effect of inulin-type fructans on constipated children.

Conditions: Constipation

Summary: the main objective of this pilot study was to assess the beneficial effects of a daily supplementation with orafti inulin-type fructans in 2-5 year old constipated children the study is primary aimed to develop a feasibility study to assess the beneficial effect of inulin-type fructans in the described population with regard to the adequate criteria for a larger trial. secondary objectives are to obtain data about the feasibility of the protocol (as pilot study). to obtain data useful to perform sample size calculations for a big study designed specifically to investigate the beneficial effect of inulin-type fructans in the treatment of constipated children. study design and subjects: double-blind, randomized, placebo-controlled parallel group trial; where 2-5 year-old constipated children received inulin-type fructans or the same amount of placebo (maltodextrin) during 6 weeks. the study protocol was approved by the local ethical committees. outcomes: primary outcome was stool consistency. secondary outcomes were: stool frequency, gastrointestinal symptoms (abdominal pain and pain during defecation), additional medication required (yes/no), and colonic transit time. stool samples at baseline, end of intervention and after follow-up were obtained in order to be analysed to know about the microbiota. dietary intake was also recorded at baseline, end of intervention and after follow-up. principal subject inclusion criteria: subjects were recruited if fulfil the rome iii constipation criteria (mainly hard stools plus stool retention, or pain, or low frequency). principal subject exclusion criteria: age under 2 or over 5 years, diapers use, use of laxative during the study and 2 weeks before, use of pre- probiotics or antibiotics during the study and 4 weeks before, organic causes of defecation disorders, other metabolic or renal abnormalities or mental retardation, no parent's command of any local language.

double-blind, randomised, placebo-controlled parallel group trial (pilot) constipated children received two doses of 2g orafti® inulin-type fructans (of:in) or placebo (maltodextrin) for 6 weeks. primary outcome was stool consistency. secondary outcomes were stool frequency and gastrointestinal symptoms. sample size recruited: twenty-two children, from whom 17 completed the study protocol (nine for the of:in and eight for the control group).

Eligibility criteria:
inclusion criteria: * two to 5 year-old constipated children with sufficient toilet training. * to acomplish the romee i criteria for infants up to 4 yeras. briefly: have to fulfil at least 2 of the following criteria for at least 1 month: 1. two or fewer defecations per week 2. at least 1 episode per week of incontinence after the acquisition of toileting skills 3. history of excessive stool retention 4. history of painful or hard bowel movements 5. presence of a large faecal mass in the rectum 6. history of large-diameter stools that may obstruct the toilet accompanying symptoms may include irritability, decreased appetite and/or early satiety. accompanying symptoms disappear immediately following passage of a large stool. exclusion criteria: * no child's control of defecation (use of diapers). * no mother's command of any local language. * organic causes of defecation disorders incl. hirschsprung's disease, spina bifida, hypothyroidism, celiac disease etc. * other metabolic or renal abnormalities or mental retardation (child's mental delay). * use of drugs (e.g. antibiotics) and labelled pre- and probiotics influencing gastrointestinal function (4 weeks before run-in, 6 weeks before intervention). * use of laxatives in the previous 2 weeks before the beginning of run-in (4 weeks before intervention).