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Can a chicory fiber ease toddler constipation?

NCT ID NCT03941925

Disease control Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This trial tests whether a prebiotic fiber from chicory, called fructans, can improve bowel habits in young children aged 1 to 3 with constipation. Half of the 100 participants will receive the prebiotic daily for four weeks, while the other half gets a placebo. Parents will track stool consistency, frequency, and amount in a daily diary to see if the fiber helps.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Prebiotic fructans (chicory-derived inulin-type)
What this could lead to
If effective, this could offer a gentle, natural dietary supplement to ease constipation in young children, potentially reducing reliance on laxatives.
What could go wrong
This is an early-stage trial with a modest size, and results may not apply to all children. The supplement could cause digestive discomfort like gas or bloating.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

100 people

The number who actually took part.

Started

Aug 2019

Finished

Oct 2021

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 year to 3 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

constipation disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Constipation

Contacts and locations

Locations

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

    Shanghai, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.