scholarly journals Effectiveness of an antenatal maternal supplementation with prebiotics for preventing atopic dermatitis in high-risk children (the PREGRALL study): protocol for a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. e024974 ◽  
Author(s):  
Clémentine Cabridain ◽  
Hélène Aubert ◽  
Bertrand Kaeffer ◽  
Virginie Badon ◽  
Marion Boivin ◽  
...  
Keyword(s):  
At Risk ◽  
Atopic Dermatitis ◽  
High Risk ◽  
Controlled Trial ◽  
Working Party ◽  
University Hospital ◽  
Ethical Review ◽  
Double Blind ◽  
Maternal Supplementation ◽  
High Risk Children

IntroductionAtopic dermatitis (AD) is a chronic inflammatory disease affecting 10%–15% of children in Europe. There is a need for new primary preventive therapeutic strategies in at-risk populations. Recent research has indicated that atopic diseases are associated with a disrupted gut microbial ‘balance’ in early life raising the possibility that interventions which yield optimal patterns of microflora could improve host’s health. Prebiotics, sugars with immunomodulatory properties that stimulate the diversity of the digestive microbiota, are ideal candidates for such research. So far, most clinical trials have focused on improving infant gut colonisation postnatally. However, prenatal life is a crucial period during which different tolerance mechanisms are put in place. We aim to determine whether antenatal prebiotics supplementation prevents AD in high-risk children.Methods and analysisThis is a randomised, multicentre, double-blind, trial to evaluate the effectiveness of antenatal prebiotic maternal supplementation (galacto-oligosaccharide/inulin) in pregnant women versus placebo on the occurrence of AD at 1 year of age in at-risk children (defined as having a maternal history of atopic disease). Participating women will be randomised to daily ingestion of a prebiotics or placebo (maltodextrin) from 20 weeks’ gestation until delivery. The primary outcome is the prevalence of AD at 1 year of age, using the version of the UK Working Party Diagnostic Criteria optimised for preventive studies. Key secondary endpoints are AD severity, quality of life and prebiotics tolerance. The target sample size is 376 women (188 patients per group) which will provide 80% power to detect a 33% reduction of the risk of AD in the verum group (α=0.05). The primary analysis will be based on the intention-to-treat principle.Ethics and disseminationResults will be presented in peer-reviewed journals and at international conferences. Ethics approval for the study was obtained from the institutional ethical review board of ‘Comité de Protection des Personnes Sud Ouest—Outre-Mer III’ of the University Hospital Centre of Bordeaux (2017/13).Trial registration numberNCT03183440; Pre-results.

scholarly journals Atorvastatin is unlikely to prevent rheumatoid arthritis in high risk individuals: results from the prematurely stopped STAtins to Prevent Rheumatoid Arthritis (STAPRA) trial

RMD Open ◽  
2021 ◽  
Vol 7 (1) ◽  
pp. e001591
Author(s):  
Laurette van Boheemen ◽  
Samina Turk ◽  
Marian van Beers-Tas ◽  
Wouter Bos ◽  
Diane Marsman ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
High Risk ◽  
Cox Regression ◽  
Controlled Trial ◽  
Pharmacological Intervention ◽  
Trial Participation ◽  
Double Blind ◽  
Cox Regression Analysis ◽  
Atorvastatin Group ◽  
Clinical Arthritis

ObjectivesPersons at high risk of rheumatoid arthritis (RA) might benefit from a low-risk pharmacological intervention aimed at primary prevention. Previous studies demonstrated disease-modifying effects of statins in patients with RA as well as an association between statin use and a decreased risk of RA development. A randomised, double-blind, placebo-controlled trial investigated whether atorvastatin could prevent arthritis development in high-risk individuals.MethodsArthralgia patients with anticitrullinated protein antibody (ACPA) >3 xULN or ACPA and rheumatoid factor, without (a history of) arthritis, were randomised to receive atorvastatin 40 mg daily or placebo for 3 years. The calculated sample size was 220 participants. The primary endpoint was clinical arthritis. Cox regression analysis was used to determine the effect of atorvastatin on arthritis development.ResultsDue to a low inclusion rate, mainly because of an unwillingness to participate, the trial was prematurely stopped. Data of the 62 randomised individuals were analysed. Median follow-up was 14 (inner quartiles 6–35) months. Fifteen individuals (24%) developed arthritis: 9/31 (29%) in the atorvastatin group; 6/31 (19%) in the placebo group: HR 1.40, 95% CI 0.50 to 3.95.ConclusionsIn this small set of randomised high-risk individuals, we did not demonstrate a protective effect of atorvastatin on arthritis development. The main reason for the low inclusion was unwillingness to participate; this may also impede other RA prevention trials. Further research to investigate and solve barriers for prevention trial participation is needed.

scholarly journals Acute Effects of Triiodothyronine on Endothelial Function in Human Subjects

2007 ◽  
Vol 92 (1) ◽  
pp. 250-254 ◽  
Author(s):  
Raffaele Napoli ◽  
Vincenzo Guardasole ◽  
Valentina Angelini ◽  
Emanuela Zarra ◽  
Daniela Terracciano ◽  
...  
Keyword(s):  
Endothelial Function ◽  
Dose Response ◽  
Vascular Reactivity ◽  
Controlled Trial ◽  
University Hospital ◽  
Acute Effects ◽  
Response Curves ◽  
Double Blind ◽  
Low T3 ◽  
Dose Response Curves

Abstract Context: Thyroid hormone regulates several cardiovascular functions, and low T3 levels are frequently associated with cardiovascular diseases. Whether T3 exerts any acute and direct effect on endothelial function in humans is unknown. Objective: Our objective was to clarify whether acute changes in serum T3 concentration affect endothelial function. Design, Setting, and Subjects: Ten healthy subjects (age, 24 ± 1 yr) participated in a double-blind, placebo-controlled trial at a university hospital. Interventions: T3 (or placebo) was infused for 7 h into the brachial artery to raise local T3 to levels observed in moderate hyperthyroidism. Vascular reactivity was tested by intraarterial infusion of vasoactive agents. Main Outcome Measures: We assessed changes in forearm blood flow (FBF) measured by plethysmography. Results: FBF response to the endothelium-dependent vasodilator acetylcholine was enhanced by T3 (P = 0.002 for the interaction between T3 and acetylcholine). The slopes of the dose-response curves were 0.41 ± 0.06 and 0.23 ± 0.04 ml/dl·min/μg in the T3 and placebo study, respectively (P = 0.03). T3 infusion had no effect on the FBF response to sodium nitroprusside. T3 potentiated the vasoconstrictor response to norepinephrine (P = 0.006 for the interaction). Also, the slopes of the dose-response curves were affected by T3 (1.95 ± 0.77 and 3.83 ± 0.35 ml/dl·min/mg in the placebo and T3 study, respectively; P < 0.05). The increase in basal FBF induced by T3 was inhibited by NG-monomethyl-l-arginine. Conclusions: T3 exerts direct and acute effects on the resistance vessels by enhancing endothelial function and norepinephrine-induced vasoconstriction. The data may help clarify the vascular impact of the low T3 syndrome and point to potential therapeutic strategies.

scholarly journals A Three-Month Consumption of Eggs Enriched with ω-3, ω-5 and ω-7 Polyunsaturated Fatty Acids Significantly Decreases the Waist Circumference of Subjects at Risk of Developing Metabolic Syndrome: A Double-Blind Randomized Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (2) ◽  
pp. 663
Author(s):  
Monique T. Ngo Njembe ◽  
Barbara Pachikian ◽  
Irina Lobysheva ◽  
Nancy Van Overstraeten ◽  
Louis Dejonghe ◽  
...  
Keyword(s):  
Metabolic Syndrome ◽  
At Risk ◽  
Randomized Controlled Trial ◽  
Waist Circumference ◽  
Controlled Trial ◽  
Density Lipoprotein ◽  
Test Group ◽  
Double Blind ◽  
Randomized Controlled ◽  
The Metabolic Syndrome

Alpha-linolenic acid (ALA), docosahexaenoic acid (DHA), rumenic acid (RmA), and punicic acid (PunA) are claimed to influence several physiological functions including insulin sensitivity, lipid metabolism and inflammatory processes. In this double-blind randomized controlled trial, we investigated the combined effect of ALA, DHA, RmA and PunA on subjects at risk of developing metabolic syndrome. Twenty-four women and men were randomly assigned to two groups. Each day, they consumed two eggs enriched with oleic acid (control group) or enriched with ALA, DHA, RmA, and PunA (test group) for 3 months. The waist circumference decreased significantly (−3.17 cm; p < 0.001) in the test group. There were no major changes in plasma insulin and blood glucose in the two groups. The dietary treatments had no significant effect on endothelial function as measured by peripheral arterial tonometry, although erythrocyte nitrosylated hemoglobin concentrations tended to decrease. The high consumption of eggs induced significant elevations in plasma low-density lipoprotein (LDL)- and high-density lipoprotein (HDL)-cholesterol (p < 0.001), which did not result in any change in the LDL/HDL ratio in both groups. These results indicate that consumption of eggs enriched with ALA, DHA, RmA and PunA resulted in favorable changes in abdominal obesity without affecting other factors of the metabolic syndrome.

Reducing the Risk of Alcohol-Exposed Pregnancies: A Study of a Motivational Intervention in Community Settings

PEDIATRICS ◽  
2003 ◽  
Vol 111 (Supplement_1) ◽  
pp. 1131-1135
Author(s):  
Keyword(s):  
At Risk ◽  
High Risk ◽  
Alcohol Use ◽  
Contraceptive Use ◽  
Controlled Trial ◽  
Counseling Session ◽  
Community Settings ◽  
Motivational Intervention ◽  
Effective Contraception

Objectives. To test the feasibility and impact of a motivational intervention in reducing drinking and/or increasing effective contraception in women who are at risk for an alcohol-exposed pregnancy. Methods. A multisite single-arm pilot study was conducted in 6 community settings in 3 large cities. A total of 2384 women were screened for eligibility; 230 were eligible on the basis of their alcohol use and lack of contraception. Of the eligible women, 190 consented and were enrolled, and 143 (75.3%) completed the 6-month follow-up. The intervention consisted of 4 manual-guided motivational counseling sessions delivered by mental health clinicians and 1 contraceptive counseling session delivered by a family planning clinician. Outcome measures include intervention completion rates, alcohol use (frequency, quantity, and bingeing), contraceptive use and effectiveness, and risk for alcohol-exposed pregnancy. Results. Among women who completed the 6-month follow-up, 68.5% were no longer at risk of having an alcohol-exposed pregnancy; 12.6% of women who completed the program reduced drinking only; 23.1% used effective contraception only; and 32.9% reported both. Results were consistent across the 6 diverse high-risk settings. Conclusions. This study provides evidence that providing 4 sessions of motivational interviewing plus a contraception counseling session is feasible and strongly suggests that this intervention can decrease the risk of alcohol-exposed pregnancy in women in high-risk settings. Additional investigation in a randomized controlled trial is warranted.

Sign in / Sign up

Export Citation Format

Share Document