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

United Pharmaceuticals

Status: Enrolling

Conditions: Functional Constipation

Treatments: Dietary Supplement: Standard formula; Dietary Supplement: new infant formula

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05340712

UP2021-02-FALCON

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 1 to 12 months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

80 participants in 2 patient groups, including a placebo group

IT formula

Experimental group

Description:

The test product (IT formula) is an infant formula based on cow's milk proteins containing a high level of lactose, a prebiotic, a high concentration of magnesium and a mix of probiotics.

Treatment:

Dietary Supplement: new infant formula

Standard formula

Placebo Comparator group

Description:

The control product is a standard infant formula based on cow's milk proteins containing usual lactose and magnesium content, no prebiotic nor probiotic.

Treatment:

Dietary Supplement: Standard formula