NCT03639142

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2018

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

First Submitted

Initial submission to the registry

August 14, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 20, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

August 23, 2018

Status Verified

August 1, 2018

Enrollment Period

2 years

First QC Date

August 14, 2018

Last Update Submit

August 21, 2018

Conditions

Functional Constipation

Keywords

constipation, prunes, children

Outcome Measures

Primary Outcomes (1)

  • The primary outcome measure will be treatment success

    ≥3 spontaneous stools per week, without episodes of fecal soiling (in toilet-trained children), in the last week of the intervention (week 4).

    up to 4 weeks

Secondary Outcomes (7)

  • stool consistency (according to the Bristol Stool Form Scale) during whole study period

    up to 4 weeks

  • frequency of defecation per week

    up to 4 weeks

  • frequency of fecal soiling per week

    up to 4 weeks

  • frequency of pain during defecation per week

    up to 4 weeks

  • frequency of abdominal pain or flatulence per week

    up to 4 weeks

  • +2 more secondary outcomes

Study Arms (2)

Plum group

EXPERIMENTAL

Children will receive plums at dose 3,5g/kg/d as an oral treatment for constipation.

Other: Prunus domestica

Polyethylene glycol group

ACTIVE COMPARATOR

Children will receive PEG at dose 0,5g/kg/d as an oral treatment for constipation.

Drug: Polyethylene Glycol 4000

Interventions

Prunus domesticaOTHER

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.

Plum group
Polyethylene Glycol 4000DRUG

Patients will receive PEG at dose 0,5 g/kg/d once daily orally, for 4 weeks.

Polyethylene glycol group

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • children with constipation diagnosed with ROME IV criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • Attaluri A, Donahoe R, Valestin J, Brown K, Rao SS. Randomised clinical trial: dried plums (prunes) vs. psyllium for constipation. Aliment Pharmacol Ther. 2011 Apr;33(7):822-8. doi: 10.1111/j.1365-2036.2011.04594.x. Epub 2011 Feb 15.

    PMID: 21323688BACKGROUND

  • 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.

    PMID: 27144631BACKGROUND

  • Chmielewska A, Horvath A, Dziechciarz P, Szajewska H. Glucomannan is not effective for the treatment of functional constipation in children: a double-blind, placebo-controlled, randomized trial. Clin Nutr. 2011 Aug;30(4):462-8. doi: 10.1016/j.clnu.2011.01.012. Epub 2011 Feb 12.

    PMID: 21320737BACKGROUND

  • Dehghani SM, Kulouee N, Honar N, Imanieh MH, Haghighat M, Javaherizadeh H. Clinical Manifestations among Children with Chronic Functional Constipation. Middle East J Dig Dis. 2015 Jan;7(1):31-5.

    PMID: 25628851BACKGROUND

  • Dziechciarz P, Horvath A, Szajewska H. Polyethylene glycol 4000 for treatment of functional constipation in children. J Pediatr Gastroenterol Nutr. 2015 Jan;60(1):65-8. doi: 10.1097/MPG.0000000000000543.

    PMID: 25162362BACKGROUND

  • Horvath A, Dziechciarz P, Szajewska H. Glucomannan for abdominal pain-related functional gastrointestinal disorders in children: a randomized trial. World J Gastroenterol. 2013 May 28;19(20):3062-8. doi: 10.3748/wjg.v19.i20.3062.

    PMID: 23716985BACKGROUND

  • Koppen IJ, Nurko S, Saps M, Di Lorenzo C, Benninga MA. The pediatric Rome IV criteria: what's new? Expert Rev Gastroenterol Hepatol. 2017 Mar;11(3):193-201. doi: 10.1080/17474124.2017.1282820. Epub 2017 Jan 24.

    PMID: 28092724BACKGROUND

  • Lever E, Cole J, Scott SM, Emery PW, Whelan K. Systematic review: the effect of prunes on gastrointestinal function. Aliment Pharmacol Ther. 2014 Oct;40(7):750-8. doi: 10.1111/apt.12913. Epub 2014 Aug 11.

    PMID: 25109788BACKGROUND

  • Mugie SM, Benninga MA, Di Lorenzo C. Epidemiology of constipation in children and adults: a systematic review. Best Pract Res Clin Gastroenterol. 2011 Feb;25(1):3-18. doi: 10.1016/j.bpg.2010.12.010.

    PMID: 21382575BACKGROUND

  • 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

  • Zeevenhooven J, Koppen IJ, Benninga MA. The New Rome IV Criteria for Functional Gastrointestinal Disorders in Infants and Toddlers. Pediatr Gastroenterol Hepatol Nutr. 2017 Mar;20(1):1-13. doi: 10.5223/pghn.2017.20.1.1. Epub 2017 Mar 27.

    PMID: 28401050BACKGROUND

MeSH Terms

Conditions

Constipation

Interventions

polyethylene glycol 4000

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Krzysztof Zakościelny

CONTACT

+48 507137840krzysztof_zakoscielny@yahoo.com

Piotr Dziechciarz\

CONTACT

+48 501493839piotrdz@hotmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 14, 2018

First Posted

August 20, 2018

Study Start

September 1, 2018

Primary Completion

September 1, 2020

Study Completion

November 1, 2020

Last Updated

August 23, 2018

Record last verified: 2018-08