functional constipation, toddlers
Conditions
Interventions
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 w
Sponsors
Joshué Covarrubias GI Pediatrician: B. Nois de México SA de CV ; Av. Tepeyac 4251-6, Col. Prados Tepeyac, CP 45050, Zapopan Jalisco, México,
Sergio Díaz madero GI Pediatrician: UNIDAD DE PEDIATRÍA S.C. (Pediatric Private Partnership)whose address is at AV. EJERCITO NACIONAL 613, INT 303. COLONIA GRANADA. 11520, MIGUEL HIDALGO. MEXICO CITY (CDMX), MEXICO
Eligibility
Inclusion criteria
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 age” 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.
Exclusion criteria
Exclusion criteria: • Severe acquired or congenital diseases, mental, metabolic or physical disorders, any symptoms of allergy (including cow’s milk allergy [CMA]). • No parents or siblings with documented CMA, diagnosed by a doctor. • Diagnosed gastrointestinal diseases (e.g. celiac disease, Hirschsprung disease etc.) with exception of constipation • Unwillingness to stop the use of supplements with fibers, probiotics and prebiotics two weeks before and for the duration of the study. • Considered to be non-responder, i.e. more than 5x unsuccessful treatment with laxatives. • Use of medication(s) known or suspected to affect fat digestion, absorption and/or metabolism; nutritional supplements; suppositories; medication that may suppress or neutralize gastric acid secretion and gut mobility at the time of screening or at any time throughout the study period (these children will be considered as drop-outs). • Participation in another clinical trial. • Breast feeding 1 month before study enrollment • Perceived lactose intolerance • Constipation attributable to organic or anatomic causes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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). | — |
Contacts
Public ContactUrszula Kudla
FrieslandCampina Innovation Centre Mailing address: P.O. Box 238 6700 AE Wageningen
Outcome results
None listed