Microbiome Transplantation for Constipation

Overseen By Precious Onwuzuligbo

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: The University of Texas Health Science Center, Houston

Must not be taking: Probiotics, Antibiotics

Disqualifiers: Diarrhea, Colostomy, Diabetes, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

21 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must stop taking probiotic supplements during the study. If you are on immunosuppressive medication, the dose should be stable for at least 4 weeks before joining the trial.

What data supports the effectiveness of the treatment PRIM-DJ2727 for constipation?

Research shows that fecal microbiota transplantation (FMT), which involves transferring healthy bacteria to the gut, can help improve symptoms in people with constipation. Studies have found that FMT, sometimes combined with dietary fiber and probiotics, can be effective for different types of constipation. ^{1 2 3 4 5}

Is fecal microbiota transplantation (FMT) safe for treating constipation?

Research on fecal microbiota transplantation (FMT) for constipation suggests it is generally safe, as studies have evaluated its safety alongside its effectiveness for different types of constipation. ^{1 2 3 4 5}

How is the treatment PRIM-DJ2727 for constipation different from other treatments?

PRIM-DJ2727 is unique because it involves microbiome transplantation, which means transferring healthy bacteria from a donor's gut to the patient's gut to improve bowel function, unlike traditional constipation treatments that often rely on medications or dietary changes. ^{1 2 3 4 5}

Research Team

Zsuzsanna McMahan, MD, MHS (M-PI)

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

This trial is for individuals with Systemic Sclerosis who are experiencing constipation. Participants should have a confirmed diagnosis and be struggling with bowel movements despite trying other treatments.

Inclusion Criteria

I meet the specific criteria for constipation.

Patients seen in the UT Houston Scleroderma Center (UTHSC)

Patients who meet 2013 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria or CREST criteria for SSc

Exclusion Criteria

My constipation is not caused by systemic sclerosis.

Subjects unwilling to stop taking probiotic supplements during the duration of the study

Subjects unable to (a) tolerate microbiome transplant via enema for any reason or (b) swallow capsules

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive microbiome transplantation treatment with PRIM-DJ2727 or placebo

12 weeks

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• PRIM-DJ2727

Trial Overview The study tests PRIM-DJ2727, a microbiome transplant product, against a placebo to see if it can improve constipation in Systemic Sclerosis patients by altering gut bacteria and metabolites.

Participant Groups

Group I: PRIM-DJ2727 Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Characteristics of fecal microbiota in different constipation subtypes and association with colon physiology, lifestyle factors, and psychological status. [2023]

2. China pubmed.ncbi.nlm.nih.gov

[Efficacy observation of periodic fecal microbiota transplantation in the treatment of refractory constipation]. [2018]

3. China pubmed.ncbi.nlm.nih.gov

[Short-term efficacy on fecal microbiota transplantation combined with soluble dietary fiber and probiotics in the treatment of slow transit constipation]. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Potential role of fecal microbiota in patients with constipation. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Relationship Between Microbiota of the Colonic Mucosa vs Feces and Symptoms, Colonic Transit, and Methane Production in Female Patients With Chronic Constipation. [2022]