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

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

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

Study Overview

• Status: Recruiting
• Conditions: Constipation
• Intervention / Treatment: Dietary supplement: Prebiotic fructans; Dietary supplement: Non-prebiotic maltodextrin

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).

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wei Cai, Doctor; Phone Number: 021-25078674 021-25078674; Email: caiw1978@163.com
• Study Contact Backup: Name: Weihui Yan, Doctor; Phone Number: 021-25078674 021-25078674; Email: yanweihui1982@sina.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Shanghai Xinhua Hospital, affiliated to Shanghai Jiao Tong University, School of Medicine
    • Contact: Wei Cai, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prebiotic fructans; Prebiotic fructans. Prebiotic will be mixed into foods or drinks and consumed twice daily.	Dietary supplement: Prebiotic fructans; Prebiotic group receiving the prebiotic fructans in two doses during the 4-week intervention period.
Placebo Comparator: Maltodextrin; Maltodextrin. Maltodextrin will be mixed into foods or drinks and consumed twice daily.	Dietary supplement: Non-prebiotic maltodextrin; Placebo group receiving the non-prebiotic maltodextrin in two doses during the 4-week intervention period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stool frequency	Assessed by daily parental reporting.	4 weeks
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)	4 weeks
Treatment success	ROME IV criteria still met at the end of the intervention.	4 weeks
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.	4 weeks
Faecal Short Chain Fatty Acids concentration	Change in Short Chain Fatty Acids over a four week period.	4 weeks
Faecal pH	Change in faecal pH over a four week period.	4 weeks

Collaborators and Investigators

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Collaborators: Beneo GmbH
• Investigators: Principal Investigator: Wei Cai, Doctor, Xin Hua Hospital，School of Medicine, Shanghai Jiaotong University; Study Director: Weihui Yan, Doctor, Xin Hua Hospital，School of Medicine, Shanghai Jiaotong University; Study Chair: Ying Wang, Doctor, Xin Hua Hospital，School of Medicine, Shanghai Jiaotong University; Study Chair: Lina Lu, Doctor, Xin Hua Hospital，School of Medicine, Shanghai Jiaotong University; Study Chair: YIjing Tao, Xin Hua Hospital，School of Medicine, Shanghai Jiaotong University; Study Chair: Haixia Feng, Xin Hua Hospital，School of Medicine, Shanghai Jiaotong University; Study Chair: Yinghong Chen, Xin Hua Hospital，School of Medicine, Shanghai Jiaotong University; Study Chair: Anna Li, Xin Hua Hospital，School of Medicine, Shanghai Jiaotong University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: May 6, 2019
• First Submitted That Met QC Criteria: May 6, 2019
• First Posted (Actual): May 8, 2019

Study Record Updates

• Last Update Posted (Actual): July 12, 2021
• Last Update Submitted That Met QC Criteria: July 8, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: prebiotic
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation; Antineoplastic Agents; Levan
• Other Study ID Numbers: XH-18-016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No