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RecruitingTherapeutic confirmatory (Phase III)Interventional

Randomized controlled clinical trial on prophylactic treatment of constipation with polyethylene glycol with electrolytes in the critically ill child.

When children are very unwell in hospital, being in bed and taking strong medicines can often cause constipation. Constipation can be painful and may slow down a child's recovery. This clinical trial is testing a common medicine called Movicol Paediatric. Movicol is a powder mixed with water that helps keep water in the bowel, softening the stool. In this study, doctors want to see if giving Movicol early—before constipation even starts—helps critically ill children pass stools normally. The research team will record how often each child passes a stool and check how soft it is using a standard medical scale. They will also carefully watch for any unwanted side effects to ensure the treatment is safe.

At a glance

Status
Recruiting
Phase
Therapeutic confirmatory (Phase III)
Sponsor
Hospital General Universitario Gregorio Maranon
Enrolment target
233
Start
04 Feb 2025

What is this study about?

When a child is admitted to hospital with a serious illness, their body goes through a lot of stress. Treatments such as pain relief, along with lying still in bed for long periods, frequently slow down the digestive system. This often leads to constipation, which can cause tummy pain, bloating, and distress during an already difficult time.

Movicol Paediatric is a gentle, widely used treatment. It contains an ingredient called polyethylene glycol, along with essential salts called electrolytes. Unlike harsh medicines that force the bowel to squeeze, Movicol works naturally by holding onto water. This makes the stool softer and easier to pass.

This Phase 3 trial aims to find out if giving Movicol as a preventative step—rather than waiting for constipation to happen—is effective and safe for critically ill children. Doctors will compare children receiving the medicine with standard care to see if it leads to regular, comfortable bowel movements.

Finding better ways to manage constipation is an important part of hospital care. If this approach works well, it could help young patients feel more comfortable, avoid complications, and focus on getting better.

Key takeaways

  • Testing whether Movicol prevents constipation in seriously ill children.
  • Movicol is a gentle, commonly used medicine that softens stools.
  • Bowel movements and stool softness will be tracked during the hospital stay.
  • The study takes place entirely in the hospital with continuous medical monitoring.
  • Taking part is voluntary, and you can withdraw your child at any time.

Who may be eligible?

This trial is for babies, children, and young people who are being cared for in hospital with a serious or critical illness. Both boys and girls can take part.

Because these children are already being closely looked after by hospital doctors, the medical team will check whether it is safe for them to receive Movicol. Children who have certain bowel blockages or specific digestive conditions may not be able to join.

Parents or legal guardians will always be asked for their permission before a child is enrolled in the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. The patient is a child or young person currently staying in hospital.
  2. The child is considered critically ill or being treated in intensive care.
  3. The child is at risk of developing constipation during their stay.
  4. The child can safely receive liquids by mouth or through a feeding tube.
  5. A parent or legal guardian is available to give informed consent.
Answer every question to see your result.

What does participation involve?

Because this study takes place in the hospital, you will not need to make any extra trips. If you agree for your child to take part, the medical team will give them Movicol Paediatric as a liquid drink or through a feeding tube if they cannot swallow. Nurses and doctors will track how often your child opens their bowels and use a simple visual guide (called the Bristol Stool Chart) to note the consistency of the stool. The team will also monitor your child closely for any side effects. The study lasts for the time your child is being treated in the unit, and routine hospital care will carry on as normal.

Potential risks and benefits

The main hope is that this treatment helps prevent uncomfortable constipation, making your child feel more settled while in hospital. However, all medicines carry some risks. Movicol can sometimes cause mild tummy rumbles, wind, or loose stools (diarrhoea). The hospital team will monitor your child 24 hours a day to manage any symptoms quickly. Taking part is completely voluntary. You can choose to stop your child's participation at any point, and their standard NHS care will not be affected in any way.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • —
    Unverified
    Spain

Common questions

What is Movicol Paediatric?

Movicol Paediatric is a gentle, flavour-free powder that dissolves in water. It is commonly prescribed to children to soften hard stools and relieve or prevent constipation.

Can my child take part if they have a feeding tube?

Yes. If your child cannot drink fluids normally, the dissolved medicine can usually be given through their feeding tube.

Will this trial change my child's other medical care?

No. Your child will continue to receive all the specialist care, medicines, and monitoring they need for their main illness.

What is the Bristol Stool Scale?

It is a simple medical chart showing pictures of different types of poo, from hard lumps to watery liquid. It helps doctors and nurses clearly describe stool consistency.

Do we have to pay anything to take part?

No. Clinical trials in the hospital are free of charge, and joining will never cost you anything.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Randomized controlled clinical trial on prophylactic treatme…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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