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

Recruiting
1 - 12 years of age
Both
Phase N/A

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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)

Study details

Functional Constipation

NCT05340712

United Pharmaceuticals

25 January 2024

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