ConstipationCONSTICHILDNCT03941925

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

A study testing Prebiotic fructans and Non-prebiotic maltodextrin in people with Constipation, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 1 year to 3 years
Conditions the study is for: Constipation
What is being tested?: Prebiotic fructans and Non-prebiotic maltodextrin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 100 participants
Where: 1 siteChina
Study dates: 19 Aug 2019to 26 Oct 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 1 year to 3 years
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

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

Other trials in China

About this study

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

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

Read the 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).

Conditions: Constipation
Being tested: Prebiotic fructans, Non-prebiotic maltodextrin
Keywords: prebiotic
Medical subject headings: Constipation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Prebiotic fructansDietary supplement
Prebiotic group receiving the prebiotic fructans in two doses during the 4-week intervention period.
Non-prebiotic maltodextrinDietary supplement
Placebo group receiving the non-prebiotic maltodextrin in two doses during the 4-week intervention period.

Study groups in NCT03941925
Study group	Role	What they receive
Prebiotic fructans	Experimental	Prebiotic fructans. Prebiotic will be mixed into foods or drinks and consumed twice daily. Receives: Dietary Supplement: Prebiotic fructans
Maltodextrin	Placebo comparator	Maltodextrin. Maltodextrin will be mixed into foods or drinks and consumed twice daily. Receives: Dietary Supplement: Non-prebiotic maltodextrin

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 4 weeks

Secondary outcomes (6)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Aug 201926 Oct 2021

First posted8 May 2019
Study start19 Aug 2019
Primary completion26 Oct 2021
Study completion26 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for ConstipationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03941925
Sponsor's protocol ID: XH-18-016
Acronym: CONSTICHILD
Status last verified: May 2026
First submitted: 6 May 2019
Last updated: 12 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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.
PubMed 27931142

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
Recruiting
Effects of Connective Tissue Massage Plus Biofeedback for Dyssynergic Defecation
Dyssynergic Defecation

All Constipation trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03941925
Acronym / sponsor ID: CONSTICHILD / XH-18-016
Conditions: Constipation
Keywords: prebiotic
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
Collaborators: Beneo GmbH
Study start: 19 Aug 2019 (actual)
Primary completion: 26 Oct 2021 (actual)
Study completion: 26 Oct 2021 (actual)
First posted: 8 May 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Prebiotic fructans	Experimental	Dietary Supplement: Prebiotic fructansPrebiotic fructans. Prebiotic will be mixed into foods or drinks and consumed twice daily.
Maltodextrin	Placebo comparator	Dietary Supplement: Non-prebiotic maltodextrinMaltodextrin. Maltodextrin will be mixed into foods or drinks and consumed twice daily.

Who may qualify

Ages: 1 year to 3 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (7 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Prebiotic fructansPrebiotic group receiving the prebiotic fructans in two doses during the 4-week intervention period.	Dietary supplement	Prebiotic fructans
Non-prebiotic maltodextrinPlacebo group receiving the non-prebiotic maltodextrin in two doses during the 4-week intervention period.	Dietary supplement	Maltodextrin

Primary outcome

Stool consistency
Time frame: 4 weeks
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)

6 secondary outcomes

Stool frequency
Time frame: 4 weeks
Stool amount and stool colour
Time frame: 4 weeks
Treatment success
Time frame: 4 weeks
Faecal microbiota
Time frame: 4 weeks
Faecal Short Chain Fatty Acids concentration
Time frame: 4 weeks
Faecal pH
Time frame: 4 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
Background: PubMed 27931142Closa-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.
Individual participant dataSharing planned: No

Related trials for Constipation

Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
Recruiting
Effects of Connective Tissue Massage Plus Biofeedback for Dyssynergic Defecation
Dyssynergic Defecation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Wei Cai, Doctor principal investigator

Xin Hua Hospital，School of Medicine, Shanghai Jiaotong University

Weihui Yan, Doctor study director

Xin Hua Hospital，School of Medicine, Shanghai Jiaotong University

Ying Wang, Doctor study chair

Xin Hua Hospital，School of Medicine, Shanghai Jiaotong University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Prebiotic fructans and Non-prebiotic maltodextrin in people with Constipation, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stool consistency (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03941925, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.