Effect of Inulin-type Fructans on Constipated Children.

NCT02863848 | Completed Results

• 1 other identifier: CONSTICHILD
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation

Outcome Measures

Primary Outcomes (1)

• Stool Consistency

  Stool consistency was measured according to the Modified Bristol Stool Form Scale for children (from 1 to 5, having lower scores a more hard stool characteristics). Assessed by a continuous daily bowel diary over the following period and in accordance with the Modified Bristol Stool Form Scale for Children. The average consistency from all depositions reported in each follow-up period was obtained for each participant.

  6 weeks of treatment

Secondary Outcomes (3)

• Stool Frequency

  6 weeks of treatment

• Abdominal Pain

  6 weeks of treatment

• Pain During Defecation

  6 weeks of treatment

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Maltodextrin 2g, twice per day, 6 weeks

Dietary Supplement: Placebo

Inulin-type fructans

ACTIVE COMPARATOR

Orafti inulin-type fructans 2g, twice per day, 6 weeks

Dietary Supplement: OraftiR inulin-type fructans

Interventions

OraftiR inulin-type fructans DIETARY_SUPPLEMENT

Inulin-type fructans

Placebo DIETARY_SUPPLEMENT

maltodextrin

Placebo

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Institut Investigacio Sanitaria Pere Virgili: lead
• Beneo GmbH: collaborator

Study Sites (1)

Iispv- Hospital Sant Joan de Reus

Reus, Tarragona, E43204, Spain

Location

Related Publications (1)

• 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.

  PMID: 27931142 DERIVED

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Joaquin Escribano
• Organization: Universitat Rovira i virgili

joaquin.escribano@urv.cat

+ 34 977 759364

Study Officials

• Joaquin Escribano, Prof PhD

  Universitat Rovira i Virgili, IISPV

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Paediatrics, Nutrition and Human Development Research Unit Universitat Rovira i Virgili - IISPV

Study Record Dates

• First Submitted: April 4, 2016
• First Posted: August 11, 2016
• Study Start: September 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: January 1, 2014
• Last Updated: July 29, 2024
• Results First Posted: July 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)