Effect of Inulin-type Fructans on Constipated Children.

Study Overview
=================
Brief 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.

Official Title
-----------------
Effect of Inulin-type Fructans on Constipated Children. Pilot Study.

Conditions
-----------------
Constipation

Intervention / Treatment
-----------------
* Dietary Supplement: OraftiR inulin-type fructans
* Dietary Supplement: Placebo


Participation Criteria
=================
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: 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).

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 5 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Maltodextrin 2g, twice per day, 6 weeks | Dietary Supplement: Placebo<br>* maltodextrin<br>|
| Active Comparator: Inulin-type fructans<br>Orafti inulin-type fructans 2g, twice per day, 6 weeks | Dietary Supplement: OraftiR inulin-type fructans<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool consistency (Assessed by a continuous daily bowel diary over the following period and in accordance with the Modified Bristol Stool Form Scale for Children) |  | 6 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool frequency (Assessed by a continuous daily bowel diary and expressed as stools per week) |  | 6 weeks of treatment | 
| Abdominal pain (Assessed by daily bowel diary and Wong-Baker FACES Pain Rating Scale) |  | 6 weeks of treatment | 
| Pain during defecation (Assessed by daily bowel diary and Wong-Baker FACES Pain Rating Scale) |  | 6 weeks of treatment |