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. Author manuscript; available in PMC: 2024 Apr 1.
Published in final edited form as: Anaerobe. 2023 Jan 23;80:102699. doi: 10.1016/j.anaerobe.2023.102699

Table 1.

Table summarizing the major changes made to the PROCLAIM study protocol.

Protocol Version Month of IRB Approval Protocol Modifications
Protocols 1 and 2 -- Protocol refinements preceding commencement of study start
Protocol 3.0 August 2018 Quality of life questionnaire, patient diary and phone assessments added. First version of protocol under which study was initiated and screening began in December 2018.
Protocol 4.0 March 2019 1. Removed exclusion criteria for:
  • Oral or parenteral antibacterial therapy
  • Immunodeficiency disorder
2. Timing of Day 13 visit modified.
3. Courier transportation of samples added.
Protocol 5.0 May 2019 1. Inclusion criteria modified:
  • 3 unformed stools changed to no longer need to be 2 consecutive days for 24 hours prior and continuing at time of randomization.
2. Exclusion criteria modified:
  • Abdominal discomfort changed to more than mild.
Protocol 6.0 June 2019 Neutrophil criteria changed from within 90 days of screening to 30.
Protocol 7.0 August 2019 1. Day 13 study visit removed.
2. Inclusion criteria changed:
  • Age lowered to 18.
  • From oral vancomycin to other antibiotics.
3. Exclusion criteria removed:
  • Have had more than 1 episode of C. difficile within 6 months.
  • Myocardial infarction within past 6 months.
  • Have taken any investigational drug in 30 days.
4. Neutrophil count changed from 1000/mm3 to 500/mm3.
Protocol 7.2 February 2020 1. Added possibility of home visits.
2. Diagnostic sample only analyzed when available.
Protocol 7.3 April 2020 New flyers and brochures.
Protocol 8.0 June 2021   2. Removed Inclusion Criteria:
  • ≥3 unformed stools in 24-hour period
  • Oral antibiotic treatment at time of enrollment.
  3. Removed Exclusion Criteria:
  • ≥3 unformed stools 24 hours prior to randomization.
  • Received or plans to use immunotherapy or toxin binding therapy.
  • Diarrhea likely to be caused by another infection or underlying gastrointestinal disorder.
  • Absolute neutrophil count < 500/mm3
  • Need for mechanical ventilation or vasopressors hemodynamic support.
  • Inability to be seen for routine clinical care.
Protocol 8.1 November 2021 1. Study endpoint changed to fecal calprotectin level analysis.
2. Patient number reduced to 50.
3. Study sample at end of study drug treatment incorporated.