An open label, non-comparative pilot study to assess the efficacy and safety of a food supplement containing manna in pediatric functional constipation

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Mihai Gafencu
Dionisio Franco Barattini
Serban Rosu
Andrea Martina Clemente
Marius Ardelean
Filippo Murina

Keywords

children, functional constipation, manna, food supplement, fiber.

Abstract

Objective. The primary objective of this study was to evaluate the efficacy and safety of the food supplement Physiomanna Baby® in pediatric patients with a history of functional constipation defined by Rome III criteria; secondary objective was to evaluate the adherence to the tested product in the enrolled children. Methods. The trial was designed as an open label, non-comparative pilot trial. In 3 Romanian sites (one community hospital and two private medical practice offices) 49 children (20 males, 29 females) aged 0 - 8 years were enrolled. The study was conducted between February 2016 and April 2016. The investigational product was administered as 1 g/kg in single daily oral administration from the first day and continued for a maximum of 3 days in the first week. If the constipation symptoms persisted, the children were treated in an additional cycle of treatment for a maximum of 3 days. Results. The number of Spontaneous Bowel Movements (SBM) per week has increased to normal after Physiomanna Baby® administration (from 1.80 ± 0.41 at baseline to 6.04±1.54 at day 8) evidencing a statistically significant difference (P-value <0.0001). The efficacy was also demonstrated in the subpopulation of children <4 years where the mean values per week increased from 1.69±0.47 at baseline to 6.15±1.59 SBM at day 8 (P-value <0.0001). According to Investigator Global Assessment of Efficacy (IGAE), Physiomanna Baby® shows immediate and excellent efficacy after one or two doses for 79.60% of the children, a very good efficacy after three doses for 12.24% and good efficacy after the second cycle of administration for 6.12% of children. Both Investigator Global Assessment for Safety (IGAS) and Patient Global Assessment for Safety (PGAS) were rated as 100% excellent for all patients. Conclusions. The food supplement Physiomanna Baby® provided immediate efficacy, offering to pediatricians a safe solution in the care of mild to moderate functional constipation, even if the study design characteristics were limited (pilot trial with a small sample size and without control group).

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