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Lactobacillus Reuteri for the Treatment of Infantile Colic:

2014-08-27 03:16:46 | BioPortfolio

Summary

Infantile colic is characterized by excessive crying (defined as crying that last at least 3 hours a day, for 3 days a week, for at least 3 weeks) in an otherwise healthy infant. The crying typically starts in the first few weeks of life and ends by 4-5 months of age. The condition is usually self-limited, with no long-term adverse effects; however, it may be very distressing to parents, hence, any safe and effective treatment would be desirable. Recently, it has been suggested that probiotics may offer some benefit.This is based on the results of one open randomized controlled trial. In this trial, 83 breast-fed infants with colic defined as >3 hours of crying on >3 days/week were randomly allocated to receive Lactobacillus reuteri DSM 17938 (108 colony-forming units, once daily 30 minutes after feeding) or simethicone (60 mg/day as 15 drops twice a day after feeding) for 28 days. Mothers followed a cow's milk free diet. By day 28 after randomization, mothers of infants in the probiotic group were significantly more likely than mothers of infants in the simethicone group to report a reduction from baseline in average crying time to less than 3 hours per day (95% vs. 7%). In addition, median crying times were significantly shorter in the probiotic group than in the simethicone group. No adverse effects of L. reuteri were reported.

Although the mechanism of action of L. reuteri for treating infantile colic has not been elucidated yet, the findings are very promising. However, there are some methodological limitations to the study, including no allocation concealment, no blinding, and no intention-to-treat analysis; these may result in selection, performance, and/or attrition biases and, eventually, invalidate the results. Another limitation of the study is the lack of a true placebo group. Given these consideration a new study is proposed that is aiming to overcome these limitations.

Description

Eligible infants will be randomly assigned to receive either L. reuteri 108 CFU per day or placebo. Both the active treatment and placebo will be taken orally, 1 times daily, for 21 days.

All infants are eligible for screening. If a patient appears to meet the criteria for enrollment and express interest in the study, cow's milk elimination diet will be prescribed for 1 week to a breastfeeding mother (and to an infant, in case of formula fed infants). Care givers will be asked to record for 1 week symptoms of colic. Children fulfilling inclusion criteria will be asked to participate in the study.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Infantile Colic

Intervention

Lactobacillus reuteri (DSM 17938)

Location

The Medical University of Warsaw, Outpatient Clinic
Warsaw
Poland
01-184

Status

Recruiting

Source

Warsaw Medical University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:46-0400

Clinical Trials [271 Associated Clinical Trials listed on BioPortfolio]

Clinical Trial of L. Reuteri in Infantile Colic 2017

RCT to evaluate the safety and efficacy of Lactobacillus reuteri DSM 17938 to significantly reduce the duration of crying time and fussines in infants from 15days to 4 months of age with c...

Lactobacillus Reuteri DSM 17938 Versus Placebo in the Treatment of Infantile Colic

Infantile colic is a common medical condition which remains a frustrating problem for parents and health care providers with no clear treatment guidelines. To fill the void in existing lit...

Lactobacillus Reuteri Versus Placebo in the Treatment of Infantile Colic

The purpose of this study is: - to study the intestinal microflora of colicky infants before and after L. reuteri or placebo administration, evaluating the effect of Lactobacillus...

Prevention of Colic With the Probiotic Lactobacillus Reuteri

Colic is a term for inconsolable crying happened in the first months of life. Its etiology is multifactorial and caregiver and pediatrician generates among other problems: anxiety, risk of...

Effectiveness of Probiotic Supplementation on Crying Time in Infantile Colic

This study aims to investigate the effectiveness of Lactobacillus reuteri DSM17938 supplementation on infantile colic in Indonesian infants.

PubMed Articles [418 Associated PubMed Articles listed on BioPortfolio]

Protective effect of Lactobacillus reuteri DSM 17938 against experimental necrotizing enterocolitis is mediated by Toll-like receptor 2.

Lactobacillus reuteri DSM 17938 (LR 17938) has been shown to reduce the incidence and severity of necrotizing enterocolitis (NEC). It is unclear if preventing NEC by LR 17938 is mediated by toll-like ...

Maternal Intrapartum Antibiotic Administration and Infantile Colic: Is there a Connection?

The aetiology of infantile colic remains unknown. However, altered gut microbiota composition has been reported in children with the disorder.

Effect of Reflexology on Infantile Colic.

The aim of this study was to explore the effect of reflexology on infantile colic.

Two-step production of anti-inflammatory soluble factor by Lactobacillus reuteri CRL 1098.

We have demonstrated previously that a soluble factor (LrS) produced by Lactobacillus (L.) reuteri CRL 1098 modulates the inflammatory response triggered by lipopolysaccharide. In this study, the prod...

Effect of Probiotic Lactobacillus reuteri on Salivary Cariogenic Bacterial Counts among Groups of Preschool Children in Jeddah, Saudi Arabia: A Randomized Clinical Trial.

To evaluate the effect of probiotic Lactobacilli reuteri lozenges on caries-associated salivary bacterial counts (Mutans streptococci and Lactobacillus), dental plaque accumulation, and salivary buffe...

Medical and Biotech [MESH] Definitions

A species of gram-positive, rod-shaped LACTIC ACID bacteria found naturally in the human intestinal flora and BREAST MILK.

A species of Lactobacillus that occurs in the human GASTROINTESTINAL TRACT and ORAL MUCOSA. It produces BACTERIOCINS and is used as a PROBIOTIC.

A species of Lactobacillus that occurs in the human GASTROINTESTINAL TRACT and VAGINA. It produces BACTERIOCINS and HYDROGEN PEROXIDE and is used as a PROBIOTIC.

A species of Lactobacillus that occurs in fermented meat and fish. It produces the BACTERIOCIN Sakacin P and is used for FOOD PRESERVATION and as a PROBIOTIC.

A species of Lactobacillus that occurs in the human ORAL MUCOSA; GASTROINTESTINAL TRACT; and VAGINA. It produces BACTERIOCINS, can modulate the immune response, and is used as a PROBIOTIC.

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