Status:
UNKNOWN
Evaluation of the Efficacy of a New Specific Infant Formula in Case of Functional Constipation
Lead Sponsor:
United Pharmaceuticals
Collaborating Sponsors:
Delta Consultants
Conditions:
Functional Constipation
Eligibility:
All Genders
1-12 years
Phase:
NA
Brief Summary
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 co...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
July 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05340712
Start Date
July 20 2022
End Date
September 1 2024
Last Update
November 7 2022
Active Locations (2)
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1
University of Naples "Federico II"
Napoli, Italy, 80131
2
University of Campania Luigi Vanvitelli
Napoli, Italy, 80138