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Sitting or lying down? new study aims to improve constipation diagnosis in children

NCT ID NCT06924957

Knowledge-focused Sponsor: Medical University of Warsaw 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Aug 20, 2026 · Updated 2 times

Summary

This study looks at whether a child's body position (sitting vs. lying down) changes the results of a test that measures anal and rectal pressures. Researchers will compare these positions in 120 children aged 5 to 18, some with constipation and some without. The goal is to find the best way to diagnose problems with how the bowel works.

What this could mean

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

What this could lead to
If successful, this could help doctors diagnose constipation-related problems more accurately in children by using the best testing position.
What could go wrong
This is an early observational study, not a treatment trial. It may not change current practice or benefit participants directly.

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.

Participants

84 people

The number who actually took part.

Started

Jan 2020

Finished

Aug 2026

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.

Who is studied

The sample size was calculated to detect a 45% difference in the percentage of patients with a negative rectoanal gradient, assuming equal groups, alpha = 0.05, beta = 0.1, and a 30% drop out percentage. There should be 30 people in the constipation group and 30 healthy volunteers. Due to possible differences depending on age, it was decided to conduct the study in two separate age groups (I. younger, i.e. 5-10 years old and II. older, 11-18 years old). The total number of patients in the study will therefore be 120 people.

Ages

4 to 18 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 - the study group: * age from 5 to 18 years old * functional constipation diagnosed on the basis of Rome IV criteria * parental or guardian written consent to the participation of the child in the study; in the case of a child ≥16 years old also the child's written consent Inclusion criteria - the control group: * age from 5 to 18 years old * no lower gastrointestinal symptoms * parental or guardian written consent to the participation of the child in the study; in the case of a child ≥16 years old also the child's written consent Exclusion criteria - the study group and the control group: * undergone surgeries due to congenital anomalies in the lower gastrointestinal tract * inflammatory bowel diseases or inflammation of the large intestine with a different aetiology * anal fissure, inflammation of the anal area or other conditions which, in the opinion of the researcher, could affect the functioning of the distal gastrointestinal tract

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Conditions

The condition(s) this trial relates to.

constipation disorder rectal disorder

As listed by the trial registrant

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

Anorectal disorder Children Constipation

Contacts and locations

Locations

  • The Department of Paediatric Gastroenterology and Nutrition, Warsaw Medical University

    Warsaw, Masovian Voivodeship, 02-091, Poland

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