Ener Cagri Dinleyici1, Nazan Dalgic2, Sirin Guven3, Ozge Metin4, Olcay Yasa5, Zafer Kurugol6, Ozden Turel7, Gonul Tanir4, Ahmet Sami Yazar3, Vefik Arica8, Mesut Sancar9, Adem Karbuz8, Makbule Eren10, Metehan Ozen8, Ates Kara9, Yvan Vandenplas11. 1. Faculty of Medicine, Department of Pediatrics, Pediatric Intensive Care and Infectious Disease Unit, Eskisehir Osmangazi University, Eskisehir, Turkey. Electronic address: timboothtr@yahoo.com. 2. Division of Pediatric Infectious Diseases, Sisli Etfal Training and Research Hospital, Istanbul, Turkey. 3. Department of Pediatrics, Umraniye Education & Research Hospital, Istanbul, Turkey. 4. Pediatric Infectious Disease Unit, Dr. Sami Ulus Research and Training Hospital of Women's and Children's Health and Diseases, Ankara, Turkey. 5. Department of Pediatrics, Goztepe Training and Research Hospital, SB Istanbul Medeniyet University, Istanbul, Turkey. 6. Department of Pediatrics, Faculty of Medicine, Ege University, İzmir, Turkey. 7. Department of Pediatric Infectious Disease Unit, Faculty of Medicine, Bezmialem Vakif University, Istanbul, Turkey. 8. Department of Pediatrics, Okmeydani Education and Research Hospital, Istanbul, Turkey. 9. Faculty of Pharmacy, Clinical Pharmacy Department, Marmara University, Istanbul, Turkey. 10. Faculty of Medicine, Pediatric Infectious Disease Unit, Hacettepe University, Ankara, Turkey. 11. Department of Pediatrics, UZ Brussel, Vrije Universiteit Brussel, Brussels, Belgium.
Abstract
OBJECTIVE: Two randomized controlled clinical trials have shown that Lactobacillus (L) reuteri DSM 17938 reduces the duration of diarrhea in children hospitalized due to acute infectious diarrhea. This was the first trial evaluating the efficacy of L. reuteri DSM 17938 in outpatient children with acute infectious diarrhea. METHODS: This was a multicenter, randomized, single-blinded, case control clinical trial in children with acute watery diarrhea. A total of 64 children who presented at outpatient clinics were enrolled. The probiotic group received 1×10(8)CFU L. reuteri DSM 17938 for five days in addition to oral rehydration solution (ORS) and the second group was treated with ORS only. The primary endpoint was the duration of diarrhea (in hours). The secondary endpoint was the number of children with diarrhea at each day of the five days of intervention. Adverse events were also recorded. RESULTS: The mean duration of diarrhea was significantly reduced in the L. reuteri group compared to the control group (approximately 15h, 60.4±24.5h [95% CI: 51.0-69.7h] vs. 74.3±15.3h [95% CI: 68.7-79.9h], p<0.05). The percentage of children with diarrhea was lower in the L. reuteri group (13/29; 44.8%) after 48h than the control group (27/31; 87%; RR: 0.51; 95% CI: 0.34-0.79, p<0.01). From the 72nd hour of intervention onwards, there was no difference between the two groups in the percentage of children with diarrhea. No adverse effects related to L. reuteri were noted. CONCLUSION:L. reuteri DSM 17938 is effective, safe, and well-tolerated in outpatient children with acute infectious diarrhea.
RCT Entities:
OBJECTIVE: Two randomized controlled clinical trials have shown that Lactobacillus (L) reuteriDSM 17938 reduces the duration of diarrhea in children hospitalized due to acute infectious diarrhea. This was the first trial evaluating the efficacy of L. reuteriDSM 17938 in outpatientchildren with acute infectious diarrhea. METHODS: This was a multicenter, randomized, single-blinded, case control clinical trial in children with acute watery diarrhea. A total of 64 children who presented at outpatient clinics were enrolled. The probiotic group received 1×10(8)CFU L. reuteriDSM 17938 for five days in addition to oral rehydration solution (ORS) and the second group was treated with ORS only. The primary endpoint was the duration of diarrhea (in hours). The secondary endpoint was the number of children with diarrhea at each day of the five days of intervention. Adverse events were also recorded. RESULTS: The mean duration of diarrhea was significantly reduced in the L. reuteri group compared to the control group (approximately 15h, 60.4±24.5h [95% CI: 51.0-69.7h] vs. 74.3±15.3h [95% CI: 68.7-79.9h], p<0.05). The percentage of children with diarrhea was lower in the L. reuteri group (13/29; 44.8%) after 48h than the control group (27/31; 87%; RR: 0.51; 95% CI: 0.34-0.79, p<0.01). From the 72nd hour of intervention onwards, there was no difference between the two groups in the percentage of children with diarrhea. No adverse effects related to L. reuteri were noted. CONCLUSION:L. reuteriDSM 17938 is effective, safe, and well-tolerated in outpatientchildren with acute infectious diarrhea.
Authors: Jennifer K Spinler; Jennifer Auchtung; Aaron Brown; Prapaporn Boonma; Numan Oezguen; Caná L Ross; Ruth Ann Luna; Jessica Runge; James Versalovic; Alex Peniche; Sara M Dann; Robert A Britton; Anthony Haag; Tor C Savidge Journal: Infect Immun Date: 2017-09-20 Impact factor: 3.441
Authors: Shelui Collinson; Andrew Deans; April Padua-Zamora; Germana V Gregorio; Chao Li; Leonila F Dans; Stephen J Allen Journal: Cochrane Database Syst Rev Date: 2020-12-08