Clinical trial NCT02751411: Effectiveness & Safety of Promelaxin® Microenemas Against Macrogol 4000 P.O. in Chronic Constipation in Children 6-48 Months
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Functional Constipation
Lead sponsor: Aboca Spa Societa' Agricola
Sponsor class: INDUSTRY
Collaborators: name: Eclisse - Euromed Clinical Supply Services Srl
name: Ceinge - Biotecnologie Avanzate s.c. a r.l.
name: Latis S.r.l.
name: PhAST Consulting Srl
First posted: 2016-04-26
Enrollment: 158
Sex: ALL
Minimum age (years): 6
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized between two treatment arms
Primary purpose: TREATMENT

Brief summary: 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-

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.

Eligibility criteria: 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

Primary outcomes:
measure: Improvement of constipation evaluated as a reduction of the typical symptoms of chronic functional constipation
timeFrame: day 14
Secondary outcomes:
measure: score of the parents quality of life calculated on day 21 and 56
timeFrame: day 21 and day 56
measure: score of the children quality of life calculated on day 21 and 56
timeFrame: day 21 and day 56
measure: Gastrointestinal symptoms in children on days 14, 21 and 56
timeFrame: day 14, day 21 and day 56
measure: changes in the intestinal microbioma on day 21 and 56
timeFrame: day 21 and day 56
measure: Evaluation of the normalization of intestinal activity measured by recording frequency of evacuations and stool consistency on day 14, 21 and 56
timeFrame: day 14, day 21 and day 56
measure: Product Safety
timeFrame: day 14, day 21 and day 56
measure: Change in stool consistency
timeFrame: day 14, day 21 and day 56
Other outcomes:
Locations:
city: L'Aquila
country: Italy
facility: ASL 1 Avezzano Sulmona L'Aquila - Ospedale San Salvatore - UO Clinica Pediatrica - Località Coppito
state: AQ
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo di Pavia- Dipartimento Scienze Clinico-Chirurgiche, Diagnostiche e Pediatriche - Viale Golgi, 19
state: PV
city: Napoli
country: Italy
facility: Dipartimento di Scienze Mediche Traslazionali - Pediatria - Università Federico II
city: Napoli
country: Italy
facility: AOU Università degli Studi della Campania "Luigi Vanvitelli"
Study officials:
affiliation: Universita Federico II - Pediatric Department
name: Annamaria Staiano, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.