Probiotics for children with uncomplicated severe acute malnutrition (PruSAM study) : A randomized controlled trial in the Democratic Republic of Congo
Copyright © 2023 American Society for Nutrition. Published by Elsevier Inc. All rights reserved..
BACKGROUND: Severe acute malnutrition (SAM) contributes to nearly 1 million deaths annually worldwide, with diarrhea and pneumonia being the common morbidity associated with mortality.
OBJECTIVES: To assess the effect of probiotics on diarrhea, pneumonia, and nutritional recovery in children with uncomplicated SAM.
METHODS: A randomized, double-blind, placebo-controlled study was conducted involving 400 children with uncomplicated SAM randomly assigned to ready-to-use therapeutic food (RUTF) either with (n = 200) or without (n = 200) probiotics. Patients received 1 mL daily dose of a blend of Lacticasebacillus rhamnosus GG and Limosilactobacillus reuteri DSM 17938 (dosage, 2 billion colony-forming units; 50:50) or placebo during 1 mo. They were simultaneously fed with the RUTF for 6 to 12 wk, depending on patients' recovery rates. The primary outcome was the duration of diarrhea. Secondary outcomes included diarrheal and pneumonic incidence, nutritional recovery, and transfer to inpatient care rate.
RESULTS: For children with diarrhea, the number of days of disease was lower in the probiotic group (4.11; 95% CI: 3.37, 4.51) than that in the placebo group (6.68; 95% CI: 6.26, 7.13; P < 0.001). For children aged 16 mo or older, the risk of diarrhea was lower in the probiotic group (75.6%; 95% CI: 66.2, 82.9) than that in the placebo group (95.0%; 95% CI: 88.2, 97.9; P < 0.001), but no significant difference of the risk for the youngest. In the probiotic group, nutritional recovery happened earlier: at the 6th wk, 40.6% of the infants were waiting for nutritional recovery, contrasting with 68.7% of infants in the placebo group; but the nutritional recovery rate at the 12th wk was similar between the groups. Probiotics had no effect on pneumonic incidence and transfer to inpatient care.
CONCLUSIONS: This trial supports using probiotics for the treatment of children with uncomplicated SAM. Its effect on diarrhea could positively affect nutritional programs in resource-limited settings. This trial was registered https://pactr.samrc.ac.za as PACTR202108842939734.
| Errataetall: |
CommentIn: Am J Clin Nutr. 2023 May;117(5):842-843. - PMID 37137613 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:117 |
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| Enthalten in: |
The American journal of clinical nutrition - 117(2023), 5 vom: 09. Mai, Seite 976-984 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Kambale, Richard Mbusa [VerfasserIn] |
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| Links: |
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| Themen: |
Diarrhea |
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| Anmerkungen: |
Date Completed 05.05.2023 Date Revised 09.05.2023 published: Print-Electronic PACTR: PACTR202108842939734 CommentIn: Am J Clin Nutr. 2023 May;117(5):842-843. - PMID 37137613 Citation Status MEDLINE |
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| doi: |
10.1016/j.ajcnut.2023.01.019 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 100 | 1 | |a Kambale, Richard Mbusa |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Probiotics for children with uncomplicated severe acute malnutrition (PruSAM study) |b A randomized controlled trial in the Democratic Republic of Congo |
| 264 | 1 | |c 2023 | |
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| 500 | |a Date Completed 05.05.2023 | ||
| 500 | |a Date Revised 09.05.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a PACTR: PACTR202108842939734 | ||
| 500 | |a CommentIn: Am J Clin Nutr. 2023 May;117(5):842-843. - PMID 37137613 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2023 American Society for Nutrition. Published by Elsevier Inc. All rights reserved. | ||
| 520 | |a BACKGROUND: Severe acute malnutrition (SAM) contributes to nearly 1 million deaths annually worldwide, with diarrhea and pneumonia being the common morbidity associated with mortality | ||
| 520 | |a OBJECTIVES: To assess the effect of probiotics on diarrhea, pneumonia, and nutritional recovery in children with uncomplicated SAM | ||
| 520 | |a METHODS: A randomized, double-blind, placebo-controlled study was conducted involving 400 children with uncomplicated SAM randomly assigned to ready-to-use therapeutic food (RUTF) either with (n = 200) or without (n = 200) probiotics. Patients received 1 mL daily dose of a blend of Lacticasebacillus rhamnosus GG and Limosilactobacillus reuteri DSM 17938 (dosage, 2 billion colony-forming units; 50:50) or placebo during 1 mo. They were simultaneously fed with the RUTF for 6 to 12 wk, depending on patients' recovery rates. The primary outcome was the duration of diarrhea. Secondary outcomes included diarrheal and pneumonic incidence, nutritional recovery, and transfer to inpatient care rate | ||
| 520 | |a RESULTS: For children with diarrhea, the number of days of disease was lower in the probiotic group (4.11; 95% CI: 3.37, 4.51) than that in the placebo group (6.68; 95% CI: 6.26, 7.13; P < 0.001). For children aged 16 mo or older, the risk of diarrhea was lower in the probiotic group (75.6%; 95% CI: 66.2, 82.9) than that in the placebo group (95.0%; 95% CI: 88.2, 97.9; P < 0.001), but no significant difference of the risk for the youngest. In the probiotic group, nutritional recovery happened earlier: at the 6th wk, 40.6% of the infants were waiting for nutritional recovery, contrasting with 68.7% of infants in the placebo group; but the nutritional recovery rate at the 12th wk was similar between the groups. Probiotics had no effect on pneumonic incidence and transfer to inpatient care | ||
| 520 | |a CONCLUSIONS: This trial supports using probiotics for the treatment of children with uncomplicated SAM. Its effect on diarrhea could positively affect nutritional programs in resource-limited settings. This trial was registered https://pactr.samrc.ac.za as PACTR202108842939734 | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a diarrhea | |
| 650 | 4 | |a infants | |
| 650 | 4 | |a low-income country | |
| 650 | 4 | |a probiotics | |
| 650 | 4 | |a uncomplicated severe acute malnutrition | |
| 700 | 1 | |a Ntagazibwa, Joseph Ntagerwa |e verfasserin |4 aut | |
| 700 | 1 | |a Kasengi, Joe Bwija |e verfasserin |4 aut | |
| 700 | 1 | |a Zigashane, Adrien Burume |e verfasserin |4 aut | |
| 700 | 1 | |a Francisca, Isia Nancy |e verfasserin |4 aut | |
| 700 | 1 | |a Mashukano, Benjamin Ntaligeza |e verfasserin |4 aut | |
| 700 | 1 | |a Amani Ngaboyeka, Gaylord |e verfasserin |4 aut | |
| 700 | 1 | |a Bahizire, Esto |e verfasserin |4 aut | |
| 700 | 1 | |a Zech, Francis |e verfasserin |4 aut | |
| 700 | 1 | |a Bindels, Laure B |e verfasserin |4 aut | |
| 700 | 1 | |a Van der Linden, Dimitri |e verfasserin |4 aut | |
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