NCT03177434

Brief Summary

Assessment of efficacy of Dicopeg Junior, compared to lactulose, in the treatment of functional constipation in children aged 6 months to 6 years. The basis of assessment is to compare the number of commissioned stools (more than three stools per week) and stool consistency according to the scale of Bristol, in children taking Dicopeg Junior and children treated with lactulose. Childrens who meet the inclusion criteria will be randomized to one of two groups, in which the treatment will be as follows for 12 weeks:

  • weight up to 8 kg - 1 sachet per day
  • weight 8 - 12 kg - 2 sachets a day
  • weight 12 - 20 kg - 3 sachets a day
  • weight\> 20 kg - 4 sachets per day,
  • The second group - Lactulose at 2 ml / kg / day (in two doses). Preparations: Dicopeg Junior and Lactulose will be administered orally for the duration of the study (12 weeks).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2016

Typical duration for phase_4

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2016

Completed
1 year until next milestone

First Posted

Study publicly available on registry

June 6, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

June 6, 2017

Status Verified

June 1, 2017

Enrollment Period

2.2 years

First QC Date

June 2, 2016

Last Update Submit

June 4, 2017

Conditions

Constipation

Keywords

constipationchildrenpolyethylene glycols (PEG)lactulose

Outcome Measures

Primary Outcomes (1)

  • Assessment of efficacy of Dicopeg Junior, compared to lactulose, in the treatment of functional constipation in children aged 6 months to 6 years.

    The basis of assessment is to compare the number of commissioned stools (more than three stools per week) and stool consistency according to the scale of Bristol, in children taking Dicopeg Junior and children treated with lactulose.

    16 weeks

Study Arms (2)

Dicopeg Junior

ACTIVE COMPARATOR

Polyethylene glycols (PEG) - 3350 Dosage form: oral solution sachets Frequency: 2 doses Dosage: * weight up to 8 kg - 1 sachet per day * weight 8 - 12 kg - 2 sachets a day * weight 12 - 20 kg - 3 sachets a day * weight\> 20 kg - 4 sachets per day, Duration: 12 weeks vs Lactulose Dosage form: oral solution Dosage: 2 ml / kg / day Frequency: 2 doses Duration: 12 weeks

Drug: polyethylene glycols (PEG) 3350

Lactulose

ACTIVE COMPARATOR

Lactulose Dosage form: oral solution Dosage: 2 ml / kg / day Frequency: 2 doses Duration: 12 weeks

Drug: Lactulose Oral Product

Interventions

polyethylene glycols (PEG) 3350DRUG

Evaluating the efficacy of Dicopeg Junior in comparison with lactulose for the treatment of functional constipation in children aged 6 months to 6 years.

Dicopeg Junior
Lactulose Oral ProductDRUG

Evaluating the efficacy of Dicopeg Junior in comparison with lactulose for the treatment of functional constipation in children aged 6 months to 6 years.

Lactulose

Eligibility Criteria

Age6 Months - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 6 months - 6 years
  • Diagnosis of functional constipation according to the Rome III criteria
  • Patients newly recognized or ineffectively treated
  • Parental consent for their child's participation in the study and the way they are treatment for the duration of the study

You may not qualify if:

  • Well-known organic cause constipation (eg. an underactive thyroid, Hirschprung disease, cystic fibrosis).
  • Anatomical abnormality of the digestive tract.
  • Status after gastrointestinal surgery
  • Parents disagree to participate in the study
  • Intolerance of lactulose or polyethylene glycols in an interview
  • Comorbidities that may significantly affect the treatment outcome: food allergy, celiac disease, CNS disease, lactose intolerance or other disaccharide bacterial overgrowth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of Pediatrics, Gastroenterology and Allergology; Medical University of Bialystok

Bialystok, 15274, Poland

RECRUITING

University of Rzeszow

Rzeszów, 35959, Poland

RECRUITING

Department of Gastroenterology, Hepatology, Feeding Disorders and Pediatrics; The Childrens Memorial Health Institute

Warsaw, 04-730, Poland

RECRUITING

Related Publications (5)

  • 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.

    PMID: 24345831BACKGROUND

  • van den Berg MM, Benninga MA, Di Lorenzo C. Epidemiology of childhood constipation: a systematic review. Am J Gastroenterol. 2006 Oct;101(10):2401-9. doi: 10.1111/j.1572-0241.2006.00771.x.

    PMID: 17032205BACKGROUND

  • Rasquin A, Di Lorenzo C, Forbes D, Guiraldes E, Hyams JS, Staiano A, Walker LS. Childhood functional gastrointestinal disorders: child/adolescent. Gastroenterology. 2006 Apr;130(5):1527-37. doi: 10.1053/j.gastro.2005.08.063.

    PMID: 16678566BACKGROUND

  • Voskuijl W, de Lorijn F, Verwijs W, Hogeman P, Heijmans J, Makel W, Taminiau J, Benninga M. PEG 3350 (Transipeg) versus lactulose in the treatment of childhood functional constipation: a double blind, randomised, controlled, multicentre trial. Gut. 2004 Nov;53(11):1590-4. doi: 10.1136/gut.2004.043620.

    PMID: 15479678BACKGROUND

  • Jarzebicka D, Sieczkowska-Golub J, Kierkus J, Czubkowski P, Kowalczuk-Kryston M, Pelc M, Lebensztejn D, Korczowski B, Socha P, Oracz G. PEG 3350 Versus Lactulose for Treatment of Functional Constipation in Children: Randomized Study. J Pediatr Gastroenterol Nutr. 2019 Mar;68(3):318-324. doi: 10.1097/MPG.0000000000002192.

    PMID: 30383579DERIVED

MeSH Terms

Conditions

Constipation

Interventions

Polyethylene Glycols

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethylene GlycolsGlycolsAlcoholsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Central Study Contacts

Grzegorz Oracz, MD, Ph.D.

CONTACT

+48609840545agoracz@wp.pl

Jaroslaw Kierkus, MD, Ph.D.

CONTACT

+48500111648j.kierkus@ipczd.pl

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Prof.

Study Record Dates

First Submitted

June 2, 2016

First Posted

June 6, 2017

Study Start

February 1, 2016

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

June 6, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will share

publication

Locations

PL(3)