Anthropometrics, Gastrointestinal Symptoms, Gastrointestinal Tolerance, Infections, Quality of Life
Conditions
Keywords
Formula, Infant, Goat milk-based infant formula, RCT, Gastrointestinal symptoms, Gastrointestinal tolerance
Brief summary
This randomized controlled double-blind study will compare the effect of a commercially available goat milk formula to a cow's milk formula on gastrointestinal symptoms and tolerance, and infections in infants.
Interventions
Study product is administered on demand until the age of 6 months.
Study product is administered on demand until the age of 6 months.
Sponsors
Ausnutria Hyproca B.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomized, controlled, double-blind clinical trial
Eligibility
Sex/Gender
ALL
Age
14 Days to 90 Days
Healthy volunteers
Yes
Inclusion criteria
* Age between 14 days and 90 days. * Healthy singleton term infants born between 37 weeks and 42 weeks of gestation. * Infants who have received CMF for at least 7 consecutive days. * Exclusive formula feeding. * Cow's Milk-related Symptoms Score (CoMiSS®) value at baseline of ≥6 and \<10. * Parents' or caregivers, aged ≥18 years, willing to give informed consent and adhere to study protocol
Exclusion criteria
* Exclusively or partially feeding with human milk * Introduced to solid food, supplementary feeding, use of pre- and/or probiotics as a supplement * Congenital or recurrent chronic conditions and/or malabsorption that could interfere with study parameters. * Diagnosed cow's milk allergy (CMA) or suspected to have CMA, soy allergy, fish allergy, egg allergy and/or lactose intolerance. * Receiving medication (on own initiative or prescription) with regard to FGID (i.e. reflux medication) * Sibling already participating in this study * Participation in another clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal symptoms as determined by CoMiSS | Difference between groups at Day 14 of the intervention | The CoMiSS® is a simple, fast, and easy-to-use awareness tool for cow's milk-related symptoms and may be used in clinical trials to evaluate and quantify the severity of symptoms during a feeding trial. The CoMiSS scores symptoms in five different domains: Crying, Regurgitation, Stools, Skin and Respiratory. The CoMiSS score ranges from 0 to 33 with score 0 as best score (no symptoms) and 33 as worst score (severe symptoms). |
| Gastrointestinal tolerance as determined by IGSQ | Difference between groups at the end of the intervention at 24 weeks | The IGSQ is a 13-item self-report instrument that has been used in clinical trials to assess infants' GI-related signs and symptoms observed by their parents over the previous week in 5 domains: stooling, regurgitation/vomiting, flatulence, crying, and fussiness. The IGSQ has a possible range of 13 to 65, where higher values indicate greater GI distress and values ≤ 23 indicate no digestive distress. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal tolerance throughout the study as determined by IGSQ | From enrollment to the end of the intervention at 24 weeks | The IGSQ is a 13-item self-report instrument that has been used in clinical trials to assess infants' GI-related signs and symptoms observed by their parents over the previous week in 5 domains: stooling, regurgitation/vomiting, flatulence, crying, and fussiness. The IGSQ has a possible range of 13 to 65, where higher values indicate greater GI distress and values ≤ 23 indicate no digestive distress. |
| Occurrence, duration and severity of gastrointestinal infections as determined by Vesikari | From enrollment to the end of the intervention at 24 weeks | The Vesikari Clinical Severity Scoring System includes a e-diary card completed by parents, to identify rotavirus gastroenteritis episodes. The Vesikari Clinical Severity Scoring System Parameters score ranges from 0 to 20 with score \<7 as mild symptoms and score 10 to 20 as severe symptoms. |
| Occurrence, duration and severity of respiratory infections as determined by CARIFS | From enrollment to the end of the intervention at 24 weeks | Canadian Acute Respiratory Illness and Flu Scale is a validated parental questionnaire, to measure the disease severity of children with acute respiratory illness (ARI) including influenza. CARIFS consists of 18 items covering three domains; symptoms (e.g., cough); function (e.g., play), and parental impact (e.g., clinginess). Each item is scored 0 to 3, with higher scores indicating greater severity of illness. The full scale ranges from 0 to 58. For children older than 5 years the full scale is used; for children younger than 5 years, 3 items (headache, sore throat, and muscle aches) are not used for assessment. |
| Occurrence, duration and severity of ear infections as determined by AOM-SOS V5 | From enrollment to the end of the intervention at 24 weeks | The Acute Otitis Media Symptom Severity scale (AOM-SOS) Version 5.0 is psychometric scale used to measure the severity of symptoms in children with acute otitis media and has been validated for parent-reported use. A 6-point Likert scale ranging from 'No' to 'An extreme amount' is used to rate the presence of 5 symptoms related to acute otitis media over the preceding 24 hours. The AOM-SOS Version 5.0 total score is obtained by summing the scores on these 5 equally-weighted questions. |
| Quality of life as determined by PedsQL | From enrollment to the end of the intervention at 24 weeks | The Pediatric Quality of Life Inventory (PedsQL™) Infant Scales™ is a specific module of the PedsQL™. The objective of this validated questionnaire is to measure generic health-related quality of life in infants. Applicable for infants with acute and chronic health conditions and healthy infants. The questionnaire is composed of 36 items comprising 5 dimensions: physical functioning, physical symptoms, emotional functioning, social functioning and cognitive functioning. Higher scores means better HRQOL and fewer problems or symptoms. A 5-point Likert scale from is applied: 0 (Never) to 4 (Almost always). Scores are transformed on a scale from 0 to 100. |
| Quality of life as determined by WHOQoL-BREF | From enrollment to the end of the intervention at 24 weeks | The World Health Organization Quality of Life Questionnaire BREF (WHOQoL-BREF) is the shortened version of the WHOQoL-100. The WHOQoL-BREF measures quality of life within the context of an individual's culture, value systems, personal goals, standards of concerns. The measuring instrument consists of 26 items. The raw scoreis transformed to a 0-100 scale, where higher scores indicate higher perceived quality of life. |
| Sleep and Crying episodes | Baseline, Day 14, Day 28, Week 12 and Week 24 | Sleep and crying episodes and duration are recorded for 24 hours prior to the visits in diaries. |
| Height | From enrollment to the end of the intervention at 24 weeks | Height will be measured in centimeters. |
| Head circumference | From enrollment to the end of the intervention at 24 weeks | Head circumference will be measured in centimeters. |
| WHO z-scores | From enrollment to the end of the intervention at 24 weeks | Subject's weight, length and head circumference will be used to calculate the WHO z-scores for weight-for-age, length-for-age, head circumference-for-age, weight-for-length. |
| Fecal parameters | Baseline, Day 14, Day 28, Week 12 and Week 24 | The major fecal bacterial groups are defined using 16S RNA sequencing. Further fecal parameters (e.g. pH, SCFA, sIgA, A1AT) are determined with standard laboratory techniques. |
| Stool frequency & consistenty | Baseline, Day 14, Day 28, Week 12 and Week 24 | Stool frequency and consistency are recorded for 24 hours prior to visits in diaries. |
| Weight | From enrollment to the end of the intervention at 24 weeks | Weight will be measured in kilograms. |
| Gastrointestinal symptoms throughout the study as determined by CoMiSS | From enrollment to the end of the intervention at 24 weeks | The CoMiSS® is a simple, fast, and easy-to-use awareness tool for cow's milk-related symptoms and may be used in clinical trials to evaluate and quantify the severity of symptoms during a feeding trial. The CoMiSS scores symptoms in five different domains: Crying, Regurgitation, Stools, Skin and Respiratory. The CoMiSS score ranges from 0 to 33 with score 0 as best score (no symptoms) and 33 as worst score (severe symptoms). |
Countries
Saudi Arabia
Contacts
Primary ContactJildou Visser, BSc
Outcome results
None listed