CompletedNot Applicable

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

China100 participantsStarted 2019-08-19

Plain-language summary

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

Who can participate

Age range

1 Year – 3 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Stool consistency

Timeframe: 4 weeks

Trial details

NCT IDNCT03941925

SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-10-26

View on ClinicalTrials.gov More Constipation trials