TABLE 1.

Tools to facilitate design, reporting, managing risk of bias, and critical appraisal of human intervention studies with probiotics.

Tool name	References and links
Clinical trial protocol design guidelines
International council for harmonization of technical requirements for pharmaceuticals for human use E6 (R2)	https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf
Statistical principles for clinical trials E9	https://database.ich.org/sites/default/files/E9_Guideline.pdf
Structure and content of clinical study reports E3	https://database.ich.org/sites/default/files/E3_Guideline.pdf
SPIRIT 2013	https://www.spirit-statement.org/
	https://www.spirit-statement.org/publications-downloads/
Critical appraisal tools (quality assessment)
JBI checklists (Joanna Briggs Institute, 2017)	(Tufanaru et al., 2017) https://joannabriggs.org/ebp/critical_appraisal_tools, https://joannabriggs.org/sites/default/files/2019-05/JBI_RCTs_Appraisal_tool2017_0.pdf
CASP checklists (Critical appraisal skills program, 2018)	https://casp-uk.net/wp-content/uploads/2018/01/CASP-Randomised-Controlled-Trial-Checklist-2018.pdf
Critical appraisal checklists (SURE, 2018)	https://www.cardiff.ac.uk/__data/assets/pdf_file/0005/1142969/SURE-CA-form-for-RCTs-and-other-experimental-studies_2018.pdf
BMJ Best practice toolkit (BMJ publishing group limited, 2019)	https://bestpractice.bmj.com/info/us/toolkit/learn-ebm/appraising-2-armed-randomized-controlled-trials/
SIGN checklists and notes (Scottish Intercollegiate Guidelines Network, 2001-2019)	(Harbour and Miller, 2001) https://www.sign.ac.uk/assets/checklist_for_controlled_trials.doc
Critical appraisal tools (Centre for Evidence-Based Medicine, 2020)	https://www.cebm.net/wp-content/uploads/2018/11/RCT.pdf
EQUATOR (Enhancing the quality and transparency of health research) Network	https://www.equator-network.org
Risk of Bias assessment tool
RoB 2 tool	(Sterne et al., 2019) https://methods.cochrane.org/bias/resources/rob-2-revised-cochrane-risk-bias-tool-randomized-trials, https://sites.google.com/site/riskofbiastool/welcome/rob-2-0-tool
Reporting guidelines
CONSORT 2010	(Schulz et al., 2010) http://www.consort-statement.org/consort-2010