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

Phase 4

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
micro-enema with Promelaxin	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
Macrogol 4000	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).

Primary Outcome Measures

Name	Time	Method
Improvement of constipation evaluated as a reduction of the typical symptoms of chronic functional constipation	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 Outcome Measures

Name	Time	Method
changes in the intestinal microbioma on day 21 and 56	day 21 and day 56	the intestinal microbioma will be analysed in laboratory to see whether a treatment influence can be measured
score of the parents quality of life calculated on day 21 and 56	day 21 and day 56	parents quality of life questionnaire
score of the children quality of life calculated on day 21 and 56	day 21 and day 56	children quality of life questionnaire
Gastrointestinal symptoms in children on days 14, 21 and 56	day 14, day 21 and day 56	gastrointestinal symptoms recording through/following treatment
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
Change in stool consistency	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
Product Safety	day 14, day 21 and day 56	Adverse events reported by parents/legal representative of the subject

Locations (4): ASL 1 Avezzano Sulmona L'Aquila - Ospedale San Salvatore - UO Clinica Pediatrica - Località Coppito
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L'Aquila, AQ, Italy
Fondazione IRCCS Policlinico San Matteo di Pavia- Dipartimento Scienze Clinico-Chirurgiche, Diagnostiche e Pediatriche - Viale Golgi, 19
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Pavia, PV, Italy
Dipartimento di Scienze Mediche Traslazionali - Pediatria - Università Federico II
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Napoli, Italy
AOU Università degli Studi della Campania "Luigi Vanvitelli"
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Napoli, Italy