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| Name | Class |
|---|---|
| Eclisse - Euromed Clinical Supply Services Srl | UNKNOWN |
| Ceinge - Biotecnologie Avanzate s.c. a r.l. | UNKNOWN |
| Latis S.r.l. | INDUSTRY |
| PhAST Consulting Srl |
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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-
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| micro-enema with Promelaxin | Experimental | 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 | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Annamaria Staiano, Prof. | Universita Federico II - Pediatric Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASL 1 Avezzano Sulmona L'Aquila - Ospedale San Salvatore - UO Clinica Pediatrica - Località Coppito | L’Aquila | AQ | 67100 | Italy | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34778144 | Derived | 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. |
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| UNKNOWN |
Randomized between two treatment arms
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|
| Macrogol 4000 | Drug | Stool softener |
|
|
| 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 |
| Fondazione IRCCS Policlinico San Matteo di Pavia- Dipartimento Scienze Clinico-Chirurgiche, Diagnostiche e Pediatriche - Viale Golgi, 19 |
| Pavia |
| PV |
| 27100 |
| Italy |
| Dipartimento di Scienze Mediche Traslazionali - Pediatria - Università Federico II | Naples | 80131 | Italy |
| AOU Università degli Studi della Campania "Luigi Vanvitelli" | Naples | 80138 | Italy |
| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| ID | Term |
|---|---|
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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