Evaluation of the Efficacy of a New Specific Infant Formula in Case of Functional Constipation

Selection Criteria:

Infants presenting with constipation according to modified Rome IV criteria, i.e. they must present with 1 month the following:

• Infants without spontaneous stools or with at least one painful or hard spontaneous bowel movement per week AND

• At least one of the following:

• Two and fewer spontaneous defecations per week

• History of excessive stool retention

• History of large-diameter stools

Non-selection Criteria (non-exhaustive list):

• Preterm birth (<34 weeks of gestational age)

• Exclusively or partially breastfed infants within 3 days prior to visit V-1

• Infants with organic causes of constipation (e.g. coeliac disease, paediatric intestinal pseudo-obstruction, hypothyroidism, spina bifida, anorectal malformation or Hirschsprung's disease) or constipation secondary to endocrine, metabolic, neurologic or autoimmune disorders, surgery or drugs.

• Infants on laxative treatment

• Infants taking drugs that are known to affect gastrointestinal motility as well as any probiotic supplements

• Infants treated with antibiotics

• Infants with a known allergy to one of the formula ingredients (e.g. cow's milk proteins…)

• Infants with anaemia who have been prescribed an oral iron supplement as treatment

• Infants participating in another trial

• Infants presenting with any other situation which, according to the investigator, may interfere with the study participation, or lead to a particular risk for the infant

Inclusion Criteria:

• Infants having completed the selection period and still compliant with non-selection criteria

• Infants being constipated according to modified Rome IV criteria based on information recorded in parents' diary during the week preceding visit V0 (inclusion visit)