Year	Number of participants	Study design and follow‐up	Intervention and duration of therapy	Main outcome	Comments
1963–64	30 769	Prospective placebo‐controlled RCT of Shigella dysentery; follow‐up 109 days24	Phage preparation peroral once a week; therapy 109 days	Incidence of dysentery 3.8 times higher in placebo group Microbiologically confirmed Shigella dysentery 2.6 times higher in placebo group	Effectiveness reported to be greater in infants aged 6–12 months and lowest in children aged 5–7 years Original article in Russian, information drawn from review
1970	8	Case–control study of Vibrio cholerae; no follow‐up26	High dose of phage (1013 PFU), half‐hourly to hourly, until diarrhoea resolved; therapy 5–6 days	Duration and volume diarrhoea reduced in 4/8 patients; tetracycline more effective V. cholerae excretion cleared within 18 hours in responders	Loss of V. cholerae motility reported within 90 minutes of dosing No phage resistance reported after therapy; no statistical analyses reported
2009	39	Prospective double‐blind RCT of chronic venous leg ulcers; no follow‐up27	Phage application via ultrasonic debridement device, followed by wound dressing and bandage; therapy 12 weeks	Safety demonstrated: no significant adverse events Ulcer healing 12 weeks and 24 weeks — no difference (not powered for this)	Bacteriophage‐impregnated dressings included lactoferrin
2009	24	Prospective double‐blind RCT of chronic otitis externa; Pseudomonas aeruginosa; follow‐up 6 weeks28	105 PFU phage application plus meticulous ear cleaning; single application	Significant improvement in symptoms and signs of otitis in phage‐treated group, and in erythema for phage v control at Day 7 (P = 0.02) and Day 21 (P = 0.014); ulceration, granulation and polyps at Day 7 (P = 0.017) and Day 42 (P = 0.025) 3/12 phage‐treated patients demonstrated near‐complete reduction in all visual analogue scores, along with undetectable P. aeruginosa, compared with none in the placebo group	Trial stopped early during interim analysis by primary investigator due to clinical improvement in the phage‐treated group Phage replication in vivo was detected for a mean of 23.1 days (median, 21 days) in the treatment group
2016	120	Prospective double‐blind RCT of acute diarrhoea in children; follow‐up 21 days29	T4 phage cocktail or Microgen ColiProteus phage cocktail; therapy 4 days	No difference in stool load or frequency between groups Safety: no adverse events No significant phage replication in stool (stool output < oral input). No difference in phage titres seen between stool with phage‐sensitive Escherichia coli compared with those without phage‐sensitive E. coli	Trial stopped early at interim analysis due to perceived lack of efficacy Phage interventions targeted E. coli but only 60% of participants had confirmed pathogenic E. coli Diarrhoeal illnesses were probably the result of complex polymicrobial interplay — potential explanation for a lack of efficacy of narrow spectrum phage treatment
2019	27	Prospective double‐blind RCT of clinically infected burn wounds (P. aeruginosa); follow‐up 14 days10	Alginate template soaked in PP1131 at ~ 1 × 106 PFU/mL, applied topically to wounds daily; therapy 7 days	Time to sustained reduction in two‐quadrant bacterial burden was significantly longer in the phage group (median, 144 h [95% CI, 48–NR] v 47 h [95% CI, 23–122]; HR, 0.29 [95% CI, 0.10–0.79]; P = 0.018) Higher proportion of participants had successful treatment outcome in the standard care group than in the phage group (13/17 [76%] v 9/17 [53%]; P = 0.15)	Study population heterogeneity: patients in the phage group were older whereas patients in the standard care group had more severe burns The actual phage dose delivered to patients was substantially lower than anticipated There were phage‐susceptibility differences in phage‐treated patients who had clinical success (89% susceptible) v those that failed (24% susceptible)

HR = hazard ratio; NR = not reached; PFU = plaque‐forming unit; PP1131 = cocktail of 12 natural lytic anti‐P. aeruginosa bacteriophages; RCT = randomised controlled trial.