Prebiotic Fructans Effect on 1-3 Years Constipated Children's Bowel Habits

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2022-12-31

Brief Summary

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The aim of the study is to confirm the effectiveness of chicory-derived prebiotic inulin-type fructans on bowel function in young children.

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Detailed Description

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The aim of the study is to confirm the effectiveness of chicory-derived prebiotic inulin-type fructans on bowel function in young children. It is a double-blind, randomized, placebo-controlled trial.This study plans to recruit into the group of 100 participants (at least 80 of them completed) in 2018-2020.The two groups for the study are product group (prebiotic fructans) and control group (placebo maltodextrin).Duration of intervention is 6 weeks, including 2 weeks for run-in and 4 weeks for intervention.Efficacy parameters are stool consistency (assessed with Amsterdam infant stool scale),stool frequency, stool amount and stool color (assessed with Amsterdam infant stool scale, treatment success, tolerance and acceptability).

Conditions

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Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Prebiotic fructans

Prebiotic fructans. Prebiotic will be mixed into foods or drinks and consumed twice daily.

Group Type EXPERIMENTAL

Prebiotic fructans

Intervention Type DIETARY_SUPPLEMENT

Prebiotic group receiving the prebiotic fructans in two doses during the 4-week intervention period.

Maltodextrin

Maltodextrin. Maltodextrin will be mixed into foods or drinks and consumed twice daily.

Group Type PLACEBO_COMPARATOR

Non-prebiotic maltodextrin

Intervention Type DIETARY_SUPPLEMENT

Placebo group receiving the non-prebiotic maltodextrin in two doses during the 4-week intervention period.

Interventions

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Prebiotic fructans

Prebiotic group receiving the prebiotic fructans in two doses during the 4-week intervention period.

Intervention Type DIETARY_SUPPLEMENT

Non-prebiotic maltodextrin

Placebo group receiving the non-prebiotic maltodextrin in two doses during the 4-week intervention period.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of functional constipation following ROME4 criteria.
2. Subject is otherwise healthy at the time of pre-examination.
3. Subject is aged 1-3 years at the time of pre-examination.
4. Subject and caretaker are able and willing to follow the study instructions.
5. Subject is suitable for participation in the study according to the investigator/physician/study personnel.
6. Written informed consent is given by parent or legal guardian.

Exclusion Criteria

1. No legal guardian's command of any local language.
2. Organic causes of defecation disorders incl. Hirschsprung disease, Spina bifida, hypothyroidism etc.
3. Other metabolic or renal abnormalities or mental retardation (Child's mental delay).
4. Food allergies or intolerances.
5. Using drugs (e.g. antibiotics) influencing gastrointestinal function (4 weeks before run-in, 6 weeks before intervention).
6. Use of laxatives and labelled pre- and probiotics in the previous 2 weeks before the beginning of run-in (4 weeks before intervention)
7. Subjects who are currently involved or will be involved in another clinical or food study

Minimum Eligible Age

1 Year

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR