Table 1.

Study sessions and procedure.

Procedures			Intervention period													Observation period
			V1a		H1b		H2		V2		H3		V3		H4			V4		H5		V5
Informed consent			✓
Inclusion and exclusion criteria			✓
Physical examination			✓																			✓
Medical history			✓
Demographics			✓
Anthropometry			✓						✓				✓					✓				✓
Randomization			✓
Fecal samples					✓		✓				✓				✓					✓
Questionnaires
	IGSQ-13c	✓						✓				✓
	PISId							✓				✓					✓				✓
	BISQe	✓						✓				✓
	ITQoL-SFf 47							✓				✓
Diaries
	Stooling	✓				✓				✓
	3-day food									✓				✓					✓
	Breastfeeding (BGg only)	✓						✓				✓					✓				✓
	Formula milk intake	✓						✓				✓					✓				✓
	Infant illness	✓		✓		✓		✓		✓		✓		✓			✓		✓		✓
Investigational product
	Administer trial formula (EGh/CGi only)			✓		✓		✓		✓		✓
	Adverse event collection	✓		✓		✓		✓		✓		✓		✓			✓		✓		✓

^aV: visit.

^bH: home.

^cIGSQ: Infant Gastrointestinal Symptom Questionnaire.

^dPISI: Pediatric Immune System Index.

^eBISQ: Brief Infant Sleep Questionnaire.

^fITQoL-SF: Infant Toddler Quality of Life Questionnaire-Short Form.

^gBG: breastfed group.

^hEG: experimental group.

ⁱCG: control group.