Clinical trial NCT02863848: Effect of Inulin-type Fructans on Constipated Children.
Official title: Effect of Inulin-type Fructans on Constipated Children. Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation
Lead sponsor: Institut Investigacio Sanitaria Pere Virgili
Sponsor class: OTHER
Collaborators: name: Beneo GmbH
First posted: 2016-08-11
Enrollment: 22
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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).

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:

  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).

Primary outcomes:
measure: Stool Consistency
timeFrame: 6 weeks of treatment
Secondary outcomes:
measure: Stool Frequency
timeFrame: 6 weeks of treatment
measure: Abdominal Pain
timeFrame: 6 weeks of treatment
measure: Pain During Defecation
timeFrame: 6 weeks of treatment
Other outcomes:
Locations:
city: Reus
country: Spain
facility: Iispv- Hospital Sant Joan de Reus
state: Tarragona
Study officials:
affiliation: Universitat Rovira i Virgili, IISPV
name: Joaquin Escribano, Prof PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Closa-Monasterolo R, Ferre N, Castillejo-DeVillasante G, Luque V, Gispert-Llaurado M, Zaragoza-Jordana M, Theis S, Escribano J. The use of inulin-type fructans improves stool consistency in constipated children. A randomised clinical trial: pilot study. Int J Food Sci Nutr. 2017 Aug;68(5):587-594. doi: 10.1080/09637486.2016.1263605. Epub 2016 Dec 8.