Evaluation of the Efficacy of a New Specific Infant Formula in Case of Functional Constipation
1 other identifier
interventional
80
1 country
2
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 constipation through a superiority, double-blind, randomized, placebo-controlled trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2022
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2022
CompletedFirst Posted
Study publicly available on registry
April 22, 2022
CompletedStudy Start
First participant enrolled
July 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2024
CompletedNovember 7, 2022
November 1, 2022
1.4 years
April 8, 2022
November 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hard stool consistency or painful defecation
Proportion of hard or painful stools per total number of spontaneous bowel movements by participant. A spontaneous bowel movement is defined as described in outcome 2. Stool consistency will be evaluated based on the Brussels Infant and Toddler Stool Scale (BITSS). BITSS is a reliable instrument to assess stools of non-toilet trained children. It consists of color photographs of nappies containing stools from infants and toddlers categorized as hard, formed, loose, or watery (Huysentruyt et al., 2019). The consistency and painful defecation of each stool will be assessed by parents at Day 30.
30 days
Secondary Outcomes (21)
Total and spontaneous defecation frequency
30, 60, 90 and 120 days
Stool consistency
30, 60, 90 and 120 days
Painful defecation
30, 60, 90 and 120 days
Excessive stool retention
30, 60, 90 and 120 days
Large diameter stools
30, 60, 90 and 120 days
- +16 more secondary outcomes
Study Arms (2)
IT formula
EXPERIMENTALThe 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.
Standard formula
PLACEBO COMPARATORThe control product is a standard infant formula based on cow's milk proteins containing usual lactose and magnesium content, no prebiotic nor probiotic.
Interventions
New formula containing a prebiotic and a mix of probiotics, randomly assigned to infants during a 2-month period and allocated to all infants during the optional open-label follow-up period of 2 months.
Standard infant formula containing no prebiotic nor probiotic, randomly assigned to infants during a 2-month period followed by an optional open-label follow-up period of 2 months with the new infant formula
Eligibility Criteria
You may qualify if:
- Infants having completed the selection period and still compliant with non-selection criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- United Pharmaceuticalslead
- Delta Consultantscollaborator
Study Sites (2)
University of Naples "Federico II"
Napoli, 80131, Italy
University of Campania Luigi Vanvitelli
Napoli, 80138, Italy
Related Publications (3)
Huysentruyt K, Koppen I, Benninga M, Cattaert T, Cheng J, De Geyter C, Faure C, Gottrand F, Hegar B, Hojsak I, Miqdady M, Osatakul S, Ribes-Koninckx C, Salvatore S, Saps M, Shamir R, Staiano A, Szajewska H, Vieira M, Vandenplas Y; BITSS working group. The Brussels Infant and Toddler Stool Scale: A Study on Interobserver Reliability. J Pediatr Gastroenterol Nutr. 2019 Feb;68(2):207-213. doi: 10.1097/MPG.0000000000002153.
PMID: 30672767BACKGROUNDKoppen IJN, Saps M, Lavigne JV, Nurko S, Taminiau JAJM, Di Lorenzo C, Benninga MA. Recommendations for pharmacological clinical trials in children with functional constipation: The Rome foundation pediatric subcommittee on clinical trials. Neurogastroenterol Motil. 2018 Apr;30(4):e13294. doi: 10.1111/nmo.13294. Epub 2018 Jan 30.
PMID: 29380480BACKGROUNDSilverman AH, Berlin KS, Di Lorenzo C, Nurko S, Kamody RC, Ponnambalam A, Mugie S, Gorges C, Sanghavi R, Sood MR. Measuring Health-Related Quality of Life With the Parental Opinions of Pediatric Constipation Questionnaire. J Pediatr Psychol. 2015 Sep;40(8):814-24. doi: 10.1093/jpepsy/jsv028. Epub 2015 Apr 2.
PMID: 25840448BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Annamaria Staiano, Prof.
Federico II University
- STUDY CHAIR
Marc Benninga, Prof.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- PRINCIPAL INVESTIGATOR
Caterina Strisciuglio, Prof.
University of Campania Luigi Vanvitelli
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The allocation of the formula to each infant is drawn according to a randomization list developed using a software by the clinical research organization in charge of statistics and known only to him until the blind is lifted, i.e. after the statistical analysis. A 1:1 double-blind randomisation will be computer-generated by block (in each center).
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2022
First Posted
April 22, 2022
Study Start
July 20, 2022
Primary Completion
December 1, 2023
Study Completion
September 1, 2024
Last Updated
November 7, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share