Effect of Inulin-type Fructans on Constipated Children. (CONSTICHILD)

Pere Virgili Health Research Institute (IISPV)

Status

Completed

Conditions

Constipation

Treatments

Dietary Supplement: Placebo

Dietary Supplement: OraftiR inulin-type fructans

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02863848

CONSTICHILD

Details and patient eligibility

About

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.

Full description

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).

Enrollment

22 patients

Sex

All

Ages

2 to 5 years old

Volunteers

No Healthy Volunteers

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).