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

Primary Purpose

Constipation

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Prebiotic fructans

Non-prebiotic maltodextrin

About this trial

This is an interventional treatment trial for Constipation focused on measuring prebiotic

Eligibility Criteria

1 Year - 3 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Shanghai Xinhua Hospital, affiliated to Shanghai Jiao Tong University, School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Prebiotic fructans

Maltodextrin

Arm Description

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

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

Outcomes

Primary Outcome Measures

Stool consistency

Assessed by the parents in a continuous daily bowel diary over the study period using the Amsterdam Infant Stool Scale (AISS) comprised of a 4-point scale (A: watery, B: soft, C: formed, D: hard)

Secondary Outcome Measures

Stool frequency

Assessed by daily parental reporting.

Stool amount and stool colour

Assessed by the parents in a continuous daily bowel diary over the study period using the Amsterdam Infant Stool Scale (AISS). Stool amount will be assessed on a 4-point scale (1: smear, 2: up to 25%, 3: 25.50%, 4: >50%, relative to diaper surface). Stool colour will be assessed on a 6-point scale (I: yellow, II: orange, III: green, IV: brown, V: meconium, VI: clay-coloured)

Treatment success

ROME IV criteria still met at the end of the intervention.

Faecal microbiota

Stool samples will be analyzed by appropriate molecular biological methods like 16S rRNA gene sequencing to gain insight into the composition of the gut microbiota. Furthermore, metabolites like SCFA and other organic acids will be measured with appropriate chromatographic methods.

Faecal Short Chain Fatty Acids concentration

Change in Short Chain Fatty Acids over a four week period.

Faecal pH

Change in faecal pH over a four week period.

Full Information

NCT ID

NCT03941925

First Posted

May 6, 2019

Last Updated

July 8, 2021

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Collaborators

Beneo GmbH

1. Study Identification

Unique Protocol Identification Number

NCT03941925

Brief Title

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

Acronym

CONSTICHILD

Official Title

Double-blind, Randomized Placebo-controlled Trial Investigating the Effect of Prebiotic Fructans on Bowel Habits of Constipated Young Children One to Three Years of Age

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Unknown status

Study Start Date

July 1, 2019 (Actual)

Primary Completion Date

December 2022 (Anticipated)

Study Completion Date

December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Collaborators

Beneo GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Constipation

Keywords

prebiotic

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Prebiotic fructans

Arm Type

Experimental

Arm Description

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

Arm Title

Maltodextrin

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Prebiotic fructans

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Non-prebiotic maltodextrin

Intervention Description

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

Primary Outcome Measure Information:

Title

Stool consistency

Description

Assessed by the parents in a continuous daily bowel diary over the study period using the Amsterdam Infant Stool Scale (AISS) comprised of a 4-point scale (A: watery, B: soft, C: formed, D: hard)

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Stool frequency

Description

Assessed by daily parental reporting.

Time Frame

4 weeks

Title

Stool amount and stool colour

Description

Time Frame

4 weeks

Title

Treatment success

Description

ROME IV criteria still met at the end of the intervention.

Time Frame

4 weeks

Title

Faecal microbiota

Description

Time Frame

4 weeks

Title

Faecal Short Chain Fatty Acids concentration

Description

Change in Short Chain Fatty Acids over a four week period.

Time Frame

4 weeks

Title

Faecal pH

Description

Change in faecal pH over a four week period.

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

3 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of functional constipation following ROME4 criteria. Subject is otherwise healthy at the time of pre-examination. Subject is aged 1-3 years at the time of pre-examination. Subject and caretaker are able and willing to follow the study instructions. Subject is suitable for participation in the study according to the investigator/physician/study personnel. Written informed consent is given by parent or legal guardian. Exclusion Criteria: No legal guardian's command of any local language. Organic causes of defecation disorders incl. Hirschsprung disease, Spina bifida, hypothyroidism etc. Other metabolic or renal abnormalities or mental retardation (Child's mental delay). Food allergies or intolerances. Using drugs (e.g. antibiotics) influencing gastrointestinal function (4 weeks before run-in, 6 weeks before intervention). Use of laxatives and labelled pre- and probiotics in the previous 2 weeks before the beginning of run-in (4 weeks before intervention) Subjects who are currently involved or will be involved in another clinical or food study

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wei Cai, Doctor

Phone

021-25078674

Ext

021-25078674

caiw1978@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Weihui Yan, Doctor

Phone

021-25078674

Ext

021-25078674

yanweihui1982@sina.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wei Cai, Doctor

Organizational Affiliation

Xin Hua Hospital，School of Medicine, Shanghai Jiaotong University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Weihui Yan, Doctor

Organizational Affiliation

Xin Hua Hospital，School of Medicine, Shanghai Jiaotong University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Ying Wang, Doctor

Organizational Affiliation

Xin Hua Hospital，School of Medicine, Shanghai Jiaotong University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Lina Lu, Doctor

Organizational Affiliation

Xin Hua Hospital，School of Medicine, Shanghai Jiaotong University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

YIjing Tao

Organizational Affiliation

Xin Hua Hospital，School of Medicine, Shanghai Jiaotong University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Haixia Feng

Organizational Affiliation

Xin Hua Hospital，School of Medicine, Shanghai Jiaotong University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Yinghong Chen

Organizational Affiliation

Xin Hua Hospital，School of Medicine, Shanghai Jiaotong University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Anna Li

Organizational Affiliation

Xin Hua Hospital，School of Medicine, Shanghai Jiaotong University

Official's Role

Study Chair

Facility Information:

Facility Name

Shanghai Xinhua Hospital, affiliated to Shanghai Jiao Tong University, School of Medicine

City

Shanghai

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wei Cai, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

27931142

Citation

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.

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

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