Effect of Inulin-type Fructans on Constipated Children.

Constipation Clinical Trial

— CONSTICHILD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02863848
• Other study ID #: CONSTICHILD
• Status: Completed
• Phase: N/A
• First received: April 4, 2016
• Last updated: August 8, 2016
• Start date: September 2012
• Est. completion date: January 2014

Study information

• Verified date: August 2016
• Source: Institut Investigacio Sanitaria Pere Virgili
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 5 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation

Intervention

Dietary Supplement:
• OraftiR inulin-type fructans

• Placebo
maltodextrin

Locations

Country	Name	City	State
Spain	Iispv- Hospital Sant Joan de Reus	Reus	Tarragona

Sponsors (2)

Lead Sponsor	Collaborator
Institut Investigacio Sanitaria Pere Virgili	Beneo GmbH

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Stool frequency (Assessed by a continuous daily bowel diary and expressed as stools per week)		6 weeks of treatment	No
Secondary	Abdominal pain (Assessed by daily bowel diary and Wong-Baker FACES Pain Rating Scale)		6 weeks of treatment	No
Secondary	Pain during defecation (Assessed by daily bowel diary and Wong-Baker FACES Pain Rating Scale)		6 weeks of treatment	No