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

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.

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-

Study Overview

• Status: Completed
• Conditions: Chronic Functional Constipation
• Intervention / Treatment: Device: micro-enema with Promelaxin; Drug: Macrogol 4000

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 158
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Napoli, Italy, 80131
    • Dipartimento di Scienze Mediche Traslazionali - Pediatria - Università Federico II
  • Napoli, Italy, 80138
    • AOU Università degli Studi della Campania "Luigi Vanvitelli"
  • AQ
    • L'Aquila, AQ, Italy, 67100
      • ASL 1 Avezzano Sulmona L'Aquila - Ospedale San Salvatore - UO Clinica Pediatrica - Località Coppito
  • PV
    • Pavia, PV, Italy, 27100
      • Fondazione IRCCS Policlinico San Matteo di Pavia- Dipartimento Scienze Clinico-Chirurgiche, Diagnostiche e Pediatriche - Viale Golgi, 19

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: micro-enema with Promelaxin; 2,5 g, 5 g or 2X5 g (calculated considering patient age) have to be administered daily (in the evening) for one week, once every other day for the second week and as needed for the following 6 weeks	Device: micro-enema with Promelaxin; 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
Active Comparator: Macrogol 4000; One/Two sachets of the study treatment has to be solubilized in 50mL of water and then administered daily. The administration should take place in the morning (the first sachet or in the event that only one sachet/day should be administered) and in the evening (second sachet).	Drug: Macrogol 4000; Stool softener; Other Names: Paxabel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of constipation evaluated as a reduction of the typical symptoms of chronic functional constipation	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.	day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
score of the parents quality of life calculated on day 21 and 56	parents quality of life questionnaire	day 21 and day 56
score of the children quality of life calculated on day 21 and 56	children quality of life questionnaire	day 21 and day 56
Gastrointestinal symptoms in children on days 14, 21 and 56	gastrointestinal symptoms recording through/following treatment	day 14, day 21 and day 56
changes in the intestinal microbioma on day 21 and 56	the intestinal microbioma will be analysed in laboratory to see whether a treatment influence can be measured	day 21 and day 56
Evaluation of the normalization of intestinal activity measured by recording frequency of evacuations and stool consistency on day 14, 21 and 56		day 14, day 21 and day 56
Product Safety	Adverse events reported by parents/legal representative of the subject	day 14, day 21 and day 56
Change in stool consistency	Reduction of stool consistency with increase of 1 or more points on Bristol Stool Form Scale or Amsterdam scale	day 14, day 21 and day 56

Collaborators and Investigators

• Sponsor: Aboca Spa Societa' Agricola
• Collaborators: Latis S.r.l.; Eclisse - Euromed Clinical Supply Services Srl; Ceinge - Biotecnologie Avanzate s.c. a r.l.; PhAST Consulting Srl
• Investigators: Principal Investigator: Annamaria Staiano, Prof., Universita Federico II - Pediatric Department

Publications and helpful links

General Publications

• Strisciuglio C, Coppola V, Russo M, Tolone C, Marseglia GL, Verrotti A, Caimmi S, Caloisi C, D'Argenio V, Sacchetti L, Staiano A. Promelaxin Microenemas Are Non-inferior to Oral Polyethylene Glycol for the Treatment of Functional Constipation in Young Children: A Randomized Clinical Trial. Front Pediatr. 2021 Oct 29;9:753938. doi: 10.3389/fped.2021.753938. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2016
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): March 17, 2020

Study Registration Dates

• First Submitted: April 22, 2016
• First Submitted That Met QC Criteria: April 22, 2016
• First Posted (Estimate): April 26, 2016

Study Record Updates

• Last Update Posted (Actual): May 29, 2020
• Last Update Submitted That Met QC Criteria: May 28, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: ABO-MELI-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No