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A Study of Microbiome Transplantation for the Treatment of Constipation in Patients with Systemic Sclerosis

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06827977
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 The University of Texas Health Science Center, Houston
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Zsuzsanna McMahan, MD, MHS (M-PI)
Principal Investigator Affiliation The University of Texas Health Science Center, Houston
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Constipation
Arms & Interventions

Arms

Experimental: PRIM-DJ2727

Placebo Comparator: Placebo

Interventions

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.

Drug: - Placebo

Placebo will also be administered as capsule form week 2-10 and enema at baseline and week 11

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Houston, Texas

Status

Address

The University of Texas Health Science Center at Houston

Houston, Texas, 77030

Site Contact

Zsuzsanna McMahan, MD, MHS (M-PI)

[email protected]

7135007531

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