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Constipation - FunctionalNCT05191810

Efficacy of Educational Intervention as Supporting Element in the Treatment of Functional Constipation in Children

A study testing Educational information in people with Constipation - Functional, run by Medical University of Warsaw.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to determine whether educational intervention (recommendation of adequate fluid intake) is effective as an element supporting the treatment of functional constipation in children. Read more about this study

Who is it for?
Ages 1 year to 18 years
Conditions the study is for
Constipation - Functional
What is being tested?
Educational information
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
No sites listed yet
Study dates
7 Mar 2022to 30 Dec 2024
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 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Children with functional constipation diagnosed based on Rome IV criteria

Who cannot join

  • Children with organic causes of constipation; eg, anorectal malformations, or Hirschsprung's disease
  • Children who fulfil the criteria of Irritable Bowel Syndrome
  • Significant, unstabilised chronic health conditions requiring major drug adjustment during the last 3 months.
  • Unintentional weight loss greater than or equal to 5% of their body weight within the last 3 months
  • Recurrent or unexplained fevers
  • History of abdominal surgery involving the luminal gastrointestinal tract, except appendectomy, or hernia repairs
Show all 11Show fewer
  • Concomitant use of drugs that are known to affect gastrointestinal motility
  • Established diagnoses of autism spectrum disorders
  • Mental retardation
  • Children who are exclusively breastfed
  • Non-retentive faecal incontinence

Trial locations and contacts

No sites are listed yet.

Piotr Dziechciarz, MD PhD contact

+48223179539

piotr.dziechciarz@wum.edu.pl

About this study

The purpose of this study is to determine whether educational intervention (recommendation of adequate fluid intake) is effective as an element supporting the treatment of functional constipation in children.

Read the detailed description

Constipation is a common condition in children which affects around 10% of the paediatric population. In 95 % cases it is a functional disorder of the digestive tract, without any organic cause. Recommendations of lifestyle modifications accompanying pharmacological treatment of constipation are very popular among healthcare providers, although there is limited data concerning non-pharmacological treatment methods of this condition. Adequate for age fluid intake is now recommended for patients with constipation. Further research is needed to form stronger recommendations in the future. The purpose of this study is to determine whether educational intervention (recommendation of adequate fluid intake) is effective as an element supporting the treatment of functional constipation in children.

Being tested
Educational information
Keywords
fluid intake, functional constipation, children, PEG, macrogol, educational intervention

What participants receive

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

  • Educational informationBehavioural

    Educational information about non-pharmacological supporting treatment of functional constipation, involving recommendation of adequate for age fluid intake

Study groups in NCT05191810
Study groupRoleWhat they receive
Study GroupExperimentalMacrogol (PEG 3350, PEG 4000), standard dosage Educational intervention: Recommendation of adequate for age fluid intake plus standard information about non-pharmacological supporting treatment
Receives: Behavioral: Educational information
Control GroupNo interventionMacrogol (PEG 3350, PEG 4000), standard dosage Standard educational information about non-pharmacological supporting treatment

What is being measured

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

  1. Number of Participants who no longer fulfill the Rome IV constipation criteria

    Success of therapy defined as no longer fulfilling the Rome IV constipation criteria during the last week of intervention.

    Measured: last week of intervention

Secondary outcomes (9)

  1. Average daily fluid intake (ml) before the beginning of the intervention and during the last week of intervention

    Assessed by a 2-day food and fluid intake diary made by patient and/or caregiver at the beginning of the intervention and during the last week of intervention

    Measured: 8 weeks

  2. Frequency (number per week) of bowel movements during the fourth and last weeks of intervention

    One of the Rome IV constipation criteria

    Measured: 8 weeks

  3. Frequency of fecal incontinence (number per week) during the fourth and last weeks of intervention

    One of the Rome IV constipation criteria

    Measured: 8 weeks

  4. Painful bowel movements (number per week) during the fourth and last weeks of intervention

    One of the Rome IV constipation criteria

    Measured: 8 weeks

  5. Stomachache and bloating (number of episodes per week) during the fourth and last weeks of intervention

    Symptoms related to constipation

    Measured: 8 weeks

  6. Macrogol dose (mg/kg/day) during the fourth and last weeks of intervention

    Macrogol dose needed to achieve treatment success (no longer fulfilling the Rome IV constipation criteria).

    Measured: 8 weeks

  7. Need for rescue laxative treatment during the intervention (number of cases)

    In case of lack of bowel movements for three consecutive days, the macrogol dose will be augmented to 1-1.5g/kg/day until a bowel movement occurs.

    Measured: 8 weeks

  8. Time (days) from the start of intervention needed to achieve treatment success.

    Time needed to no longer fulfill the Rome IV constipation criteria

    Measured: 8 weeks

  9. Adverse events during intervention (number and type of reported adverse events)

    Any adverse events reported by the patient or caregiver

    Measured: 8 weeks

Timeline

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

  1. First posted14 Jan 2022
  2. Study start7 Mar 2022 (estimated)
  3. Primary completion30 Dec 2024 (estimated)
  4. Study completion30 Dec 2024 (estimated)

Resources

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05191810
Sponsor's protocol ID
ZAPWUM11/2021
Status last verified
Mar 2022
First submitted
29 Dec 2021
Last updated
3 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Plan to share data on request via e-mail

Publications

  • Koppen IJN, Vriesman MH, Saps M, Rajindrajith S, Shi X, van Etten-Jamaludin FS, Di Lorenzo C, Benninga MA, Tabbers MM. Prevalence of Functional Defecation Disorders in Children: A Systematic Review and Meta-Analysis. J Pediatr. 2018 Jul;198:121-130.e6. doi: 10.1016/j.jpeds.2018.02.029. Epub 2018 Apr 12.

    PubMed 29656863

  • Benninga MA, Faure C, Hyman PE, St James Roberts I, Schechter NL, Nurko S. Childhood Functional Gastrointestinal Disorders: Neonate/Toddler. Gastroenterology. 2016 Feb 15:S0016-5085(16)00182-7. doi: 10.1053/j.gastro.2016.02.016. Online ahead of print.

    PubMed 27144631

  • Hyams JS, Di Lorenzo C, Saps M, Shulman RJ, Staiano A, van Tilburg M. Functional Disorders: Children and Adolescents. Gastroenterology. 2016 Feb 15:S0016-5085(16)00181-5. doi: 10.1053/j.gastro.2016.02.015. Online ahead of print.

    PubMed 27144632

  • Tabbers MM, DiLorenzo C, Berger MY, Faure C, Langendam MW, Nurko S, Staiano A, Vandenplas Y, Benninga MA; European Society for Pediatric Gastroenterology, Hepatology, and Nutrition; North American Society for Pediatric Gastroenterology. Evaluation and treatment of functional constipation in infants and children: evidence-based recommendations from ESPGHAN and NASPGHAN. J Pediatr Gastroenterol Nutr. 2014 Feb;58(2):258-74. doi: 10.1097/MPG.0000000000000266.

    PubMed 24345831

  • Boilesen SN, Tahan S, Dias FC, Melli LCFL, de Morais MB. Water and fluid intake in the prevention and treatment of functional constipation in children and adolescents: is there evidence? J Pediatr (Rio J). 2017 Jul-Aug;93(4):320-327. doi: 10.1016/j.jped.2017.01.005. Epub 2017 Apr 25.

    PubMed 28450053

  • Santucci NR, Chogle A, Leiby A, Mascarenhas M, Borlack RE, Lee A, Perez M, Russell A, Yeh AM. Non-pharmacologic approach to pediatric constipation. Complement Ther Med. 2021 Jun;59:102711. doi: 10.1016/j.ctim.2021.102711. Epub 2021 Mar 15.

    PubMed 33737146

  • Koppen IJN, Saps M, Lavigne JV, Nurko S, Taminiau JAJM, Di Lorenzo C, Benninga MA. Recommendations for pharmacological clinical trials in children with functional constipation: The Rome foundation pediatric subcommittee on clinical trials. Neurogastroenterol Motil. 2018 Apr;30(4):e13294. doi: 10.1111/nmo.13294. Epub 2018 Jan 30.

    PubMed 29380480

Questions about this trial

What is this clinical trial studying?

A study testing Educational information in people with Constipation - Functional, run by Medical University of Warsaw.

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 1 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

Results are not available in the source record.

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

Contact Piotr Dziechciarz, MD PhD (+48223179539, piotr.dziechciarz@wum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants who no longer fulfill the Rome IV constipation criteria (time frame: last week of intervention). 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 NCT05191810, which also lists 7 linked publications.

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 3 Mar 2022.

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