Effect of Inulin-type Fructans on Constipated Children.

NCT ID: NCT02863848

Last Updated: 2024-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2014-01-31

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).

Conditions

Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Maltodextrin 2g, twice per day, 6 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

maltodextrin

Inulin-type fructans

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

Group Type: ACTIVE_COMPARATOR

OraftiR inulin-type fructans

Intervention Type: DIETARY_SUPPLEMENT

Interventions

OraftiR inulin-type fructans

Intervention Type: DIETARY_SUPPLEMENT

Placebo

maltodextrin

Intervention Type: DIETARY_SUPPLEMENT

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).

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beneo GmbH

INDUSTRY

Sponsor Role: collaborator

Institut Investigacio Sanitaria Pere Virgili

OTHER

Sponsor Role: lead

Responsible Party

Dr. Joaquin Escribano

Head of the Paediatrics, Nutrition and Human Development Research Unit Universitat Rovira i Virgili - IISPV

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joaquin Escribano, Prof PhD

Role: PRINCIPAL_INVESTIGATOR

Universitat Rovira i Virgili, IISPV

Locations

Iispv- Hospital Sant Joan de Reus

Reus, Tarragona, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 27931142 (View on PubMed)

Other Identifiers

CONSTICHILD

Identifier Type: -

Identifier Source: org_study_id