Skip to content
DraconiticResearch
Search Sources API
197,787 studies31 sourcesUpdated 33 min ago
Peer-reviewedCC BY 4.0Nutrients

Efficacy of a Limosilactobacillus reuteri DSM 17938 and BG-R46® Formulation in Predominantly Breastfed Infants with Infant Distress Syndrome: A Randomized Double-Blind Placebo-Controlled Trial

  • Flavia Indrio1
  • Luca Pecoraro1,2
  • Pierluigi Manni3
  • Valeria Verdesca3
  • Antonio Di Mauro4
4 affiliations
  1. 1Department of Experimental Medicine, Pediatric Section, Medical School MedTech, University of Salento, 73100 Lecce, Italy
  2. 2Pediatric Unit, Ospedale Vito Fazzi, ASL Lecce, 73100 Lecce, Italy
  3. 3Pediatric Primary Care, National Pediatric Health Care System, ASL Lecce, 73100 Lecce, Italy
  4. 4Pediatric Primary Care, National Pediatric Health Care System, ASL Bari, 70100 Bari, Italy
Open at sourceDOICite

Abstract

Background: Infant distress syndrome, previously termed Infantile colic, is a common disorder of gut–brain interaction characterized by excessive crying and impaired behavioral regulation. Although Limosilactobacillus reuteri DSM 17938 has shown efficacy in predominantly breastfed infants, treatment responses remain variable, highlighting the need to investigate alternative probiotic formulations. BG-R46™, a strain derived from DSM 17938, exhibits distinct properties in preclinical models, providing a rationale for evaluating the combined formulation. This study investigated the efficacy and tolerability of DSM 17938 plus BG-R46™ compared with placebo in infants with infantile colic. Methods: In this randomized, double-blind, placebo-controlled trial, 50 infants were randomized to receive either the probiotic formulation or placebo for 21 days. Forty-eight infants (24 per group) were included in the intention-to-treat and per-protocol analyses. The primary endpoint was the change from baseline to Day 7 in total infant distress time, defined as the sum of awake fussing, crying, and inconsolable crying recorded using the Baby’s Day Diary®. Secondary outcomes included crying time, infant behavioral regulation (sleep duration, awake and content behavior, awake fussing, and inconsolable crying), maternal emotional well-being assessed using the Edinburgh Postnatal Depression Scale (EPDS), and safety. Results: Baseline infant distress time was comparable between groups. At Day 7, infant distress time decreased by 43% in the probiotic group versus 13% in the placebo group (−236.0 ± 111.5 vs. −66.7 ± 100.1 min/day; p < 0.001). At Day 21, reductions reached 62% and 26%, respectively. The probiotic formulation was well tolerated throughout the study. Conclusions: Supplementation with L. reuteri DSM 17938 plus L. reuteri BG-R46™ significantly reduced infant distress compared with placebo.

Related

  1. Limosilactobacillus reuteri for oral mucositis in patients undergoing radiotherapy for malignant head and neck tumors: a randomized controlled trial.
    Kun Gao, Yuan-Tai Li, Yi-Yan Pei +10
    Nature communicationsPeer-reviewedCC BYFull textGeneral medicineEurope PMCPMC
  2. Efficacy and safety of Limosilactobacillus reuteri DSM 17938 for the treatment of acute gastroenteritis in children: a systematic review and meta-analysis of randomized controlled trials
    Ener Cagri Dinleyici, Flavia Indrio, Pedro Gutierrez-Castrellon +1
    Frontiers in pediatricsPeer-reviewedCC BYFull textGeneral medicineEurope PMCPMC
  3. Comparative evaluation of the antipyretic and analgesic efficacy and safety of a fast-release paracetamol 650 mg formulation vs. conventional paracetamol formulations in adults with acute febrile or febrile-pain conditions: a multicenter randomized controlled trial
    Susobhan Mondal, S. K. Ashik Ikbal, Sumit Agrawal +11
    Frontiers in pain research (Lausanne, Switzerland)Peer-reviewedCC BYFull textGeneral medicineEurope PMC
  4. Effects of a hand sanitizer formulation on upper respiratory symptoms and work restrictions: a double-blind household cluster-randomized controlled trial
    Nami Yamanaka, Kaori Mizukoshi, Kentaro Asaoka +3
    Scientific ReportsPeer-reviewedCC BY 4.0Full textInfectious diseaseCrossref
  5. A Dual-Species Plant-derived Extracellular Vesicle and Growth Factors Formulation for Hair and Scalp Care: A Randomized, Placebo-controlled Study
    T.-M. Chang, C.-C. Wu, H.-C. Huang +9
    medRxivPreprintCC BY-NC-NDFull textGeneral medicinemedRxiv

Cite

BibTeXRIS
BibTeX
@article{indrio2026efficacy,
  title = {{Efficacy of a Limosilactobacillus reuteri DSM 17938 and BG-R46® Formulation in Predominantly Breastfed Infants with Infant Distress Syndrome: A Randomized Double-Blind Placebo-Controlled Trial}},
  author = {Flavia Indrio and Luca Pecoraro and Pierluigi Manni and Valeria Verdesca and Antonio Di Mauro},
  journal = {Nutrients},
  year = {2026},
  month = oct,
  doi = {10.3390/nu18213468},
  url = {https://www.mdpi.com/2072-6643/18/21/3468},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Efficacy of a Limosilactobacillus reuteri DSM 17938 and BG-R46® Formulation in Predominantly Breastfed Infants with Infant Distress Syndrome: A Randomized Double-Blind Placebo-Controlled Trial
AU  - Flavia Indrio
AU  - Luca Pecoraro
AU  - Pierluigi Manni
AU  - Valeria Verdesca
AU  - Antonio Di Mauro
PY  - 2026
DA  - 2026/10/22
JO  - Nutrients
DO  - 10.3390/nu18213468
UR  - https://www.mdpi.com/2072-6643/18/21/3468
AB  - Background: Infant distress syndrome, previously termed Infantile colic, is a common disorder of gut–brain interaction characterized by excessive crying and impaired behavioral regulation. Although Limosilactobacillus reuteri DSM 17938 has shown efficacy in predominantly breastfed infants, treatment responses remain variable, highlighting the need to investigate alternative probiotic formulations. BG-R46™, a strain derived from DSM 17938, exhibits distinct properties in preclinical models, providing a rationale for evaluating the combined formulation. This study investigated the efficacy and tolerability of DSM 17938 plus BG-R46™ compared with placebo in infants with infantile colic. Methods: In this randomized, double-blind, placebo-controlled trial, 50 infants were randomized to receive either the probiotic formulation or placebo for 21 days. Forty-eight infants (24 per group) were included in the intention-to-treat and per-protocol analyses. The primary endpoint was the change from baseline to Day 7 in total infant distress time, defined as the sum of awake fussing, crying, and inconsolable crying recorded using the Baby’s Day Diary®. Secondary outcomes included crying time, infant behavioral regulation (sleep duration, awake and content behavior, awake fussing, and inconsolable crying), maternal emotional well-being assessed using the Edinburgh Postnatal Depression Scale (EPDS), and safety. Results: Baseline infant distress time was comparable between groups. At Day 7, infant distress time decreased by 43% in the probiotic group versus 13% in the placebo group (−236.0 ± 111.5 vs. −66.7 ± 100.1 min/day; p < 0.001). At Day 21, reductions reached 62% and 26%, respectively. The probiotic formulation was well tolerated throughout the study. Conclusions: Supplementation with L. reuteri DSM 17938 plus L. reuteri BG-R46™ significantly reduced infant distress compared with placebo.
SN  - 2072-6643
ER  -