Randomized trial to assess the efficacy and safety of xyloglucan for the treatment of acute gastroenteritis in children

Acute gastroenteritis is one of the most common diseases in children and an important cause of morbidity and mortality worldwide. No specific treatment is available; therefore, management is exclusively symptomatic. Xyloglucan has been approved in Europe as a class IIa medical device for restoration...

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Bibliographic Details
Published in:	Food science & nutrition Vol. 11; no. 12; pp. 7698 - 7706
Main Authors:	Perez‐Garcia, Maria Jose, Royuela, Ana, Rodriguez‐Contreras, Francisco‐Javier, PandoBravo, Maria Angeles, Chiatti, Cristina, Ramos, Carmen, Arana‐Zumaquero, Mario, Gonzalez‐Marcos, Maria Isabel, Diaz, Juncal, Fresno‐Calle, Maria Cristina, García‐Bartolomé, Ruth, Viver, Susana, Villaverde‐Gonzalez, Serena, Cilleruelo‐Pascual, Maria Luz, Gutierrez‐Junquera, Carolina, Rasines‐Rodriguez, Alejandro, Manso‐Pérez, Alba, Román‐Riechmann, Enriqueta
Format:	Journal Article
Language:	English
Published:	United States John Wiley & Sons, Inc 01-12-2023 John Wiley and Sons Inc
Subjects:	Antigens child Child mortality Children Childrens health Clinical trials Diarrhea Drug dosages Effectiveness Gastroenteritis Health services Informed consent Intervention Malnutrition Medical devices Morbidity Normality Original Parents & parenting Patients Pediatrics Placebos Population studies Primary care Probiotics randomized controlled trial Rehydration Rotavirus Safety Statistical analysis Variables Viruses Vomiting Weight loss Xyloglucan Spain gastroenteritis diarrhea xyloglucan child randomized controlled trial
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Summary:	Acute gastroenteritis is one of the most common diseases in children and an important cause of morbidity and mortality worldwide. No specific treatment is available; therefore, management is exclusively symptomatic. Xyloglucan has been approved in Europe as a class IIa medical device for restoration of the physiological functions of the intestinal wall. Our objective was to assess efficacy and safety of xyloglucan for the treatment of acute gastroenteritis in children. We performed a triple‐blind, randomized placebo‐controlled clinical trial in four primary care centers and one continued care hospital center. The study population comprised children with acute gastroenteritis aged >3 months and <5 years. Our primary endpoint was time (in hours) of resolution of diarrhea, defined as the time to resolution of stool consistency (Bristol Stool Form Scale ≤5 or Amsterdam Stool Form Scale B or C) or time until deposition frequency resumes to normality, whichever occurred first. We also recorded intravenous rehydration, hospitalization, stools per day, Vesikari scale, vomiting, relapse, weight loss, drugs prescribed, and adverse events. Eighty children were included in the intention‐to‐treat population (43 xyloglucan and 37 placebo) and 74 (93%) in the per‐protocol population. Time to resolution of diarrhea was similar in both groups with (median, 95% CI) 24, 17–24 h in the xyloglucan group versus 24, 19–24 h in the placebo group, p = .680. Significant differences were observed for patients with moderate‐to‐severe diarrhea (Vesikari scale ≥9): xyloglucan group (20 [15–24] h) versus placebo group (85 [51–120] h) (p = .04). No other significant differences were found. Xyloglucan can be considered safe and other studies should be performed to confirm the usefulness in patients with moderate‐to‐severe diarrhea. Xyloglucan is effective and safe in moderate‐to‐severe diarrhea in children 3 months to 5 years.
Bibliography:	https://www.clinicaltrials.gov The trial is registered at (NCT 03357237). ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 The trial is registered at https://www.clinicaltrials.gov (NCT 03357237).
ISSN:	2048-7177 2048-7177
DOI:	10.1002/fsn3.3688