Research Article
Volume 9 Issue 4 - 2020
Efficacy and Safety of Straw Containing Probiotic (Bacillus coagulans) and Sennoside in Children Aged 5 to 12 Years Affected by Functional Constipation: A Pilot Study
Vikas D Gorad*
Om Sai Clinic, Nerul, Navi Mumbai, Maharashtra, India
*Corresponding Author: Vikas D Gorad, Om Sai Clinic, Nerul, Navi Mumbai, Maharashtra, India.
Received: March 02, 2020; Published: March 17, 2020


Background: We conducted an open-label, prospective pilot study to evaluate the efficacy and safety of straw containing Probiotic (Bacillus coagulans) and Sennoside in children aged 5 to 12 years affected by functional constipation (FC).

Materials and Methods: A total of 15 children aged 5 - 12 years affected by FC were administered M Sip Lax™ straw (sennoside 7.5 mg; Bacillus coagulans 1 billion colony-forming units (CFU); black salt 13 mg) once a day for three consecutive days. Efficacy and safety assessments were carried out at three follow-up visits: Visit 1 (Day 0, screening and enrollment), Visit 2 (Day 3+1, after three-day treatment with M Sip Lax™ straw), and Visit 3 (Day 6 or 7 after discontinuation of treatment). All patients were evaluated for baseline assessment, ROME III criteria, Bristol Stool Grading, Visual Analog Scale (VAS) score, total overall clinical condition, and investigators’ and patients’ assessment of the efficacy of treatment. Safety assessments included the incidence of adverse events, changes in vital statistics, and tolerability of the drug.

Results: A significant improvement was seen in ROME III criteria, Bristol Stool Grading, VAS score, and the total overall clinical condition of the subjects from baseline to Visit 2 (p < 0.05). The drug was well tolerated with no adverse events or treatment discontinuation.

Conclusion: The findings of the pilot study indicate that M Sip Lax™ straw containing probiotic B. coagulans and stimulant laxative senna may be considered a natural, novel, well-accepted, safe, and effective initial treatment strategy for functional constipation in children.

Keywords: Open -Label; Prospective; Efficacy; Safety; Probiotic; Sennoside


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Citation: Vikas D Gorad. “Efficacy and Safety of Straw Containing Probiotic (Bacillus coagulans) and Sennoside in Children Aged 5 to 12 Years Affected by Functional Constipation: A Pilot Study”. EC Paediatrics 9.4 (2020): 66-79.

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