Table 1.

The investigator-initiated RCTs of phage therapy.^*

Name	Phase	Enrollment	Adm route	Target	Indication	Outcome	Developer	Ref.
WPP-201	1	42	Topical	P. aerogenosa, S. aureus, and E. coli	Chronic venous leg ulcers	Safety demonstrated	Southwest Regional Wound Care Center, United States	Rhoads et al. (2009)
Pyophage	2/3	113	IU	Multiple common bacteria	Urinary tract infection	Favorable safety profile, non-inferior to standard-of-care antibiotic treatment.	Balgrist University Hospital, Georgia	Leitner et al. (2021)
NS	1/2	24	Oral	E. coli	Chronic otitis	Safety demonstrated; clinical improvements; and bacteria reduction in the test group only.	Royal National Throat, Nose, and Ear Hospital, United Kingdom	Wright et al. (2009)
Microgen Coli Proteus and T4-like phage cocktail	NA	120	Oral	E. coli	Acute bacterial diarrhea	Safety demonstrated; no substantial intestinal phage replication; the test group showed no amelioration over control group.	Dhaka Hospital of the International, Bangladesh	Sarker et al. (2016)
PP1131	1/2	27	Topical	P. aeruginosa	Burn wound	Safety demonstrated; the control group reduced bacterial burden at faster pace	Burn centers in France and Belgium	Jault et al. (2019)
NS	NA	15	Oral	NS	Healthy	Safety demonstrated	Nestle Research Center, Switzerland	Bruttin and Brüssow (2005)
Microgen Coli Proteus	NA	15	Oral	E. coli and Proteus	Healthy	Safety demonstrated	Bangladesh	McCallin et al. (2013)
Microgen Coli Proteus	1	NS	Oral	E. coli	Healthy	Safety demonstrated	Bangladesh	Sarker et al. (2017)
PreforPro	NA	43	Oral	NS	Mild to moderate gastro-intestinal distress but no diagnosed	Safety demonstrated	Colorado State University, United States	Gindin et al. (2019)

^*NS, Non-specified; NA, Not applicable; Adm. route, Route of administration; Ref., References; IU, Intraurethral/intravesical.