Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Goat milk-based infant formula |
|
| Control group | Active Comparator | Cow's milk-based infant formula |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Goat milk-based infant formula | Other | Study product is administered on demand until the age of 6 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal symptoms as determined by CoMiSS | 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). | Difference between groups at Day 14 of the intervention |
| Gastrointestinal tolerance as determined by IGSQ | 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. | Difference between groups at the end of the intervention at 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal symptoms throughout the study as determined by CoMiSS | 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jildou Visser, BSc | Contact | +31885015283 | nutrition.support@ausnutria.nl |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Faissal Specialist Hospital & Research Centre | Riyadh | Saudi Arabia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Randomized, controlled, double-blind clinical trial
Not provided
Not provided
Not provided
| Cow's milk-based infant formula | Other | Study product is administered on demand until the age of 6 months. |
|
| From enrollment to the end of the intervention at 24 weeks |
| Gastrointestinal tolerance throughout the study as determined by IGSQ | 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. | From enrollment to the end of the intervention at 24 weeks |
| Occurrence, duration and severity of gastrointestinal infections as determined by Vesikari | 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. | From enrollment to the end of the intervention at 24 weeks |
| Occurrence, duration and severity of respiratory infections as determined by CARIFS | 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. | From enrollment to the end of the intervention at 24 weeks |
| Occurrence, duration and severity of ear infections as determined by AOM-SOS V5 | 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. | From enrollment to the end of the intervention at 24 weeks |
| Quality of life as determined by PedsQL | 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. | From enrollment to the end of the intervention at 24 weeks |
| Quality of life as determined by WHOQoL-BREF | 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. | From enrollment to the end of the intervention at 24 weeks |
| Weight | Weight will be measured in kilograms. | From enrollment to the end of the intervention at 24 weeks |
| Height | Height will be measured in centimeters. | From enrollment to the end of the intervention at 24 weeks |
| Head circumference | Head circumference will be measured in centimeters. | From enrollment to the end of the intervention at 24 weeks |
| WHO z-scores | 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. | From enrollment to the end of the intervention at 24 weeks |
| Fecal parameters | 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. | Baseline, Day 14, Day 28, Week 12 and Week 24 |
| Sleep and Crying episodes | Sleep and crying episodes and duration are recorded for 24 hours prior to the visits in diaries. | Baseline, Day 14, Day 28, Week 12 and Week 24 |
| Stool frequency & consistenty | Stool frequency and consistency are recorded for 24 hours prior to visits in diaries. | Baseline, Day 14, Day 28, Week 12 and Week 24 |
| ID | Term |
|---|---|
| D007239 | Infections |
Not provided
Not provided
Not provided