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Dried Plums (Prunes) vs. Polyethylene Glycol 4000 for Treatment of Functional Constipation in Children

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ClinicalTrials.gov Identifier: NCT03639142
Recruitment Status : Not yet recruiting
First Posted : August 20, 2018
Last Update Posted : August 20, 2018
Sponsor:
Information provided by (Responsible Party):
Piotr Dziechciarz, MD, Medical University of Warsaw

Brief Summary:
Children with functional constipation according to the Rome IV criteria will be randomly assigned to receive prunes at dose 3.5 g/kg/d (prune group) or Polyethylene Glycol 4000 (PEG group) at dose 0.5 g/kg/d for 4 weeks. Before treatment children with impaction will receive PEG 4000 at the dose 1.5 g/kg for 3-5 consecutive days. The primary outcome measure will be treatment success, defined as ≥3 BM per week with no fecal soiling during last week of the intervention.

Condition or disease Intervention/treatment Phase
Functional Constipation Other: Prunus domestica Drug: Polyethylene Glycol 4000 Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dried Plums (Prunes) vs. Polyethylene Glycol 4000 for Treatment of Functional Constipation in Children - Randomised Controlled Trial
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : November 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
Experimental: Plum group
Children will receive plums at dose 3,5g/kg/d as an oral treatment for constipation.
Other: Prunus domestica
Patients will receive prunes at dose 3,5 g/kg/d (max.100mg/day) in three portions a day, for 4 weeks (amount of prescribed prunes will be calibrated with the weight that child ought to have on WHO growth charts at 50th percentile). Prunes should be introduced every day in three meals. Prunes can be chopped or grinded before eating them. They can be eaten alone or child may eat them as a part of bigger meal (which is preferred version). Prunes can be introduced with yogurt, cereals, nuts and seeds as a morning meal.

Active Comparator: Polyethylene glycol group
Children will receive PEG at dose 0,5g/kg/d as an oral treatment for constipation.
Drug: Polyethylene Glycol 4000
Patients will receive PEG at dose 0,5 g/kg/d once daily orally, for 4 weeks.




Primary Outcome Measures :
  1. The primary outcome measure will be treatment success [ Time Frame: up to 4 weeks ]
    ≥3 spontaneous stools per week, without episodes of fecal soiling (in toilet-trained children), in the last week of the intervention (week 4).


Secondary Outcome Measures :
  1. stool consistency (according to the Bristol Stool Form Scale) during whole study period [ Time Frame: up to 4 weeks ]
  2. frequency of defecation per week [ Time Frame: up to 4 weeks ]
  3. frequency of fecal soiling per week [ Time Frame: up to 4 weeks ]
  4. frequency of pain during defecation per week [ Time Frame: up to 4 weeks ]
  5. frequency of abdominal pain or flatulence per week [ Time Frame: up to 4 weeks ]
  6. need for intake of additional laxative treatment during whole study period [ Time Frame: up to 4 weeks ]
  7. adverse events [ Time Frame: up to 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children with constipation diagnosed with ROME IV criteria

Exclusion Criteria:

  • diagnosis of irritable bowel syndrome, mental retardation, endocrine disease (eg, Hyperthyroidism), an organic cause of defecation disorders (eg, Hirshsprung disease, spinal anomalies, anorectal pathology, a history of gastrointestinal surgery), functional nonretentive fecal incontinence, or intake of medications influencing gastrointestinal motility

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): NCT03639142


Contacts
Contact: Krzysztof Zakościelny +48 507137840 krzysztof_zakoscielny@yahoo.com
Contact: Piotr Dziechciarz\ +48 501493839 piotrdz@hotmail.com

Sponsors and Collaborators
Medical University of Warsaw

Publications:

Responsible Party: Piotr Dziechciarz, MD, Principal Investigator, Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT03639142     History of Changes
Other Study ID Numbers: 1/2018
First Posted: August 20, 2018    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Piotr Dziechciarz, MD, Medical University of Warsaw:
constipation, prunes, children

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms