N/A
N=22
Effect of Inulin-type Fructans on Constipated Children.
Constipation
Bottom Line
View on ClinicalTrials.gov: NCT02863848 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Stool Consistency — 2.57; 1.63 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- OraftiR inulin-type fructans (Dietary_supplement); Placebo (Dietary_supplement)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Institut Investigacio Sanitaria Pere Virgili
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stool Consistency |
2.57; 1.63 | — |
| SECONDARY Stool Frequency |
— | — |
| SECONDARY Abdominal Pain |
— | — |
| SECONDARY Pain During Defecation |
— | — |
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.
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).
Data sourced from ClinicalTrials.gov (NCT02863848). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.