RECRUITING

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

Conditions

Constipation Bloating Systemic Sclerosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-03-03

Study Completion:2026-09-26

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06827977

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Zsuzsanna McMahan, MD, MHS

CONTACT

713-500-7531

Zsuzsanna.H.McMahan@uth.tmc.edu

Ashish P Balar, MBBS, MPH

CONTACT

713-500-4409

Ashish.P.Balar@uth.tmc.edu

Principal Investigator

Zsuzsanna McMahan, MD, MHS

PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Study Locations (Sites)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center, Houston

Zsuzsanna McMahan, MD, MHS, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center, Houston

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-03

Study Completion Date2026-09-26

Study Record Updates

Study Start Date2025-03-03

Study Completion Date2026-09-26

Terms related to this study

Keywords Provided by Researchers

Systemic Sclerosis

Additional Relevant MeSH Terms

Constipation
Bloating