Gastrointestinal Working Group

Summary of Current Projects:

• Evaluating the Gastrointestinal Microbiome in SSc: an International Cohort Study
• Validity and Performance of Patient-Reported Outcome Measures for Fecal Incontinence in Systemic Sclerosis (PROM-FISSc)
• Development of a Novel Patient Reported Outcome Measure for Patients with Systemic Sclerosis-Associated Gastrointestinal Disease

Progress to Date:

• International Investigation of the Gut Microbiome (Funded by Boehringer Ingelheim investigator-initiated grant on ILD)
  • New sites recently added (Milan, Florence). Both have executed Material Transfer Agreements and sent the UCLA biorepository their samples (9 international study sites in total)
  • Microbiome sequencing analysis completed for 285 samples from patients across 5 continents using shotgun metagenomics
  • First manuscript accepted for publication in Arthritis Care & Research 2025
  • Fecal metabolite analysis currently underway at UCLA
  • Abstract accepted for presentation at ACR Convergence 2025 exploring the relationship between bacterial species and GI symptoms
• PROM-FISSc project (Funded by SCTC working group grant).
  • Protocol and consent form approved by the UTHealth IRB; review in progress at additional participating sites.
  • Fecal incontinence (FI) survey prepared for patient distribution.
  • Research Electronic Data Capture (REDCap) database under development at UTHealth; to be shared with participating sites upon completion.
• Patient-reported outcome to measure treatment response for SSc-GI Disease (Funding pending)
  • Protocol and consent form approved by UCLA
  • International focus group studies conducted (baseline)
  • Qualitative data analysis has begun

Next Steps:

• Complete analysis and prepare manuscript for the GI microbiome study, integrating data on GI symptoms
• Complete GI metabolite analysis and integrate these data with data on GI symptoms
• Finalize and distribute an anonymous survey to patients with systemic sclerosis to assess their experience with fecal incontinence and identify unmet needs.
• Complete development of the REDCap database for the PROM-FISSc study.
• Initiate patient enrollment for PROM-FISSc.
• Conduct follow-up international focus groups to evaluate how patients describe changes in GI symptoms over time
• Develop item set based on results of focus groups in anticipation of administering survey to international cohort for development of SSc-GI treatment response PROM

Abstracts (accepted for 2025 ACR Convergence):

McMahan ZH, Joshi S, Labus J, Young A, Low AHL, Smith V, Proudman S, Valenzuela A, Hunter P, Andréasson K, Aja E, Jacobs J, Volkmann ER. Association of the gastrointestinal (GI) microbiome and GI symptoms in systemic sclerosis: An international, multi-center, observational study.

Publications:

Andréasson K, Young A, Joshi S, Labus JS, Low AHL, Smith V, McMahan Z, Proudman S, Valenzuela A, Hunter P, Kim GH, Bozovic G, Goldin J, Aja E, Jacobs JP, Volkmann ER. International Investigation of the Gut-Lung Axis in Systemic Sclerosis-Interstitial Lung Disease. Arthritis Care Res (Hoboken). 2025 Aug 4. doi: 10.1002/acr.25623. Epub ahead of print. PMID: 40757465.