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Resolution of acute gastroenteritis symptoms in children and adults treated with a novel polyphenol-based prebiotic.
World J Gastroenterol. 2014 Sep 14; 20(34):12301-7.WJ

Abstract

AIM

To test efficacy and durability of a polyphenol-based prebiotic treatment for acute gastroenteritis in a 300 patient double-blinded clinical study.

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 and exclusion criteria were randomly assigned to one of two treatment arms. Two thirds of the subjects (n = 200) received a single titrated 0.5-2 ounce liquid dose of a novel polyphenol-based prebiotic (Aliva(TM)) diluted with 2 to eight ounces of oral rehydration solution (ORS). One third of the subjects (n = 100) were randomized to receive two liquid ounces of a taste and color-matched placebo diluted in eight ounces of ORS. The outcome variables measured included stool consistency, stomach discomfort, gas and bloating, and heartburn/indigestion. The study subjects ranked their stool consistency and the severity of their subjective symptoms at specified intervals from immediately prior to treatment, to five days post treatment. All subjects recorded their symptoms in a study diary. The study subjects also recorded the time and consistencies of all stools in their study diary. Stool consistency was compared to the picture and descriptions on the Bristol Stool Chart, and any stool rated greater than Type 4 was considered unformed. The clinical study team reviewed the study diaries with subjects during daily follow-up calls and close-out visits, and recorded the data in case report forms.

RESULTS

After receiving a single dose, Aliva treated subjects reported shorter median time to their last unformed stool (1 h 50 min) than placebo treated subjects (67 h 50 min.), a statistically significant difference [95%CI: -3178-(-2018), P = 0.000]. Aliva treated subjects also reported shorter median their time to last unformed stool (TTLUS) (1 hrs 50 min) than placebo treated subjects (67 h 50 min), which was also a statistically significant difference (P = 0.000).The percentage of subjects recording TTLUS was greater for those who received Aliva vs placebo at 30 min (P = 0.027), 2 h (P = 0.000), 24 h (P = 0.000), 48 h (P = 0.000), 72 h (P = 0.000), and 5 d (P = 0.000) post dose. There were 146 study subjects 14 years old or older, which was the criteria set for reliable self-reporting of subjective symptoms. Of those 146 subjects, 142 reported stomach pain and discomfort during screening. From 90 minutes [95%CI: -1.8-(-0.01), P = 0.048] through 5 d [95%CI: -3.4-(-1.9), P = 0.000), the subjects treated with Aliva experienced significantly less stomach pain and discomfort than those who received placebo. Of those same 146 participants, 114 subjects reported gas and bloating during screening. Similarly, subjects who received Aliva experienced significantly less gas and bloating from 2 h [95%CI: -1.7-(-0.39), P = 0.030] through 5 d (95%CI: -2.0-0.42, P = 0.005) compared with the placebo arm.

CONCLUSION

In this double-blind, randomized clinical study, subjects with acute gastroenteritis receiving Aliva prebiotic showed significant and sustained improvement of multiple symptoms vs those receiving placebo.

Authors+Show Affiliations

Telma Noguera, Instituto Centroamericano de Investigación Clínica, Managua 050-008-4, Nicaragua.Telma Noguera, Instituto Centroamericano de Investigación Clínica, Managua 050-008-4, Nicaragua.Telma Noguera, Instituto Centroamericano de Investigación Clínica, Managua 050-008-4, Nicaragua.Telma Noguera, Instituto Centroamericano de Investigación Clínica, Managua 050-008-4, Nicaragua.Telma Noguera, Instituto Centroamericano de Investigación Clínica, Managua 050-008-4, Nicaragua.Telma Noguera, Instituto Centroamericano de Investigación Clínica, Managua 050-008-4, Nicaragua.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

25232265

Citation

Noguera, Telma, et al. "Resolution of Acute Gastroenteritis Symptoms in Children and Adults Treated With a Novel Polyphenol-based Prebiotic." World Journal of Gastroenterology, vol. 20, no. 34, 2014, pp. 12301-7.
Noguera T, Wotring R, Melville CR, et al. Resolution of acute gastroenteritis symptoms in children and adults treated with a novel polyphenol-based prebiotic. World J Gastroenterol. 2014;20(34):12301-7.
Noguera, T., Wotring, R., Melville, C. R., Hargraves, K., Kumm, J., & Morton, J. M. (2014). Resolution of acute gastroenteritis symptoms in children and adults treated with a novel polyphenol-based prebiotic. World Journal of Gastroenterology, 20(34), 12301-7. https://doi.org/10.3748/wjg.v20.i34.12301
Noguera T, et al. Resolution of Acute Gastroenteritis Symptoms in Children and Adults Treated With a Novel Polyphenol-based Prebiotic. World J Gastroenterol. 2014 Sep 14;20(34):12301-7. PubMed PMID: 25232265.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Resolution of acute gastroenteritis symptoms in children and adults treated with a novel polyphenol-based prebiotic. AU - Noguera,Telma, AU - Wotring,Robert, AU - Melville,Chris R, AU - Hargraves,Kara, AU - Kumm,Jochen, AU - Morton,John M, PY - 2013/11/20/received PY - 2014/05/15/revised PY - 2014/06/12/accepted PY - 2014/9/19/entrez PY - 2014/9/19/pubmed PY - 2015/5/16/medline KW - Aliva KW - Dehydration KW - Diarrhea KW - Gastroenteritis KW - Greenteaspoon KW - Heartburn KW - Infant Mortality KW - Polyphenol KW - Prebiotic KW - Rotavirus SP - 12301 EP - 7 JF - World journal of gastroenterology JO - World J. Gastroenterol. VL - 20 IS - 34 N2 - AIM: To test efficacy and durability of a polyphenol-based prebiotic treatment for acute gastroenteritis in a 300 patient double-blinded clinical study. 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 and exclusion criteria were randomly assigned to one of two treatment arms. Two thirds of the subjects (n = 200) received a single titrated 0.5-2 ounce liquid dose of a novel polyphenol-based prebiotic (Aliva(TM)) diluted with 2 to eight ounces of oral rehydration solution (ORS). One third of the subjects (n = 100) were randomized to receive two liquid ounces of a taste and color-matched placebo diluted in eight ounces of ORS. The outcome variables measured included stool consistency, stomach discomfort, gas and bloating, and heartburn/indigestion. The study subjects ranked their stool consistency and the severity of their subjective symptoms at specified intervals from immediately prior to treatment, to five days post treatment. All subjects recorded their symptoms in a study diary. The study subjects also recorded the time and consistencies of all stools in their study diary. Stool consistency was compared to the picture and descriptions on the Bristol Stool Chart, and any stool rated greater than Type 4 was considered unformed. The clinical study team reviewed the study diaries with subjects during daily follow-up calls and close-out visits, and recorded the data in case report forms. RESULTS: After receiving a single dose, Aliva treated subjects reported shorter median time to their last unformed stool (1 h 50 min) than placebo treated subjects (67 h 50 min.), a statistically significant difference [95%CI: -3178-(-2018), P = 0.000]. Aliva treated subjects also reported shorter median their time to last unformed stool (TTLUS) (1 hrs 50 min) than placebo treated subjects (67 h 50 min), which was also a statistically significant difference (P = 0.000).The percentage of subjects recording TTLUS was greater for those who received Aliva vs placebo at 30 min (P = 0.027), 2 h (P = 0.000), 24 h (P = 0.000), 48 h (P = 0.000), 72 h (P = 0.000), and 5 d (P = 0.000) post dose. There were 146 study subjects 14 years old or older, which was the criteria set for reliable self-reporting of subjective symptoms. Of those 146 subjects, 142 reported stomach pain and discomfort during screening. From 90 minutes [95%CI: -1.8-(-0.01), P = 0.048] through 5 d [95%CI: -3.4-(-1.9), P = 0.000), the subjects treated with Aliva experienced significantly less stomach pain and discomfort than those who received placebo. Of those same 146 participants, 114 subjects reported gas and bloating during screening. Similarly, subjects who received Aliva experienced significantly less gas and bloating from 2 h [95%CI: -1.7-(-0.39), P = 0.030] through 5 d (95%CI: -2.0-0.42, P = 0.005) compared with the placebo arm. CONCLUSION: In this double-blind, randomized clinical study, subjects with acute gastroenteritis receiving Aliva prebiotic showed significant and sustained improvement of multiple symptoms vs those receiving placebo. SN - 2219-2840 UR - https://www.unboundmedicine.com/medline/citation/25232265/Resolution_of_acute_gastroenteritis_symptoms_in_children_and_adults_treated_with_a_novel_polyphenol_based_prebiotic_ L2 - http://www.wjgnet.com/1007-9327/full/v20/i34/12301.htm DB - PRIME DP - Unbound Medicine ER -