Evaluation of the Efficacy of a New Specific Infant Formula in Case of Functional Constipation
- Conditions
- Functional Constipation
- Interventions
- Dietary Supplement: Standard formulaDietary Supplement: new infant formula
- Registration Number
- NCT05340712
- Lead Sponsor
- United Pharmaceuticals
- 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.
- 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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)
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard formula Standard formula The control product is a standard infant formula based on cow's milk proteins containing usual lactose and magnesium content, no prebiotic nor probiotic. IT formula new infant formula 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.
- Primary Outcome Measures
Name Time Method Hard stool consistency or painful defecation 30 days 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.
- Secondary Outcome Measures
Name Time Method Painful defecation 30, 60, 90 and 120 days Painful defecation will be evaluated by parents for each stool during the week preceding each visit (Yes/No).
Excessive stool retention 30, 60, 90 and 120 days "Excessive stool retention" is defined as "the infant withholding stools". It will be evaluated by parents at each visit (presence/absence).
Treatment success 30, 60, 90 and 120 days Treatment success is defined as no longer meeting the modified Rome IV criteria for functional constipation, i.e. the treatment will be considered as a success if the infant does not meet more than one of the following criteria per week during the week preceding each visit:
1. At least one painful or hard spontaneous bowel movement (Yes/No)
2. Two or fewer spontaneous defecations per week (Yes/No)
3. Excessive stool retention (Yes/No)
4. Large-diameter stools (assessed using the BITSS as described in the outcome 6) (Yes/No)Weight 30, 60, 90 and 120 days Weight will be expressed in kg and in z scores according to the World Health Organization (WHO) Child Growth Standards.
BMI 30, 60, 90 and 120 days BMI will be expressed in value and z scores according to the WHO Child Growth Standards.
Rescue medication use 30, 60, 90 and 120 days The frequency of use, type and dosage of rescue medication will be assessed by parents during the whole study.
Stool consistency 30, 60, 90 and 120 days Parents will record the consistency of every stool the week preceding each visit as described in the outcome 1 using the BITSS scale (Brussels Infant and Toddler Stool Scale) which consists of 4 stools consistency categories (hard, formed, loose, or watery ; Huysentruyt et al., 2019)
Large diameter stools 30, 60, 90 and 120 days Large diameter stools will be assessed by parents at each visit using the picture of the largest stool in the BITSS as an example of the large diameter stool (presence/absence).
Height 30, 60, 90 and 120 days Height will be expressed in cm and in z scores according to the WHO Child Growth Standards.
Sleep time satisfaction 30, 60, 90 and 120 days Sleep time satisfaction will be evaluated by parents at each visit (Yes/No).
Gut microbiota composition 0 and 60 days Gut microbiota composition will be analyzed by 16S rRNA gene sequencing from stool samples.
Short-chain fatty acids (SCFAs) 0 and 60 days SCFAs will be measured in stool samples by gas chromatography/mass spectrometry (GC/MS).
Total and spontaneous defecation frequency 30, 60, 90 and 120 days Spontaneous bowel movement is defined as a bowel movement not produced by the use of rescue medication. Stools occurring within 24h after the use of rescue medication will not be considered spontaneous. If 2 stools occur within less than 1 hour, only 1 stool will be considered (Koppen et al., 2018).
Defecation frequency will be assessed by parents by recording the time of each stool during the week preceding each visit.Head circumference 30, 60, 90 and 120 days Head circumference will be expressed in cm and in z scores according to the WHO Child Growth Standards.
Nutritional status 0 and 60 days Nutritional status will be assessed based on the evaluation of specific blood biological markers (albumin, creatinine, urea, hemoglobin, sodium, potassium, chloride).
Crying time 30, 60, 90 and 120 days Daily crying duration will be assessed by parents on 3 days in the week preceding each visit.
Parents' quality of life (QoL) 30, 60, 90 and 120 days Parents' QoL will be assessed based on a questionnaire adapted from the Parental Opinions of Pediatric Constipation (POOPC) scale (Silverman et al., 2015). Questions from this scale were chosen based on their relevance to constipated infants. This questionnaire is composed of 4 items, i.e. Burden/Worry, Family, Treatment and Social. Each question is scored on a scale of 1 (=Strongly Disagree) to 5 (=Strongly Agree) with higher scores indicating that infant's constipation greatly affects parents' QoL. The total score is calculated by summing the scores of all individual question, ranging from 15 to 75 where a score of 15 indicates that infant's constipation does not affect parents' QoL whereas a score of 75 indicates that parents' QoL is extremely affected by infant's constipation.
Adverse events Through study completion, i.e. 67 days or 127 days if participation to the optional follow-up period Any untoward medical condition occurring during the study in an infant receiving study products regardless of a causal relationship with the product or not will be considered an adverse event and reported as such. This definition includes events occurring from the moment the parents have signed the Informed Consent form (day -7) up until the study end (or early termination).
Regurgitations 30, 60, 90 and 120 days The number of regurgitation episodes, the volume of regurgitation and regurgitation severity will be assessed by parents on 3 days in the week preceding each visit. Regurgitation severity will be assessed through the Vandenplas score ranging from 0 (=less than 2 regurgitation episodes / day) to 6 (=regurgitation of the complete volume after each feeding).
Sleep quality 30, 60, 90 and 120 days Sleep quality will be evaluated by parents at each visit by asking them if their child's sleep was quiet or agitated.
Parents' satisfaction 30, 60, 90 and 120 days Parents' adequate relief will be assessed at each visit (Yes/No).
Trial Locations
- Locations (2)
University of Naples "Federico II"
🇮🇹Napoli, Italy
University of Campania Luigi Vanvitelli
🇮🇹Napoli, Italy