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

Phase 2

Not yet recruiting

• Conditions: Constipation
• Interventions: Drug: Placebo; Drug: PRIM-DJ2727

• Registration Number: NCT06827977
• Lead Sponsor: The University of Texas Health Science Center, Houston

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-09
• Study First Submitted QC: 2025-02-09
• Last Update Submitted: 2025-02-09
• Study First Posted: 2025-02-14
• Last Update Posted: 2025-02-14
• Study Start: 2025-04-02
• Primary Completion: 2025-06-20
• Study Completion: 2025-09-26

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
PRIM-DJ2727	PRIM-DJ2727	-

Primary Outcome Measures

Name	Time	Method
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)	pre-transplant , post-treatment at week 12	This consists of 34 questions covering domains such as diarrhea, constipation, abdominal pain, nausea, bloating, gastroesophageal reflux, fecal incontinence, and emotional well-being related to GI symptoms.Each item is scored on a Likert scale ranging from 0 to 3 (0 = none, 1 = mild, 2 = moderate, 3 = severe), with higher scores indicating greater symptom severity.Domain scores are calculated as the sum of responses to items within the domain, and an optional total score may be calculated by summing all domain scores, representing the overall GI symptom burden. Scores for each domain and the total score range from 0-102
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)	pre-transplant , post-treatment at week 12	The GI PROMIS includes 8 scales, each targeting specific gastrointestinal symptoms. Each item is scored on a scale from 1 to 5, leading to a total raw score range of 9 to 45. These raw scores are then converted to T-scores, which have a mean of 50 and a standard deviation of 10, based on the U.S. general population. A higher T-score indicates a worse outcome, meaning more severe gastrointestinal symptoms.
Change in symptoms and signs of constipation as assessed by score on the Patient Assessment of Constipation Symptoms (PACSYM)scale	pre-transplant , post-treatment at week 12	The PAC-SYM is a 12-item questionnaire assessing abdominal, rectal, and stool symptoms, with each item scored from 0 (No symptoms) to 4 (Very severe symptoms), for a total score range of 0-48. Scores are reported as mean scores per domain and overall, with higher scores indicating worse constipation severity.
Number of participants who show an improvement in constipation symptoms as indicated by the stool diary	from baseline to end of study (week 12)
Change in gut transit times (assessed by Sitz markers and X-ray)	pre-transplant , post-treatment at week 12

Secondary Outcome Measures

Name	Time	Method
Change in immunoglobulin A (IgA) antibody sequence	pre-transplant , week 12 post-transplant
Change in alpha diversity microbiome	pre-transplant , week 12 post-transplant	species richness and evenness within a single sample will be measured
Change in beta diversity microbiome between samples	pre-transplant , week 12 post-transplant

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States