Original article—alimentary tractOral Diosmectite Reduces Stool Output and Diarrhea Duration in Children With Acute Watery Diarrhea
Section snippets
Subjects
The Peru and Malaysia studies included children with acute watery diarrhea, in primary care hospitals.
According to previous studies it was expected that the decrease of total 72-hour stool output would be 30 g/kg of bodyweight with active drug compared with placebo, with a common standard deviation (SD) of 80 g/kg. For rejection of a 2-sided null hypothesis with a type I error of 5% and a type II error of 20%, at least 112 patients had to be included per group. We decided to include 300
Study populations
Three hundred patients were included in the intent-to-treat population (153 in the placebo group and 147 in the diosmectite group) between June 23, 2006, and February 1, 2007, in 11 primary care hospitals located in Lima (n = 9), Huacho (n = 1), and Ica (n = 1). Seventy-eight major deviations to the protocol were observed in 40 patients: 5 inclusion criteria were not respected, 39 patients were hospitalized for fewer than 70 hours, and 34 had treatment exposure for less than 48 hours. The
Discussion
The present studies show that diosmectite, used as an adjunct therapy to the ORS currently recommended by the World Health Organization,4 decreased 72-hour stool output in children, particularly if rotavirus-positive, and shortened the duration of acute watery diarrhea.
This study shows a significant effect of diosmectite on stool output, studied as a primary outcome, and diarrhea duration.7, 10, 11, 12, 13, 14, 21 In a previous study, Madkour et al13 showed that diosmectite shortens diarrhea
Acknowledgments
The authors are grateful to the nurses and study monitors who greatly helped with the patients in the study, to the Clinical Research Center (CRC), Kuala Lumpur Hospital, for monitoring in Malaysia, to Dr Elisabeth Leger-Picherit who performed the statistical analysis, and to Dr Guillaume Hébert from SC Partners who assisted in preparing the manuscript.
The Peru Diosmectite Study Group: Dante Figueroa Quintanilla, Pablo Huamaní Echeccaya: Instituto Especializado de Salud del Niño, Lima, Peru;
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Conflicts of interest Hélène Mathiex-Fortunet and Philippe Garnier are Ipsen employees.
Christophe Dupont, Jimmy Lee Kok Foo, Nicholas Moore, and Eduardo Salazar-Lindo have received honoraria and/or compensation in regards to the study, as an investigator, coordinator, or expert, in relation with the time spent on the study. The authors declare no conflict of interest in regards to the present article derived from the study, for which no compensation or stipend was received. There is no organic or regular relationship between the authors and Ipsen. The authors own no shares in Ipsen and no member of their immediate family is employed by Ipsen. Guillaume Hébert, from SC Partners, assisted in preparing the manuscript, according to a contract between Ipsen and SC Partners. The sponsor participated in study design, choice and set-up of centers, training for standardized stool collection, providing of materials (scales, diapers, World Health Organization oral rehydration solution), data monitoring, data collection, and preparation of the clinical study report.
Funding This study was supported by Ipsen, France, the developer of diosmectite and the owner of Smecta.