Use Of Probiotics In Prevention And Treatment Of Clinical Diseases
Reviews on the clinical applications of probiotics and prebiotics can be found in the references.,,, Results of evidence-based analyses of the clinical effectiveness of probiotics and prebiotics are discussed below. It must be stressed that the current lack of evidence of efficacy does not mean that future clinical research will not establish significant health benefits for probiotics and prebiotics.
Clinical Monitoring During Supplementation
Intolerance , probiotic sepsis and AEs of additives such as prebiotic oligosaccharides need to be monitored . However, the significant overlap of features of ileus of prematurity, sepsis and NEC is expected to make this issue very difficult. Frequent clinical examinations and a cautious approach are desirable until enough experience is obtained with a probiotic product and protocol in this high-risk cohort.
Cancer: Prevention And Treatment
Results of published studies have demonstrated the positive benefits of functional foods, such as yogurt, and the administration of probiotics to prevent carcinogenic processes in animal models. As yet, no published RCTs warrant recommendation of routine administration of probiotics to either treat or prevent cancer in adults or children.
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Role Of Prebiotics In Probiotic Products
The coexistence of probiotics and prebiotics, as found in human breast milk, is known to be synergistic . Prebiotics have been shown to enhance the survival of endogenous probiotic organisms . Further research, such as RCTs of probiotics versus synbiotics, is necessary to evaluate whether addition of prebiotics improves the survival and/or efficacy of probiotic strains in preterm neonates .
Selection Criteria For Rcts
Studies were included if they investigated the treatment or prevention of IC in full-term infants, were randomized by any method, included a control group, used any live probiotic, had a minimum of 15 participants in each group, were peer-reviewed and published in English . We excluded studies on primarily preterm infants and studies that looked exclusively at prenatal use of probiotics. For treatment trials, we included studies if they used Wessels or modified Wessels criteria to diagnose colic, and used a structured diary to record daily crying time as one of the measured outcomes . For prevention trials, we included studies if they used daily crying time or a surrogate outcome for crying/fussing, such as use of medications for colic and physician visits. We summarized SRs if they reviewed RCTs of any live probiotics for infantile colic.
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Data Extraction And Meta
Study details, including study population, characteristics of the intervention, use of placebo, and outcome, were assessed independently by AA and LC, and checked by DG. Study quality was evaluated independently using the risk of bias tool as proposed by the Cochrane collaboration . In addition, an assessment of the body of evidence using the GRADE working group approach was used in order to grade the quality of evidence. The evaluation was carried out following the Chapter 12 of the Cochrane Handbook and classifying the evidence as high, moderate, low and very low .
The association between probiotic use and NEC was evaluated by meta-analyses, conducted by AA and DG, using the RevMan software . Risk ratio was calculated using the Mantel-Haenszel method, and reported with 95 % confidence interval .
The following sub-meta-analyses were also performed, in order to evaluate the effect of probiotics:
A fixed-effect model was used for the analyses. Heterogeneity was measured using the I2 test. If significant heterogeneity was present , a random-effects model was used . The random-effects model was also used when heterogeneity was not significant but the number of studies was5, because the test for heterogeneity is known to have low power when the number of studies is small .
Forest plots were used to illustrate results from meta-analyses, and funnel plots to investigate bias.
The online version of GraphPad Quickcalcs software was used to calculate number needed to treat .
Probiotics In Infants For Prevention Of Allergic Disease And Food Hypersensitivity
There is insufficient evidence to recommend the addition of probiotics to infant feeds for prevention of allergic disease or food reactions. Reactions to foods and allergies are common and may be increasing in developed countries. Many infants become sensitised to foods, including infant formula, through their gastrointestinal tract, a process that may be affected by the composition of the intestinal bacteria. Attempts to promote the growth of normal gastrointestinal bacteria and prevent sensitisation to foods have included the use of probiotics. Probiotics are live bacteria that colonize the gastrointestinal tract and provide a health benefit to the host. This review found that probiotics added to infant feeds may help prevent infant eczema, with one study suggesting the benefit may persist to four years of age. However, concerns regarding the quality of studies, inconsistency of findings between studies, and the fact that the benefits did not persist if restricted to infants with evidence of sensitisation to allergens, suggests that further studies are needed to confirm these results.
To determine the effect of probiotics given to infants for the prevention of allergic disease or food hypersensitivity.
This included searches of the Cochrane Central Register of Controlled Trials , MEDLINE , EMBASE, PREMEDLINE, abstracts of conference proceedings and citations of published articles, and expert informants.
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Data Synthesis And Statistical Analysis
First, we performed pairwise meta-analyses with R software . We conducted random-effects model meta-analyses to obtain effect sizes for primary and secondary outcomes and presented dichotomous outcomes as risk ratio and continuous outcomes as standardized mean difference with 95% confidence interval separately.
Data Collection And Analysis
The process of study selection is presented using a PRISMA flow diagram . Data extraction for study characteristics and critical appraisal of RCTs was performed by one author and verified by another . The quality of evidence was evaluated using the risk of bias tool from the Cochrane Handbook on Systematic Reviews of Interventions and Review Manager and, where sufficient data were available, the GRADE criteria . While the risk of bias tool evaluates the quality of methods in each study, GRADE assesses the quality of evidence on the effectiveness of an intervention for a specific clinical outcome across studies, based on five dimensions: study design, risk of bias, inconsistency, indirectness, and imprecision . There are four possible GRADE scores: high , moderate , low , and very low . Any reported adverse events of using probiotics in infants were collected from the reviewed studies and from recent SRs/publications about the safety of probiotics in children.
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Safety Of Probiotics And Prebiotics In Infants And Children
Concerns exist about the overall safety of administering probiotic products to high-risk patient groups, including adults, children, and term and preterm infants. Cases of serious infection have occurred and been reported in the literature.,,, Patients at risk would be those who are immunocompromised, including ill preterm neonates, and/or children who have intravenous catheters or other indwelling medical devices. In most cases, the offending organism that caused the sepsis seems to have stemmed from bacteria from the individual’s own endogenous flora. Sepsis has also been reported in adults, children, and infants who received probiotic supplements.,,, Land et al recently reported LGG probiotic sepsis occurring in immunocompromised infants and children. A medically fragile infant 6 weeks of age became septic with a strain of LGG that was being provided as a supplement. Molecular DNA-fingerprinting confirmed that the LGG probiotic supplement was the bacterial isolate from the infant. Neonatal sepsis and meningitis that were apparently associated with the administration of a probiotic supplement were also reported.,
The apparent safety to date of adding prebiotics to infant formula has been evaluated in the previously discussed RCTs reported by Boehm et al, Moro et al, Schmelzle et al, and Bettler and Euler.
Prevention And Treatment Of Allergy
A 2007 Cochrane review concluded that there was inconclusive evidence for giving prebiotics to prevent allergic disorders in infants. However, in 2008, Arslanoglu et al reported on a 2-year follow-up of an RCT in 132 infants at risk of atopy because of parental atopy. Infants were fed a partially hydrolyzed formula with either an added mixture of FOS and GOS or maltodextrin placebo in the first 6 months of life. Those given the prebiotic mixture of FOS and GOS had a reduced incidence of atopic disease. Cumulative incidences of atopic eczema, recurrent wheezing, and allergic urticaria were higher in the maltodextrin placebo group than in the intervention group . In a 2009 review, van der Aa et al analyzed relevant publications to date and concluded that there is presently not enough evidence to support the use of probiotics, prebiotics, or synbiotics for the prevention or treatment of allergic dermatitis in children. Confirmatory studies of the benefits of prebiotics, especially for children fed formula that is not partially hydrolyzed or infants fed partially hydrolyzed formula, which are already being promoted to reduce the incidence of atopic disease, are needed before any recommendations can be made for the use of prebiotics in infants and toddlers to prevent infection or atopic disease.
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Probiotics For Prevention Of Severe Necrotizing Enterocolitis: Experience Of New Zealand Neonatal Intensive Care Units
- 1Neonatal Unit, KidzFirst, Middlemore Hospital, Auckland, New Zealand
- 2Department of Paediatrics: Child and Youth Health, University of Auckland, Auckland, New Zealand
- 3Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia
- 4Neonatal Unit, Auckland City Hospital, Auckland, New Zealand
- 5Neonatal Unit, Waikato Hospital, Hamilton, New Zealand
- 6Paediatrics, Dunedin Hospital, Dunedin, New Zealand
- 7Neonatal Unit, Christchurch Women’s Hospital, Christchurch, New Zealand
- 8Neonatal Unit, Wellington Hospital, Wellington, New Zealand
Introduction: Necrotizing enterocolitis affects mainly preterm infants, has a multifactorial etiology and is associated with intestinal dysbiosis and disordered immunity. Use of probiotics for prophylaxis is beneficial with studies indicating reduction in NEC stage 2, late onset sepsis and mortality. However, not all studies have shown a reduction, there are questions regarding which probiotic to use, whether infants < 1,000 g benefit and the risk of probiotic sepsis. All neonatal intensive care units in New Zealand use probiotics and contribute to an international database .
Objective: To use ANZNN data to investigate the experience of NZ neonatal units with probiotics for NEC prevention in a setting where the baseline incidence of severe NEC was low, to compare results of 2 commonly used probiotic regimes and report on the extremely low birth weight subgroup.
Supplementation In The Presence Of Potentially Compromised Gut Integrity
The risk of probiotic translocation and sepsis is higher in critically ill and/or extremely preterm neonates with potentially compromised gut integrity , and may be higher in the presence of high doses of a single strain. The current evidence is inadequate to make clear recommendations in this area . Investigators reported increased mortality in recipients of probiotic in an RCT involving adults with acute pancreatitis . These findings may relate to non-occlusive mesenteric ischemia in critical illness, which is exacerbated by the added bacterial load itself or a pro-inflammatory response by gut epithelial cells . Extrapolating these findings to critically ill and/or extremely preterm neonates may not be appropriate, but stopping the supplementation during an acute illness may be in the best interest of the child, pending further evidence . Studies are needed to identify the optimal use of probiotics in such neonates.
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Probiotics To Prevent Infantile Colic
What was the aim of this review?
The aim of this review was to investigate if probiotics given to healthy babies prevent infantile colic, and if they are safe.
Key messages
Although probiotics make little or no difference to the occurrence of infantile colic, they may reduce crying time and there were no safety concerns. We still require more research to work out if the onset of colic can be reduced.
What did the review study?
Infantile colic affects a large number of infants and their families worldwide. Infantile colic is a problem characterised by episodes of inconsolable crying lasting for longer than three hours per day, for more than three days a week, for at least three weeks.
Probiotics are live bacteria that, when ingested, can be beneficial for patients. Probiotics are cheap and readily available, and there is recent research investigating their use for this problem.
What were the main results of the review?
This review included six studies. The infants in the probiotics group were given different types of probiotics, and in different doses, and compared to infants who were given a placebo .
The review found that, compared to placebo, probiotics made little or no difference to the occurrence of infantile colic, but appeared to reduce crying time. There was no difference in the reporting of side effects, with only four serious events reported in one large study, and these were clinically unlikely to be linked to the taking of either of the study products.
Study Selection And Data Extraction
We included randomised controlled trials that compared probiotics to placebo, control, or other forms of treatment in mothers during the antenatal period, and term and preterm infants in the postnatal period for the prevention and treatment of infant regurgitation. Articles in any language were considered if there was an abstract in English.
We used the data extraction form available within Review Manager software to extract data on the participants, interventions and control, and outcomes of each included trial. Two review authors screened the title and abstract of all identified studies. The titles were also checked by third author . We reassessed the full text of any potentially eligible reports and excluded the studies that did not meet all the inclusion criteria. Two review authors independently extracted data from each study without blinding to authorship or journal publication. In case of any disagreement, the three review authors resolved them by discussion until reaching a consensus. One review author entered data into RevMan, and two review authors verified them .
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Accessing Probiotic Products For Research Versus Routine Use
Accessing a probiotic product 2) may be relatively easy in research rather than routine use, at least until the regulatory issues are clarified. In Australia, importing a probiotic is possible with clinical trial notification approval from the TGA and a licence to import a biological product from the Australian Quarantine and Inspection Services. It is also possible in Australia, with the local approval of the Drug and Therapeutics Committee and endorsement by the TGA of named clinicians as authorised prescribers, to obtain a probiotic under a special access scheme. A similar scheme is possible in the UK. For a new product or strain, a very thorough independent QA/QC process is needed before using it in this high-risk population. Small placebo-controlled trials will be important to rigorously assess and confirm the ability of the new strains to colonise the preterm gut if the product is to be adopted for routine use. Even minor variations in the manufacturing process can compromise the safety and efficacy of the product .
Pros And Cons Of Administration Of Currently Available Probiotic Products
NEC remains a devastating disease in preterm infants, with high mortality and morbidity. Given the number of publications in favor of using probiotics for the prevention of NEC, it is not at all surprising that the use of probiotics is increasing, even with the inherent limitations of dietary supplementgrade products that are currently available in the United States. A recent series of articles has eloquently outlined the pros and cons of routine usage of currently available probiotic products,, and other groups have also urged caution before implementation of routine use of probiotics.
Some of the products currently available in the United States include Culturelle , Similac Probiotic Tri-Blend , and Evivo . Each of these preparations are categorized as dietary supplements and are not labeled with the number of CFUs for the probiotic strain.
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Effect Of Different Species Of Probiotics
Severe NEC: Species of Probiotics
Evidence from RCTs. The administration of Lactobacillus GG and Bifidobacterium lactis species alone significantly reduced the incidence of severe stage II-III NEC . The pooled effect of the included trials that utilized L. reuteri , B. breve and Saccharomyces boulardii alone showed a lack of significant reduction of severe NEC stage II-III . Subgroup analysis identified that mixtures of 2 types and mixtures of more than 2 types of probiotics were most beneficial in reducing the risk of NEC .
Evidence from Observational Studies. The administration of L. reuteri showed a significant reduction of the risk rate of NEC . There was no significant difference in NEC risk between the probiotic group and the control group for the infants receiving B. breve or Lactobacillus GG . Analysing the different strains, the use of a 2-probiotic combination proved to be statistically significant in reducing NEC when compared to other probiotic combinations .
Late-Onset Sepsis: Species of Probiotics
Evidence from RCTs. The administration of single-strain L. reuteri, Lactobacillus GG, B. lactis, B. breve, S. boulardii alone or a mixture of 2 types of probiotics or more did not reduce the incidence of culture-proven sepsis significantly .
Mortality: Species of Probiotics
Evidence from Observational Studies. The administration of B. breve alone or a mixture of probiotics significantly reduced the incidence of mortality .
Probiotics In Vlbw Infants
Effects of Probiotics on Severe NEC
Evidence from RCTs. Twenty-nine trials reported data on NEC in VLBW infants. The administration of probiotics significantly reduced the incidence of severe NEC . There was no evidence of significant publication bias by inspection of the funnel plot and formal statistical tests .
Fig. 1
Effects of probiotics on severe NEC in RCT studies.
Evidence from Observational Studies. Fourteen studies reported on severe stage II-III NEC. The administration of probiotics significantly reduced the incidence of severe stage II-III NEC in VLBW infants . There was no evidence of significant publication bias by inspection of the funnel plot and formal statistical tests .
Fig. 2
Effects of probiotics on severe NEC in observational studies.
Effects of Probiotics on Late-Onset Sepsis
Evidence from RCTs. Twenty-eight trials reported on late-onset sepsis. The administration of probiotics reduced the rate of sepsis in the pooled effect by 12% . There was no evidence of significant publication bias by inspection of the funnel plot and formal statistical tests .
Fig. 3
Effects of probiotics on late-onset sepsis in RCT studies.
Evidence from Observational Studies. Eight studies reported on late-onset sepsis. The administration of probiotics reduced the incidence of sepsis in VLBW infants by 19% . There was no evidence of significant publication bias by inspection of the funnel plot and formal statistical tests .
Fig. 4
Effects of Probiotics on Mortality
Fig. 5
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