Trial reportThe Journal of pediatrics2017
Lactobacillus reuteri for Infants with Colic: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial.
Trial report in The Journal of pediatrics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01849991 (Safety and Effect of L. Reuteri on Biomarkers of Inflammation in Healthy Infants With Colic), which is not on this map. Cited by 30 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Safety and Effect of L. Reuteri on Biomarkers of Inflammation in Healthy Infants With Colic
Who cites it
30 citing papers in PubMed, 3 syntheses or guidelines pooled it, 66 citations in OpenAlex.
- Probiotic supplementation is associated with higher faecal secretory IgA (sIgA) in healthy full-term infants: a systematic review and meta-analysis.Pediatric research · 2026Pooled it
- Faecal Microbiota in Infants and Young Children with Functional Gastrointestinal Disorders: A Systematic Review.Nutrients · 2022Pooled it
- Probiotic Supplementation During the Perinatal and Infant Period: Effects on Gut Dysbiosis and Disease.Nutrients · 2020Pooled it
- Assessment trial of the effect of enteral insulin on the preterm infant intestinal microbiota.Pediatric research · 2024Trial
- Infant behavioral state and stool microbiome in infants receiving Lactocaseibacillus rhamnosus GG in formula: randomized controlled trial.BMC pediatrics · 2022Trial
- Safety of Lactobacillus Reuteri DSM 17938 in Healthy Children 2-5 Years of Age.The Pediatric infectious disease journal · 2019Trial
- Infantile Colic: When to Suspect Cow's Milk Allergy.Nutrients · 2025Review
- Infant Colic Symptoms and Amino Acid Formula: Insights from a Prospective Cohort Study.Nutrients · 2025Article
- Preventing and Treating Colic: An Update.Advances in experimental medicine and biology · 2024Review
- Review
- Review
- Intestinal Inflammation is Significantly Associated With Length Faltering in Preterm Infants at Neonatal Intensive Care Unit Discharge.Journal of pediatric gastroenterology and nutrition · 2022Article
- Treg-associated monogenic autoimmune disorders and gut microbial dysbiosis.Pediatric research · 2022Review
- An Observational Real-Life Study with a New Infant Formula in Infants with Functional Gastro-Intestinal Disorders.Nutrients · 2021Observational
- Breast Milk, a Source of Beneficial Microbes and Associated Benefits for Infant Health.Nutrients · 2020Review
- The Effect of Probiotics on Symptoms, Gut Microbiota and Inflammatory Markers in Infantile Colic: A Systematic Review, Meta-Analysis and Meta-Regression of Randomized Controlled Trials.Journal of clinical medicine · 2020Review
- Probiotics and oxytocin nasal spray as neuro-social-behavioral interventions for patients with autism spectrum disorders: a pilot randomized controlled trial protocol.Pilot and feasibility studies · 2020Article
- Pretreatment withDrug design, development and therapy · 2020Article
- Coconut milk beverage fermented byJournal of food science and technology · 2019Article
- Lactobacillus reuteri DSM 17938 Protects against Gastric Damage Induced by Ethanol Administration in Mice: Role of TRPV1/Substance P Axis.Nutrients · 2019Article
Corrections and comments
- Commented on by
Authors and funding
18 authors at 4 institutions in 1 country.
Funding
Abstract
objectiveTo assess the safety of probiotic Lactobacillus reuteri strain Deutsche Sammlung von Mikroorganismen (DSM) 17938 with daily administration to healthy infants with colic and to determine the effect of L reuteri strain DSM 17938 on crying, fussing, inflammatory, immune, and microbiome variables. STUDY
designWe performed a controlled, double-blinded, phase 1 safety and tolerability trial in healthy breast-fed infants with colic, aged 3 weeks to 3 months, randomly assigned to L reuteri strain DSM 17938 (5 × 10
resultsOf 117 screened infants, 20 were randomized to L reuteri strain DSM 17938 or placebo (sunflower oil) (in a 2:1 ratio) with 80% retention. Eleven of the 20 (55%) presented with low absolute neutrophil counts (<1500/mm
conclusionsDaily administration of L reuteri strain DSM 17938 appears to be safe in newborn infants with colic, including those with neutropenia, which frequently coexists. A placebo response of 66% suggests that many infants with colic will have resolution within 3 weeks.
trial registrationClinicalTrials.gov: NCT01849991.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.