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

Launched by THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER, HOUSTON · Feb 9, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment for constipation in patients with a condition called systemic sclerosis (SSc). The researchers want to see if a special product made from healthy bacteria (called a microbiome transplant) can help improve constipation symptoms. They will look at how safe and well-tolerated the treatment is, as well as how it affects the gut health and overall well-being of the participants. By comparing fecal samples and patient feedback before and after the treatment, the study aims to gather important information to help design future trials.

To be eligible for this study, participants should be receiving care at the UT Houston Scleroderma Center and meet specific criteria for SSc and constipation. They need to be willing to follow certain guidelines, like maintaining a stable diet and using birth control if they are of childbearing age. However, individuals with constipation caused by other conditions or those who take certain medications may not be able to join. Participants will receive the microbiome transplant and will be monitored for any changes in their symptoms and overall health throughout the study.

Gender

ALL

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 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