GI Working Group San Francisco ACR Saturday, November 8

Goals of SCTC GI Working Group Maintain an electronic database that can facilitate collaboration among SSc experts around the World for patients with symptomatic GI involvement. Establish an international working group to validate outcome measures for clinical trials in symptomatic: o Gastroesophageal reflux disease (GERD) o Gastroparesis o Small intestinal bacterial overgrowth (SIBO) o Constipation o Fecal incontinence (FI)

Progress to date Database developed at the University of Michigan using REDCap. Patients who fulfill 2013 revised ACR/EULAR criteria for SSc and have symptoms for at least 3 of the past 7 days of : o (1) GERD, (2) gastroparesis, (3) SIBO, (4) constipation, or (5) fecal incontinence o AND a test confirming that diagnosis in (2) gastroparesis or (3) SIBO o AND a plan to initiate a single intervention (i.e., increase medication dose) are eligible. Baseline questionnaires specific to one scleroderma-associated GI symptom domain (which includes an anchor rating severity) AND the SCTC GIT 2.0 and NIH Promis. After the required interval (four or twelve weeks) of a single intervention, patients again complete the questionnaires specific to their specific SSc-associated GI symptom domain. For each outcome measure, the data will be evaluated for reliability and validity.

Progress to date 17 sites interested; 9 sites IRB approved; 5 sites with enrolled patients.

Follow-Up Data Received to Date

Expected Deliverables and Timelines Expected deliverables: o Continue enrollment in all domains. Timelines: o Manuscript on GERD data within next 12 months. “Authorship order for individuals will be determined by the contribution to the topic being published. This may not be a SCTC member (for example, a gastroenterologist consultant). For all SCTC GI participating centers the lead investigator at that site will be listed as a co-author. If the SCTC GI participating investigators are deemed to have equal contribution with regards to the study design and writing of the manuscript then authorship order will be determined by the number of patients recruited into the SCTC GI project.”

How can sites get involved? Contact: o Study coordinators: Jennifer Serrano Harley Ross o Phone: o Address: 300 North Ingalls St. Suite 7D12 Ann Arbor, MI o Investigators: Dinesh Khanna Tracy M. Frech Zsuzsanna H. McMahan

Next Steps Increase site participation. Manuscripts in each domain. Ad hoc analyses for bloating and distention. IRB amendment to allow consenting over phone. Exploratory analyses of intervention in GERD sub-cohort. Serial manometry assessment.