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
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2019
CompletedFirst Posted
Study publicly available on registry
May 8, 2019
CompletedStudy Start
First participant enrolled
July 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedJuly 12, 2021
July 1, 2021
3.4 years
May 6, 2019
July 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Stool frequency
4 weeks
Stool amount and stool colour
4 weeks
Treatment success
4 weeks
Faecal microbiota
4 weeks
Faecal Short Chain Fatty Acids concentration
4 weeks
- +1 more secondary outcomes
Study Arms (2)
Prebiotic fructans
EXPERIMENTALPrebiotic fructans. Prebiotic will be mixed into foods or drinks and consumed twice daily.
Maltodextrin
PLACEBO COMPARATORMaltodextrin. Maltodextrin will be mixed into foods or drinks and consumed twice daily.
Interventions
Prebiotic group receiving the prebiotic fructans in two doses during the 4-week intervention period.
Placebo group receiving the non-prebiotic maltodextrin in two doses during the 4-week intervention period.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Xinhua Hospital, affiliated to Shanghai Jiao Tong University, School of Medicine
Shanghai, China
Related Publications (1)
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.
PMID: 27931142BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2019
First Posted
May 8, 2019
Study Start
July 1, 2019
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
July 12, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share