Promelaxin Microenemas Are Non-inferior to Oral Polyethylene Glycol for the Treatment of Functional Constipation in Young Children: A Randomized Clinical Trial
Background: Polyethylene glycol (PEG) is recommended as first-line treatment of pediatric functional constipation. However, the oral route of administration is often poorly feasible in children mostly due to poor palatability. Promelaxin microenemas exert a topical evacuative action and may offer a...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2021-10-01
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| Series: | Frontiers in Pediatrics |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fped.2021.753938/full |
| _version_ | 1818925844789198848 |
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| author | Caterina Strisciuglio Vincenzo Coppola Marina Russo Carlo Tolone Gian Luigi Marseglia Alberto Verrotti Silvia Caimmi Claudia Caloisi Valeria D'Argenio Valeria D'Argenio Lucia Sacchetti Annamaria Staiano |
| author_facet | Caterina Strisciuglio Vincenzo Coppola Marina Russo Carlo Tolone Gian Luigi Marseglia Alberto Verrotti Silvia Caimmi Claudia Caloisi Valeria D'Argenio Valeria D'Argenio Lucia Sacchetti Annamaria Staiano |
| author_sort | Caterina Strisciuglio |
| collection | DOAJ |
| description | Background: Polyethylene glycol (PEG) is recommended as first-line treatment of pediatric functional constipation. However, the oral route of administration is often poorly feasible in children mostly due to poor palatability. Promelaxin microenemas exert a topical evacuative action and may offer a valuable option in pediatric FC.Aim: To assess whether Promelaxin microenemas would be non-inferior to PEG 4000 in young children with FC.Methods: This is a randomized, open-label, multi-centric, non-inferiority trial enrolling infants and young children aged 6–48 months, with FC according to Rome III criteria. After 1 week of run in, children were randomized to 2 weeks of Promelaxin or PEG, followed by a 6-week on-demand treatment period. Primary endpoint was response rate to randomized treatment, with “response” defined as at least 3 evacuations per week and an average increase of at least one evacuation per week as compared to baseline. Safety, stool consistency and the analysis of fecal microbiota were secondary endpoints.Results: Out of the 158 patients who entered the trial, 153 patients were treated (77 and 76, PEG and Promelaxin arm, respectively). In the primary analysis, the 95% confidence interval (CI) for the treatment's effect lay entirely above the non-inferiority margin in both Full Set (FAS) and Per Protocol (PP) analyses, providing evidence of the non-inferiority of Promelaxin vs. PEG 4000 [response rate difference: 16.5% (CI 1.55–31.49%) and 11.03% (CI −5.58 to 27.64%), FAS and PP analyses, respectively]. Mean compliance to the randomized treatment was >80% in both arms. Secondary endpoints did not significantly differ between the two arms, except for the average number of total days of on-demand treatment that was significantly lower in the Promelaxin arm [14.6 (12.7) vs. 9.8 (9.1), mean (SD); primary endpoint responders in PEG and Promelaxin arm, respectively; p = 0.027]. Microbiota evenness significantly increased in the PEG 4000 arm at V4 as compared to the Promelaxin arm (p < 0.05). In addition, at V5, patients treated with PEG showed a significantly decreased microbiota density as compared to patients treated with Promelaxin (p = 0.036).Conclusions: Promelaxin microenemas are non-inferior to oral PEG in children with FC.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT02751411. |
| first_indexed | 2024-12-20T02:47:41Z |
| format | Article |
| id | doaj.art-b6e9f2bba3824c43a0e5a9ed1baf139a |
| institution | Directory Open Access Journal |
| issn | 2296-2360 |
| language | English |
| last_indexed | 2024-12-20T02:47:41Z |
| publishDate | 2021-10-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pediatrics |
| spelling | doaj.art-b6e9f2bba3824c43a0e5a9ed1baf139a2022-12-21T19:56:07ZengFrontiers Media S.A.Frontiers in Pediatrics2296-23602021-10-01910.3389/fped.2021.753938753938Promelaxin Microenemas Are Non-inferior to Oral Polyethylene Glycol for the Treatment of Functional Constipation in Young Children: A Randomized Clinical TrialCaterina Strisciuglio0Vincenzo Coppola1Marina Russo2Carlo Tolone3Gian Luigi Marseglia4Alberto Verrotti5Silvia Caimmi6Claudia Caloisi7Valeria D'Argenio8Valeria D'Argenio9Lucia Sacchetti10Annamaria Staiano11Department of Woman, Child and General and Specialized Surgery, University of Campania “Luigi Vanvitelli”, Naples, ItalyDepartment of Translational Medical Sciences, Section of Pediatric, University of Naples Federico II, Naples, ItalyDepartment of Translational Medical Sciences, Section of Pediatric, University of Naples Federico II, Naples, ItalyDepartment of Woman, Child and General and Specialized Surgery, University of Campania “Luigi Vanvitelli”, Naples, ItalyMaternal and Child Department, IRCCS Foundation Policlinico “S. Matteo” di Pavia, Pavia, ItalyDepartment of Pediatrics, University of Perugia, Perugia, ItalyMaternal and Child Department, IRCCS Foundation Policlinico “S. Matteo” di Pavia, Pavia, ItalyDepartment of Pediatrics, University of L'Aquila, L'Aquila, ItalyCEINGE Biotecnologie Avanzate S. C. A R. L., Naples, ItalyDepartment of Human Sciences and Promotion of the Quality of Life, San Raffaele Open University, Rome, ItalyCEINGE Biotecnologie Avanzate S. C. A R. L., Naples, ItalyDepartment of Translational Medical Sciences, Section of Pediatric, University of Naples Federico II, Naples, ItalyBackground: Polyethylene glycol (PEG) is recommended as first-line treatment of pediatric functional constipation. However, the oral route of administration is often poorly feasible in children mostly due to poor palatability. Promelaxin microenemas exert a topical evacuative action and may offer a valuable option in pediatric FC.Aim: To assess whether Promelaxin microenemas would be non-inferior to PEG 4000 in young children with FC.Methods: This is a randomized, open-label, multi-centric, non-inferiority trial enrolling infants and young children aged 6–48 months, with FC according to Rome III criteria. After 1 week of run in, children were randomized to 2 weeks of Promelaxin or PEG, followed by a 6-week on-demand treatment period. Primary endpoint was response rate to randomized treatment, with “response” defined as at least 3 evacuations per week and an average increase of at least one evacuation per week as compared to baseline. Safety, stool consistency and the analysis of fecal microbiota were secondary endpoints.Results: Out of the 158 patients who entered the trial, 153 patients were treated (77 and 76, PEG and Promelaxin arm, respectively). In the primary analysis, the 95% confidence interval (CI) for the treatment's effect lay entirely above the non-inferiority margin in both Full Set (FAS) and Per Protocol (PP) analyses, providing evidence of the non-inferiority of Promelaxin vs. PEG 4000 [response rate difference: 16.5% (CI 1.55–31.49%) and 11.03% (CI −5.58 to 27.64%), FAS and PP analyses, respectively]. Mean compliance to the randomized treatment was >80% in both arms. Secondary endpoints did not significantly differ between the two arms, except for the average number of total days of on-demand treatment that was significantly lower in the Promelaxin arm [14.6 (12.7) vs. 9.8 (9.1), mean (SD); primary endpoint responders in PEG and Promelaxin arm, respectively; p = 0.027]. Microbiota evenness significantly increased in the PEG 4000 arm at V4 as compared to the Promelaxin arm (p < 0.05). In addition, at V5, patients treated with PEG showed a significantly decreased microbiota density as compared to patients treated with Promelaxin (p = 0.036).Conclusions: Promelaxin microenemas are non-inferior to oral PEG in children with FC.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT02751411.https://www.frontiersin.org/articles/10.3389/fped.2021.753938/fullpolyethylene glycolPromelaxin microenemasmedical devices based on substancesfunctional constipationyoung children |
| spellingShingle | Caterina Strisciuglio Vincenzo Coppola Marina Russo Carlo Tolone Gian Luigi Marseglia Alberto Verrotti Silvia Caimmi Claudia Caloisi Valeria D'Argenio Valeria D'Argenio Lucia Sacchetti Annamaria Staiano Promelaxin Microenemas Are Non-inferior to Oral Polyethylene Glycol for the Treatment of Functional Constipation in Young Children: A Randomized Clinical Trial Frontiers in Pediatrics polyethylene glycol Promelaxin microenemas medical devices based on substances functional constipation young children |
| title | Promelaxin Microenemas Are Non-inferior to Oral Polyethylene Glycol for the Treatment of Functional Constipation in Young Children: A Randomized Clinical Trial |
| title_full | Promelaxin Microenemas Are Non-inferior to Oral Polyethylene Glycol for the Treatment of Functional Constipation in Young Children: A Randomized Clinical Trial |
| title_fullStr | Promelaxin Microenemas Are Non-inferior to Oral Polyethylene Glycol for the Treatment of Functional Constipation in Young Children: A Randomized Clinical Trial |
| title_full_unstemmed | Promelaxin Microenemas Are Non-inferior to Oral Polyethylene Glycol for the Treatment of Functional Constipation in Young Children: A Randomized Clinical Trial |
| title_short | Promelaxin Microenemas Are Non-inferior to Oral Polyethylene Glycol for the Treatment of Functional Constipation in Young Children: A Randomized Clinical Trial |
| title_sort | promelaxin microenemas are non inferior to oral polyethylene glycol for the treatment of functional constipation in young children a randomized clinical trial |
| topic | polyethylene glycol Promelaxin microenemas medical devices based on substances functional constipation young children |
| url | https://www.frontiersin.org/articles/10.3389/fped.2021.753938/full |
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