Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
NCT ID:
NCT05340712
Eligibility 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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Month
Maximum Age:
12 Months
Study:
NCT05340712
Study Brief:
Protocol Section:
NCT05340712