Overview
This study aims to assess the clinical efficacy, safety and tolerance of a new formula containing a prebiotic and a mix of probiotics in the specific population of infants suffering from functional constipation through a superiority, double-blind, randomized, placebo-controlled trial.
Description
The study comprises a selection period of 1 week where the eligibility of the infant to participate in the study will be evaluated. Once his/her participation is confirmed, the tested formula will be compared to a standard formula during a 2-month study period followed by an optional follow-up period of 2 months where only the tested formula will be used.
Eligibility
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)