Clinical trial NCT03941925: Prebiotic Fructans Effect on 1-3 Years Constipated Children's Bowel Habits
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
Overall status: UNKNOWN
Phase: NA
Conditions: Constipation
Keywords: prebiotic
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Beneo GmbH
First posted: 2019-05-08
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Stool consistency
timeFrame: 4 weeks
Secondary outcomes:
measure: Stool frequency
timeFrame: 4 weeks
measure: Stool amount and stool colour
timeFrame: 4 weeks
measure: Treatment success
timeFrame: 4 weeks
measure: Faecal microbiota
timeFrame: 4 weeks
measure: Faecal Short Chain Fatty Acids concentration
timeFrame: 4 weeks
measure: Faecal pH
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Xinhua Hospital, affiliated to Shanghai Jiao Tong University, School of Medicine
Study officials:
affiliation: Xin Hua Hospital，School of Medicine, Shanghai Jiaotong University
name: Wei Cai, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Xin Hua Hospital，School of Medicine, Shanghai Jiaotong University
name: Weihui Yan, Doctor
role: STUDY_DIRECTOR
affiliation: Xin Hua Hospital，School of Medicine, Shanghai Jiaotong University
name: Ying Wang, Doctor
role: STUDY_CHAIR
affiliation: Xin Hua Hospital，School of Medicine, Shanghai Jiaotong University
name: Lina Lu, Doctor
role: STUDY_CHAIR
affiliation: Xin Hua Hospital，School of Medicine, Shanghai Jiaotong University
name: YIjing Tao
role: STUDY_CHAIR
affiliation: Xin Hua Hospital，School of Medicine, Shanghai Jiaotong University
name: Haixia Feng
role: STUDY_CHAIR
affiliation: Xin Hua Hospital，School of Medicine, Shanghai Jiaotong University
name: Yinghong Chen
role: STUDY_CHAIR
affiliation: Xin Hua Hospital，School of Medicine, Shanghai Jiaotong University
name: Anna Li
role: STUDY_CHAIR
References:
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.