Randomized, placebo-controlled trial of xyloglucan and gelose for the treatment of acute diarrhea in children

ABSTRACT

Background

Oral rehydration is the main treatment of acute diarrhea in children. This study was undertaken to evaluate the efficacy and safety of xyloglucan and gelose (agar-agar) plus oral rehydration solution (ORS) compared with placebo and ORS for reduction of acute diarrhea symptoms in children.

Methods

In a randomized, double-blind, placebo-controlled trial, children with acute gastroenteritis received xyloglucan/gelose plus ORS (n = 50) or placebo plus ORS (n = 50) for 5 days. Demographic, clinical, anthropometric and laboratory parameters were recorded and analyzed.

Results

Xyloglucan/gelose plus ORS reduced the total number of type 7 and 6 stools on the Bristol Stool Form scale (p = 0.040 and p = 0.015, respectively, compared to placebo plus ORS), and had a rapid onset of action, evident 6 hours post-treatment. Xyloglucan/gelose plus ORS also improved associated clinical symptoms (apathy, vomiting, flatulence, and blood in stool). compared with placebo plus ORS. Except for a generalized rash of unknown causality in a patient receiving placebo plus ORS, all other adverse events (dehydration, n = 7, cough, n = 1, exacerbation of vomiting, n = 1) were deemed unrelated to study medication.

Conclusions

Xyloglucan/gelose plus ORS was effective and safe in treating acute diarrhea in children.

KEYWORDS:

• Acute gastroenteritis
• acute diarrhea
• children
• oral rehydration solution
• xyloglucan
• gelose
• agar-agar

Acknowledgments

The author wishes to thank Cebis International (Lugano, Switzerland) for assistance with study design, data collection and statistical analysis. Editorial support was provided by Content Ed Net (Madrid, Spain), with funding from Noventure SL (Barcelona, Spain).

Declaration of interest

Javier Santos has equity in and consults for Devintec Pharma, Noventure SL, and Pileje SLU and receives grant support from MRM Health NV. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Contributions

Javier Santos: conception, design, acquisition of data, analysis and interpretation of data; drafting the work, revising it critically and final approval. Virgil Musta: conception, design, acquisition of data, analysis and interpretation of data; drafting the work, revising it critically and final approval. Catalina Mihaela Luca: conception, design, acquisition of data, analysis and interpretation of data; drafting the work, revising it critically and final approval.Oana Andreea Belei: conception, design, acquisition of data, analysis and interpretation of data; drafting the work, revising it critically and final approval. Simona Claudia Cambrea: conception, design, acquisition of data, analysis and interpretation of data; drafting the work, revising it critically and final approval.

Supplementary material

Supplemental data for this article can be accessed here.

Additional information

Funding

The study was sponsored by Noventure SL (Barcelona, Spain).