Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of Dicopeg Junior in Comparison With Lactulose for the Treatment of Functional Constipation in Children Aged 6 Months to 6 Years.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03177434
Recruitment Status : Unknown
Verified June 2017 by JAROSLAW KIERKUS, Children's Memorial Health Institute, Poland.
Recruitment status was:  Recruiting
First Posted : June 6, 2017
Last Update Posted : June 6, 2017
Sponsor:
Collaborators:
Medical University of Bialystok
University of Rzeszow
Information provided by (Responsible Party):
JAROSLAW KIERKUS, Children's Memorial Health Institute, Poland

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:

  1. The first group - Dicopeg Junior (max. in 2 doses) in a dose of:

    • 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,
  2. 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).

Condition or disease Intervention/treatment Phase
Constipation Drug: polyethylene glycols (PEG) 3350 Drug: Lactulose Oral Product Phase 4

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Multicenter Study Evaluating the Efficacy of Dicopeg Junior in Comparison With Lactulose for the Treatment of Functional Constipation in Children Aged 6 Months to 6 Years. A Prospective, Randomized Study.
Study Start Date : February 2016
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
Active Comparator: Dicopeg Junior

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

Active Comparator: Lactulose
Lactulose Dosage form: oral solution Dosage: 2 ml / kg / day Frequency: 2 doses Duration: 12 weeks
Drug: Lactulose Oral Product
Evaluating the efficacy of Dicopeg Junior in comparison with lactulose for the treatment of functional constipation in children aged 6 months to 6 years.




Primary Outcome Measures :
  1. Assessment of efficacy of Dicopeg Junior, compared to lactulose, in the treatment of functional constipation in children aged 6 months to 6 years. [ Time Frame: 16 weeks ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03177434


Contacts
Layout table for location contacts
Contact: Grzegorz Oracz, MD, Ph.D. +48609840545 agoracz@wp.pl
Contact: Jaroslaw Kierkus, MD, Ph.D. +48500111648 j.kierkus@ipczd.pl

Locations
Layout table for location information
Poland
Department of Pediatrics, Gastroenterology and Allergology; Medical University of Bialystok Recruiting
Bialystok, Poland, 15274
Contact: Dariusz Lebensztejn, MD, PhD    +48 857422271    pegaz@umb.edu.pl   
University of Rzeszow Recruiting
Rzeszow, Poland, 35959
Contact: Bartosz Korczowski    + 48 17 872 10 00    korczpwski@op.pl   
Department of Gastroenterology, Hepatology, Feeding Disorders and Pediatrics; The Childrens Memorial Health Institute Recruiting
Warsaw, Poland, 04-730
Contact: Jaroslaw Kierkus    +48 22 815 73 84    j.kierkus@czd.pl   
Sub-Investigator: Jaroslaw Kierkus, MD, PhD         
Principal Investigator: Grzegorz Oracz, MD, PhD         
Sub-Investigator: Dorota Jarzebicka, MD         
Sub-Investigator: Joanna Sieczkowska, MD         
Sponsors and Collaborators
Children's Memorial Health Institute, Poland
Medical University of Bialystok
University of Rzeszow

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: JAROSLAW KIERKUS, Ass. Prof., Children's Memorial Health Institute, Poland
ClinicalTrials.gov Identifier: NCT03177434    
Other Study ID Numbers: IPCZD 27.01.2016
First Posted: June 6, 2017    Key Record Dates
Last Update Posted: June 6, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: publication
Keywords provided by JAROSLAW KIERKUS, Children's Memorial Health Institute, Poland:
constipation
children
polyethylene glycols (PEG)
lactulose
Additional relevant MeSH terms:
Layout table for MeSH terms
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Lactulose
Gastrointestinal Agents