre-transplant , post-treatment at week 12
measure: Change in symptoms and signs of constipation as assessed by score on the Patient Assessment of Constipation Symptoms (PACSYM)scale
timeFrame: pre-transplant , post-treatment at week 12
measure: Number of participants who show an improvement in constipation symptoms as indicated by the stool diary
timeFrame: from baseline to end of study (week 12)
measure: Change in gut transit times (assessed by Sitz markers and X-ray)
timeFrame: pre-transplant , post-treatment at week 12
Secondary outcomes:
measure: Change in immunoglobulin A (IgA) antibody sequence
timeFrame: pre-transplant , week 12 post-transplant
measure: Change in alpha diversity microbiome
timeFrame: pre-transplant , week 12 post-transplant
measure: Change in beta diversity microbiome between samples
timeFrame: pre-transplant , week 12 post-transplant
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Zsuzsanna McMahan, MD, MHS (M-PI)
role: PRINCIPAL_INVESTIGATOR
References: