Probiotic Weizmannia coagulans MTCC 5856 as adjunct therapy in children's acute diarrhea—a randomized, double-blind, placebo-controlled study
ObjectivesAcute diarrhea in children is generally managed by replacing the lost fluid with oral rehydration solution (ORS). Probiotic supplementation has been reported to reduce the severity of diarrhea. In the present study, we investigated the effect of Weizmannia coagulans (Bacillus coagulans) MT...
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Frontiers Media S.A.
2024-01-01
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| Series: | Frontiers in Pediatrics |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fped.2023.1338126/full |
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| author | Muhammed Majeed Muhammed Majeed Kalyanam Nagabhushanam Sivakumar Arumugam Nagarjuna Chadalavada Jyotsna Seepana Thumjaa Annamalai Avinash Murali Priji Prakasan Lakshmi Mundkur |
| author_facet | Muhammed Majeed Muhammed Majeed Kalyanam Nagabhushanam Sivakumar Arumugam Nagarjuna Chadalavada Jyotsna Seepana Thumjaa Annamalai Avinash Murali Priji Prakasan Lakshmi Mundkur |
| author_sort | Muhammed Majeed |
| collection | DOAJ |
| description | ObjectivesAcute diarrhea in children is generally managed by replacing the lost fluid with oral rehydration solution (ORS). Probiotic supplementation has been reported to reduce the severity of diarrhea. In the present study, we investigated the effect of Weizmannia coagulans (Bacillus coagulans) MTCC 5856, along with ORS on acute diarrhea of all causes in non-hospitalized children.MethodsA total of 110 children of ages between 1 and 10 were enrolled in a double-blind placebo-controlled study and were randomly allocated to receive W. coagulans MTCC 5856 (4 × 108 spores, N = 54) + ORS and zinc (Zn) or a placebo (N = 56) + ORS and (Zn) for 5 days. The consistency of the stool, mean duration of diarrhea in hours, mean diarrhea frequency per day, and the dehydration status were collected as efficacy endpoints. Safety was evaluated by the occurrence of adverse events.ResultsThe mean age of the children was 5.55 ± 2.57 years (61 boys and 49 girls). The mean duration of diarrhea was 51.31 ± 20.99 h in the W. coagulans MTCC 5856 group and 62.74 ± 24.51 h in the placebo (p = 0.011) group. The frequency of diarrhea was lower in children supplemented with the probiotic, but the difference was not statistically significant. The perceived efficacy score and dehydration status improved significantly in the W. coagulans MTCC 5856 group compared with the placebo group. No adverse events were recorded.ConclusionThe results of the study suggest that W. coagulans MTCC 5856 could be supplemented along with ORS and zinc to reduce the duration of diarrhea in non-hospitalized children.Clinical Trial RegistrationClinicalTrials.gov, identifier CTRI/2022/06/043239. |
| first_indexed | 2024-03-08T15:31:29Z |
| format | Article |
| id | doaj.art-41e245d4a4794f598c4c25a0acd81069 |
| institution | Directory Open Access Journal |
| issn | 2296-2360 |
| language | English |
| last_indexed | 2024-03-08T15:31:29Z |
| publishDate | 2024-01-01 |
| publisher | Frontiers Media S.A. |
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| series | Frontiers in Pediatrics |
| spelling | doaj.art-41e245d4a4794f598c4c25a0acd810692024-01-10T04:25:47ZengFrontiers Media S.A.Frontiers in Pediatrics2296-23602024-01-011110.3389/fped.2023.13381261338126Probiotic Weizmannia coagulans MTCC 5856 as adjunct therapy in children's acute diarrhea—a randomized, double-blind, placebo-controlled studyMuhammed Majeed0Muhammed Majeed1Kalyanam Nagabhushanam2Sivakumar Arumugam3Nagarjuna Chadalavada4Jyotsna Seepana5Thumjaa Annamalai6Avinash Murali7Priji Prakasan8Lakshmi Mundkur9Research and Development, Sami-Sabinsa Group Limited, Peenya Industrial Area, Bangalore, IndiaResearch and Development, Sabinsa Corporation, East Windsor, NJ, United StatesResearch and Development, Sabinsa Corporation, East Windsor, NJ, United StatesResearch and Development, Sami-Sabinsa Group Limited, Peenya Industrial Area, Bangalore, IndiaDepartment of Pediatrics, Aditya Multispeciality Hospital, Guntur, IndiaDepartment of Pediatrics, Government Medical College and Government General Hospital (old RIMSGGH), Srikakulam, IndiaDepartment of Pediatrics, Aarupadai Veedu Medical College & Hospital (AVMCH), Pondicherry, IndiaResearch and Development, Sami-Sabinsa Group Limited, Peenya Industrial Area, Bangalore, IndiaResearch and Development, Sami-Sabinsa Group Limited, Peenya Industrial Area, Bangalore, IndiaResearch and Development, Sami-Sabinsa Group Limited, Peenya Industrial Area, Bangalore, IndiaObjectivesAcute diarrhea in children is generally managed by replacing the lost fluid with oral rehydration solution (ORS). Probiotic supplementation has been reported to reduce the severity of diarrhea. In the present study, we investigated the effect of Weizmannia coagulans (Bacillus coagulans) MTCC 5856, along with ORS on acute diarrhea of all causes in non-hospitalized children.MethodsA total of 110 children of ages between 1 and 10 were enrolled in a double-blind placebo-controlled study and were randomly allocated to receive W. coagulans MTCC 5856 (4 × 108 spores, N = 54) + ORS and zinc (Zn) or a placebo (N = 56) + ORS and (Zn) for 5 days. The consistency of the stool, mean duration of diarrhea in hours, mean diarrhea frequency per day, and the dehydration status were collected as efficacy endpoints. Safety was evaluated by the occurrence of adverse events.ResultsThe mean age of the children was 5.55 ± 2.57 years (61 boys and 49 girls). The mean duration of diarrhea was 51.31 ± 20.99 h in the W. coagulans MTCC 5856 group and 62.74 ± 24.51 h in the placebo (p = 0.011) group. The frequency of diarrhea was lower in children supplemented with the probiotic, but the difference was not statistically significant. The perceived efficacy score and dehydration status improved significantly in the W. coagulans MTCC 5856 group compared with the placebo group. No adverse events were recorded.ConclusionThe results of the study suggest that W. coagulans MTCC 5856 could be supplemented along with ORS and zinc to reduce the duration of diarrhea in non-hospitalized children.Clinical Trial RegistrationClinicalTrials.gov, identifier CTRI/2022/06/043239.https://www.frontiersin.org/articles/10.3389/fped.2023.1338126/fullWeizmannia coagulans (Bacillus coagulans) MTCC 5856acute diarrheadehydrationoral rehydration solutionchildrenprobiotics |
| spellingShingle | Muhammed Majeed Muhammed Majeed Kalyanam Nagabhushanam Sivakumar Arumugam Nagarjuna Chadalavada Jyotsna Seepana Thumjaa Annamalai Avinash Murali Priji Prakasan Lakshmi Mundkur Probiotic Weizmannia coagulans MTCC 5856 as adjunct therapy in children's acute diarrhea—a randomized, double-blind, placebo-controlled study Frontiers in Pediatrics Weizmannia coagulans (Bacillus coagulans) MTCC 5856 acute diarrhea dehydration oral rehydration solution children probiotics |
| title | Probiotic Weizmannia coagulans MTCC 5856 as adjunct therapy in children's acute diarrhea—a randomized, double-blind, placebo-controlled study |
| title_full | Probiotic Weizmannia coagulans MTCC 5856 as adjunct therapy in children's acute diarrhea—a randomized, double-blind, placebo-controlled study |
| title_fullStr | Probiotic Weizmannia coagulans MTCC 5856 as adjunct therapy in children's acute diarrhea—a randomized, double-blind, placebo-controlled study |
| title_full_unstemmed | Probiotic Weizmannia coagulans MTCC 5856 as adjunct therapy in children's acute diarrhea—a randomized, double-blind, placebo-controlled study |
| title_short | Probiotic Weizmannia coagulans MTCC 5856 as adjunct therapy in children's acute diarrhea—a randomized, double-blind, placebo-controlled study |
| title_sort | probiotic weizmannia coagulans mtcc 5856 as adjunct therapy in children s acute diarrhea a randomized double blind placebo controlled study |
| topic | Weizmannia coagulans (Bacillus coagulans) MTCC 5856 acute diarrhea dehydration oral rehydration solution children probiotics |
| url | https://www.frontiersin.org/articles/10.3389/fped.2023.1338126/full |
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