Comfort Next study

INTERVENTION: The screening of children for the identification and recruitment of eligible ones will be conducted during the visit to a paediatrician related to experiencing hard stools and constipation. Toddlers who are diagnosed with constipation according to Rome III criteria will undergo a medicinal treatment as prescribed by their physician/paediatrician for constipation. The study will start after the treatment of the acute problem has been finished, constipation resolved and laxative decreased to the maintenance levels. The laxatives in decreasing dose will be provided during the first month of the study. During the second month there will be no laxatives provided, unless necessary due to relapse, which then will be considered as one of the outcomes parameters. All toddlers meeting the inclusion criteria will be invited to join the study. After receiving the patient information file as well as the explanation of the trial objectives and set up, legal guardians of the children will be ask to sign informed consent form. All participants will also receive an information file on importance of proper intake of fluids and fibre rich foods for maintenance of the normal stool consistency. All participating toddlers will be randomly allocated to receive either Friso Comfort Next or another Comfort formula for the period of 2 months, which they will consume according to standard feeding tables provided by the respective manufacturer. During the intervention period parents will be asked to monitor the child’s digestion (stool consistency, defecation frequency) and digestive comfort parameters (comfort questionnaires, crying diaries) with use of different questionnaires and diaries. No biological samples will be collected at any time during this study. Number of doctors’ visits, their purpose and prescribed medication will also be registered. Overall anthropometric (body weight and length) measures will be collected at the beginning and end of the study. CONDITION: functional constipation, toddlers PRIMARY OUTCOME: Difference in maintenance of good digestion measured as normal stool consistency in toddlers who were diagnosed and received medical treatment for functional constipation.; ; The difference will be measured as the % of total reported hard stools (stool consistency) (Bristol Stool Chart I & II) between study groups consuming different Comfort YCF products; SECONDARY OUTCOME: a) Stool frequency (as number of defecations per week) ; b) GI tolerance questionnaires QPGS‐RIII section E – once a week ; c) % of subjects reporting any hard stools ; d) Modified crying diary, reluctance to defecate/go to potty or toilet‐ questions will be added to the Bristol stool chart to provide information if defecation was painful and if child was crying/avoiding etc. ; e) number of doctor’s visits of child in intervention period, number of prescribed laxatives in intervention period (as a measure of relapse). ; INCLUSION CRITERIA: Otherwise healthy toddlers with functional constipation (12 months till 32 months of age) – referred to a paediatrician, after standard medical treatment for constipation based on Rome III criteria’s • Full‐term, healthy toddlers (born at gestational age ≥37 weeks). • “Appropriate for gestational ageâ€� birthweight (i.e. 10th centile ≤ Birth weight ≤ 90th centile). • Age at enrolment: between 12 months and 32 months • Formula fed toddlers before and during the entire intervention period. • Parents willing to sign the written informed consent • Toddlers with a history of hard stools, for that reason referred to a paediatrician/ paediatric gastroenterologist, • Toddlers with functional constipation – based on Rome III criteria ‐ after standard medical treatment for constipation with PEG (Poyethylene Glycol) 1,5g/kg of body weight.