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Completed

NCT Number: NCT02751411

Effectiveness & Safety of Promelaxin® Microenemas Against Macrogol 4000 P.O. in Chronic Constipation in Children 6-48 Months

The study is aimed at the efficacy and safety evalutation of the study treatments through a 2-weeks study period and the subsequent follow-up-

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Key information

Conditions

Chronic Functional Constipation

Age range

6 month–48 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

ASL 1 Avezzano Sulmona L'Aquila - Ospedale San Salvatore - UO Clinica Pediatrica - Località Coppito, L’Aquila, AQ, Italy

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About this study

This multicenter, prospective, randomized, controlled trial will be conducted on 120 infants-children with a diagnosis of chronic functional constipation according to the definition of Criteria of Rome III. The enrolled subjects will be randomized according to an electronically generated randomization list in 2 groups: one group will receive micro-enemas of Promelaxin® (Group A) while the second group will receive Macrogol 4000 per os (Group B) . Children will receive the dedicated treatment for two weeks and then undergo a follow-up period of a maximun of 6 weeks.

The hypothesis is that the protective micro-enema will help achieving regular evacuation by its local antinflammatory non-pharmacological action. This hypothesis is based on the finding that local anal inflammation can cause functional constipation due to discomfort and pain during evacuation or by influencing reflexes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic functional constipation according to Rome III criteria
  • No stool softeners therapy administered during the 7 days prior to Baseline Visit
  • Signature of informed consent from by both parents or legal representative
  • Willingness to follow the study schedule

Exclusion criteria

  • Suspicious or established diagnosis of organic constipation
  • Delayed emission of meconium in the term newborn
  • Presence of severe inflammatory bowel disease (such as ulcerative colitis, Crohn's disease), toxic megacolon
  • Presence/Risk of gastroinstestinal perforation
  • Presence/Suspiceous intestinal obstruction of symptomatic stenosis
  • (Undeterminated) Abdominal pain
  • Hypersensitivity to macrogol (polyethylene glycol) or to one or more product excipients
  • Hereditary fructose intolerance
  • Known hypersensitivity or allergy to any Promelaxin component
  • Presence of any other medical condition that contraindicate the use of Promelaxin® or Macrogol 4000

Treatment and study plan

micro-enema with Promelaxin

Device

The intervention has a lubricating, protective action on the anus and rectum and a balanced osmotic action which elicits the evacuation reflex.

Other names: Melilax

Macrogol 4000

Drug

Stool softener

Other names: Paxabel

Primary outcomes

  1. Improvement of constipation evaluated as a reduction of the typical symptoms of chronic functional constipation

    Time frame: day 14

    Treatment should be considered as successful if the child will show, at Visit 3, 3 or more defecations per week associated with an increase of 1 or more defecations versus baseline.

Secondary outcomes

  1. score of the parents quality of life calculated on day 21 and 56

    Time frame: day 21 and day 56

    parents quality of life questionnaire

  2. score of the children quality of life calculated on day 21 and 56

    Time frame: day 21 and day 56

    children quality of life questionnaire

  3. Gastrointestinal symptoms in children on days 14, 21 and 56

    Time frame: day 14, day 21 and day 56

    gastrointestinal symptoms recording through/following treatment

  4. changes in the intestinal microbioma on day 21 and 56

    Time frame: day 21 and day 56

    the intestinal microbioma will be analysed in laboratory to see whether a treatment influence can be measured

  5. Evaluation of the normalization of intestinal activity measured by recording frequency of evacuations and stool consistency on day 14, 21 and 56

    Time frame: day 14, day 21 and day 56

  6. Product Safety

    Time frame: day 14, day 21 and day 56

    Adverse events reported by parents/legal representative of the subject

  7. Change in stool consistency

    Time frame: day 14, day 21 and day 56

    Reduction of stool consistency with increase of 1 or more points on Bristol Stool Form Scale or Amsterdam scale

Sponsors and collaborators

Lead sponsor

Aboca Spa Societa' Agricola

Industry

Collaborators

  • Ceinge - Biotecnologie Avanzate s.c. a r.l.
  • Eclisse - Euromed Clinical Supply Services Srl
  • Latis S.r.l.
  • PhAST Consulting Srl

Registry information

Official study title

Multicenter, Prospective, Comparative, Randomized Controlled Clinical Trial to Evaluate the Performance and the Safety of Promelaxin® Micro-enemas Vs. Macrogol 4000 Per os in the Treatment of Functional Chronic Constipation in Children Aged Between 6 and 48 Months.

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Apr 26, 2016
Registry last updated
May 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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