GUt Microbiome In Early and Established Scleroderma Study


About this study

The purpose of this research is to create a fecal biorepository to study the differences in fecal microbes between patients with systemic sclerosis and patients without systemic sclerosis, as well as to determine the relation between the microbiome in the small intestine and the permeability of the small intestine in patients with systemic sclerosis.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age (years) ≥ 18.
  • Able to provide Written Informed consent.
  • Systemic sclerosis as defined by VEDOSS or ACR/EULAR 2013 Classification criteria.

Exclusion Criteria:

  • Individuals < 18 years.
  • History of IBD (Crohn’s disease or ulcerative colitis), microscopic colitis, or celiac disease.
  • Pregnancy.
  • Prior abdominal surgery (except hernia, fundoplication, C-section, hysterectomy, appendectomy, and cholecystectomy).
  • Prior antibiotic use or new probiotic use in the last 2 weeks.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Ashima Makol, M.B.B.S.

Closed-enrolling by invitation

What is this? (?)
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Margaret Breen-Lyles

(507) 293-0237

More information


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