Constipation Clinical Trial
Official title:
Effect of Inulin-type Fructans on Constipated Children. Pilot Study.
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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