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Journal World Journal of Gastroenterology

Manuscript Type Randomized Controlled Trial
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Manuscript Number 7470
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Manuscript Title Resolution of acute gastroenteritis symptoms in children and adults treated with a novel polyphenol-based prebiotic

All Authors Telma Noguera, Robert Wotring, Chris R Melville, Kara Hargraves, Jochen Kumm, John M Morton

Manuscript Source
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Submit User Robert G Wotring
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Correspondence to John M. Morton, MD, MPH Stanford Digestive Health Center, 145 Tasso St, Palo Alto, CA 94301 [email protected]
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Article Scope Clinical Practice
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Specialty Type Gastroenterology and Hepatology
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Keywords Gastroenteritis,Prebiotic,Polyphenol,Diarrhea,Acute
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Core Tip The global standard of care for treating acute gastroenteritis in children is 5-10 days of oral rehydration therapy, which saves lives and may reduces the duration of the illness by 20%. In this double-blind, placebo-controlled clinical study, 60% and 89% of subjects receiving a novel polyphenol-based prebiotic experienced their last unformed stool within two hours, and 24 hrs, respectively. This represents an extraordinary advance in the clinical management of acute gastroenteritis. If other research sites are able to repeat these results with different populations, they should become the new global standard of care.

Abstract Introduction: Acute gastroenteritis is a prevalent disease with persistent morbidity and mortality. Acute gastroenteritis has multiple causative agents. Current treatment methods are essentially supportive in nature with oral rehydration widely considered to be the primary treatment. The role of polyphenols-based prebiotics in treating acute gastroenteritis has not been examined to date. Methods: A two-arm randomized, double-blinded, placebo-controlled clinical study was conducted at two public health centers in Managua, Nicaragua. Potential subjects who qualified based on inclusion/exclusion criteria were randomly assigned to one of two treatment arms. Two thirds of the subjects (N=200) received 2 liquid ounces of a novel polyphenol-based prebiotic (AlivaTM) diluted in 8 ounces of oral rehydration solution (ORS). One third of the subjects (N=100) were randomized to receive 2 liquid ounces of a taste and color-matched placebo diluted in 8 ounces of ORS. The primary outcome variable measured the time to last unformed stool (TTLUS) after treatment. The secondary outcome variables measuring stomach discomfort; gas & bloating; and heartburn/indigestion were also determined. Results: The percentage of subjects recording their last unformed stool was lower for those who received Aliva vs. placebo at 30 minutes (P < 0.01), 2 hours (P < 0.001), 24 hours (P < 0.001), 72 hours (P < 0.001), and 5 days (P < 0.01). In addition, there were statistically significant improvements in self-reported secondary outcomes as early as 90 minutes after ingestion in the prebiotic vs. placebo treatment group. Conclusion: In this double-blind, randomized clinical study, subjects with acute gastroenteritis receiving Aliva showed significant improvement of multiple associated symptoms vs. those receiving placebo
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Cover Letter We are pleased to present the remarkable results of our research for consideration in your esteemed journal. As you are likely aware, our corresponding author John M. Morton, M.D. of Stanford University, is a member of your editorial board and the president elect of the American Society of Metabolic and Bariatric Surgery. We are confident you'll find the results herein compelling and extraordinary. We look forward to receiving your feedback and look forward to the opportunity to address any questions you may have. Please feel free to reach out to me with questions via email at [email protected] or by phone at (650) 644-5377. Respectfully, Robert Wotring

Manuscript 7470-Editted.pdf
 
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