Effect of Inulin-type Fructans on Constipated Children.

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).

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:

• Two or fewer defecations per week
• At least 1 episode per week of incontinence after the acquisition of toileting skills
• History of excessive stool retention
• History of painful or hard bowel movements
• Presence of a large faecal mass in the rectum
• 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).