Chronic Functional Constipation
Conditions
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.
Interventions
DEVICEmicro-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.
DRUGMacrogol 4000
Stool softener
Sponsors
Eclisse - Euromed Clinical Supply Services Srl
Ceinge - Biotecnologie Avanzate s.c. a r.l.
Latis S.r.l.
PhAST Consulting Srl
Aboca Spa Societa' Agricola
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized between two treatment arms
Eligibility
Sex/Gender
ALL
Age
6 Months to 48 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Product Safety | day 14, day 21 and day 56 | Adverse events reported by parents/legal representative of the subject |
| 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 |
| 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 | — |
Countries
Italy
Outcome results
None listed