scholarly journals Protocol for an outcome assessor-blinded pilot randomised controlled trial of an ion-exchange water softener for the prevention of atopic eczema in neonates, with an embedded mechanistic study: the Softened Water for Eczema Prevention (SOFTER) trial

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e027168 ◽  
Author(s):  
Zarif K Jabbar-Lopez ◽  
Nikeeta Gurung ◽  
Danielle Greenblatt ◽  
Annette Briley ◽  
Joanne R Chalmers ◽  
...  

IntroductionAtopic eczema affects 20% of UK children, and environmental factors are important in its aetiology. Several observational studies suggest an increased risk of atopic eczema in children living in hard water areas. The Softened Water for Eczema Prevention pilot trial tests the feasibility of installing domestic ion-exchange water softeners around the time of birth to reduce the risk of atopic eczema in children with a family history of atopy. A further aim is to explore the pathophysiological mechanisms for this in an embedded mechanistic study.Methods and analysisMulticentre parallel group assessor-blinded randomised controlled pilot trial. Participants are newborn babies (n=80) living in a hard water (>250 mg/L calcium carbonate) area at risk of developing atopic eczema because of a family history of atopy. Participants will be randomised prior to birth in a 1:1 ratio. The intervention group will have an ion-exchange water softener installed prior to birth. The control group will receive their usual domestic hard water supply. Follow-up will be until 6 months of age. Data will be collected at birth (baseline), 1, 3 and 6 months of age. The main outcome is the proportion of eligible families screened who are willing and able to be randomised. Several secondary feasibility and clinical endpoints will also be evaluated, alongside mechanistic outcomes. Data will be analysed on an intention-to-treat basis. There will be no hypothesis testing for the clinical outcomes. Study acceptability will be evaluated through semistructured interviews.Ethics and disseminationThis study has been reviewed and given a favourable opinion by the North West–Liverpool East Research Ethics Committee (Ref: 17/NW/0661). The results of the study will be reported at international conferences and in peer-reviewed scientific journals. We will send participating families a summary of the pilot trial results.Trial registration numberNCT03270566.

Healthcare ◽  
2021 ◽  
Vol 9 (9) ◽  
pp. 1105
Author(s):  
Rebecca L. Haslam ◽  
Aaron Bezzina ◽  
Jaimee Herbert ◽  
Neil Spratt ◽  
Megan E. Rollo ◽  
...  

Migraine is the third most common condition worldwide and is responsible for a major clinical and economic burden. The current pilot trial investigated whether ketogenic diet therapy (KDT) is superior to an evidence-informed healthy “anti-headache” dietary pattern (AHD) in improving migraine frequency, severity and duration. A 12-week randomised controlled crossover trial consisting of the two dietary intervention periods was undertaken. Eligible participants were those with a history of migraines and who had regularly experienced episodes of moderate or mildly intense headache in the previous 4 weeks. Migraine frequency, duration and severity were assessed via self-report in the Migraine Buddy© app. Participants were asked to measure urinary ketones and side effects throughout the KDT. Twenty-six participants were enrolled, and 16 participants completed all sessions. Eleven participants completed a symptom checklist; all reported side-effects during KDT, with the most frequently reported side effect being fatigue (n = 11). All completers experienced migraine during AHD, with 14/16 experiencing migraine during KDT. Differences in migraine frequency, severity or duration between dietary intervention groups were not statistically significant. However, a clinically important trend toward lower migraine duration on KDT was noted. Further research in this area is warranted, with strategies to lower participant burden and promote adherence and retention.


Author(s):  
Z.K. Jabbar‐Lopez ◽  
B. Ezzamouri ◽  
A. Briley ◽  
D. Greenblatt ◽  
N. Gurung ◽  
...  

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e024594 ◽  
Author(s):  
Adrian Lowe ◽  
John Su ◽  
Mimi Tang ◽  
Caroline J Lodge ◽  
Melanie Matheson ◽  
...  

IntroductionThe skin is an important barrier against environmental allergens, but infants have relatively impaired skin barrier function. There is evidence that impaired skin barrier function increases the risk of allergic sensitisation, atopic dermatitis (AD) and food allergy. We hypothesise that regular prophylactic use of emollients, particularly those that are designed to improve skin barrier structure and function, will help prevent these conditions. With the aim of determining if application of a ceramide-dominant emollient two times per day reduces the risk of AD and food allergy, we have commenced a multicentre phase III, outcome assessor blinded, randomised controlled trial of this emollient applied from birth to 6 months.Methods and analysisInfants (n=760) with a family history of allergic disease will be recruited from maternity hospitals in Melbourne. The primary outcomes are as follows: the presence of AD, assessed using the UK Working Party criteria, and food allergy using food challenge, in the first 12 months of life as assessed by a blinded study outcome assessor. Secondary outcomes are as follows: food sensitisation (skin prick test), skin barrier function, AD severity, the presence of new onset AD after treatment cessation (between 6 and 12 months) and the presence of parent reported AD/eczema. Recruitment commenced in March 2018.Ethics and disseminationThe PEBBLES Study is approved by the Human Research Ethics Committees of the Royal Children’s Hospital (RCH) (#37090A) and the Mercy Hospital for Women (2018–008). Parents or guardians will provide written informed consent. Outcomes will be disseminated through peer-reviewed publications and presented at scientific conferences.Trial registration numbersACTRN12617001380381 andNCT03667651.


2016 ◽  
Vol 54 (1) ◽  
pp. 56-67
Author(s):  
Augusto Penaranda ◽  
Elizabeth Garcia ◽  
Ana M. Barragan ◽  
Martin A. Rondon ◽  
Adriana Perez ◽  
...  

Background: Several studies have shown variations in the prevalence of allergic rhinitis (AR) around the world, and different potential predisposing factors. More studies are needed on risk factors, specifically in developing countries. This study explored the association of several factors and AR among urban residents in six cities of Colombia. Methodology: A cross-sectional study and a nested case-control study were carried out between 2009 and 2010 involving two Colombian subpopulations: children/adolescents and adults. Cases were affirmative respondents to "In the past 12 months, have you (or your child) had a problem with sneezing or a running or blocked nose, when you (or your child) did not have a cold or the flu?" "Controls" were subjects who never had been diagnosed with asthma, AR or atopic eczema by a physician, and whom did not report any symptoms in the past twelve months. Weighted logistic regression was used to assess the association of different factors with case/control status. Results: Factors associated with AR in children/adolescents were family history of AR, acetaminophen consumption and high socioeconomic status. Among adults, family history of asthma, AR and atopic eczema, and cetaminophen consumption were associated with AR. Consumption of cereals among children/adolescents and eating eggs among adults showed protective associations. Conclusions: Our findings suggest the presence of previously unknown cultural, environmental and family factors associated with the presence of AR in Colombia.


1982 ◽  
Vol 25 (4) ◽  
pp. 482-486 ◽  
Author(s):  
Robin A. Seider ◽  
Keith L. Gladstien ◽  
Kenneth K. Kidd

Time of language onset and frequencies of speech and language problems were examined in stutterers and their nonstuttering siblings. These families were grouped according to six characteristics of the index stutterer: sex, recovery or persistence of stuttering, and positive or negative family history of stuttering. Stutterers and their nonstuttering same-sex siblings were found to be distributed identically in early, average, and late categories of language onset. Comparisons of six subgroups of stutterers and their respective nonstuttering siblings showed no significant differences in the number of their reported articulation problems. Stutterers who were reported to be late talkers did not differ from their nonstuttering siblings in the frequency of their articulation problems, but these two groups had significantly higher frequencies of articulation problems than did stutterers who were early or average talkers and their siblings.


2001 ◽  
Vol 120 (5) ◽  
pp. A442-A442
Author(s):  
P TSIBOURIS ◽  
M HENDRICKSE ◽  
P ISAACS

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