Bond 2018.

Study characteristics
Methods	Design: randomised controlled trial Setting: Australia
Participants	Number of participants: (N = 639) Number of dropouts (per group if available): (N = 19) Inclusion criteria: women ≥ 18 years of age who have delivered a singleton baby at 37 weeks’ gestation or later; not currently taking commercial probiotics containing Lactobacillus fermentum; own a smartphone; with intention at the time of consent to breastfeed their baby for at least 2 months following birth Exclusion criteria: women with a history of Raynaud syndrome will not be eligible to participate in the trial. Any delivery/breast complication rendering the infant unable to breastfeed will be excluded. Women unable to speak/understand English will not be consented.
Interventions	Intervention A: (N = 311) probiotics containing Lactobacillus fermentum CECT5716 (1 × 1010 CFU/mL): 1 sachet daily, preferably at the same time each day for a period of 8 weeks following the birth of her baby. The contents of the sachet should be mixed with water, juice or milk, stirred and consumed immediately. Control B: (N = 309) as per intervention group but sachets do not contain Lactobacillus fermentum Duration of treatment: 8 weeks Duration of follow‐up: 2, 6 and 12 months postpartum
Outcomes	Incidence of mastitis up to 8 weeks following birth as measured by 1) clinical diagnosis of mastitis OR 2) at least 2 of the following breast symptoms: pain,redness/inflammation, lump/swelling AND at least 1 of the following systemic symptoms: flu‐like symptoms (body aches, headaches and chills) or fever ≥ 38°C. Breastfeeding duration (total/partial), recurrence of mastitis, development of breast abscess, cracked nipples, use of antibiotics, overall maternal health and well‐being, breastfeeding support, number of doctor’s visits for probable mastitis, overall doctor’s visits, adverse effects of treatment, incidence of primary mastitis between 2 and 6 months postpartum, maternal lifestyle factors which may affect breastfeeding outcomes, acceptability and compliance of the trial product Secondary infant outcomes: growth (height and weight) and well‐being in the first year of life (measured at 2, 6 and 12 months) as assessed via self‐report of health conditions including infections (gastrointestinal, respiratory), doctor’s visits, admission to hospital, allergic reactions and/or use of antibiotics
Notes	Dates of study: April 2015 to December 2016 Funding sources: "Funding was provided by the The Ramsay Research and Teaching Fund of Royal North Shore Hospital and The Kolling Institute of Medical Research. NN was supported by an Australian NHMRC Career Development Fellowship (#APP1067066). In‐kind support was provided by Intersect Australia Ltd for eResearch support and development of APProve‐Lite. The funders have no role in the design and conduct of the study”. Declarations of interest: “The probiotic and placebo sachets will be donated for the trial by Puremedic Pty Ltd, who will have no direct influence on the conduct, design or implementation of the trial. No trial material will bear the company name or logo. There are no commercial benefits to the researchers as a result of this trial. The authors have no conflicts of interest to report”. Correspondence from lead author diana.bond@sydney.edu.au: no data are available due to restrictions placed on the authors by the probiotics providers (date of last correspondence with trial author: January 2020. Author contacted again July 2020 to ask for any further update; response received from Diana Bond to say unfortunately the situation has not changed and they are still not able to publish the results). Retrospective trial registration
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"The randomisation schedule will be prepared and centrally administered by a researcher not involved in patient care. A computer random number generator will be used to prepare the randomisation schedule in blocks of 4 and 6, and stratified by the incidence of previous mastitis."
Allocation concealment (selection bias)	Low risk	"Participants using the mobile phone application system (APProve‐Lite) will be randomised via a central password‐protected web‐based application developed by the APProve clinical trial unit. Concealment for participants using the ‘standard’ approach (not the APProve‐Lite system) will be via opaque, sealed envelopes."
Blinding of participants and personnel (performance bias) All outcomes	Low risk	"The randomisation sequence will be concealed until all data has been collected. The participant and researcher will be blinded as to treatment allocation."
Blinding of outcome assessment (detection bias) All outcomes	Low risk	The researcher will be blinded as to treatment allocation.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	No results available
Selective reporting (reporting bias)	High risk	Results are unavailable due to restrictions imposed by the probiotics provider.
Other bias	Unclear risk	Insufficient information available