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

Shanghai Jiao Tong University

Status: Unknown

Conditions: Constipation

Treatments: Dietary Supplement: Non-prebiotic maltodextrin; Dietary Supplement: Prebiotic fructans

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03941925

XH-18-016

Details and patient eligibility

About

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

Full description

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).

Enrollment: 100 estimated patients

Sex: All

Ages: 1 to 3 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Prebiotic fructans

Experimental group

Description:

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

Treatment:

Dietary Supplement: Prebiotic fructans

Maltodextrin

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Non-prebiotic maltodextrin