Gastrointestinal Symptoms and Tolerance in Infants Fed Goat or Cow's Milk-based Infant Formula

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).

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.

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).

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.

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.

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.

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.

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.

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.

Weight will be measured in kilograms.

Height will be measured in centimeters.

Head circumference will be measured in centimeters.

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.

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.

Sleep and crying episodes and duration are recorded for 24 hours prior to the visits in diaries.

Stool frequency and consistency are recorded for 24 hours prior to visits in diaries.