Probiotics Effect on Interleukin-4 (IL-4) and Imunoglobulin E (IgE) Levels on Asthmatic Patients

Introduction: Probiotics may play a role in immune system maturation and may reduce the risk of allergies and asthma in childhood. However, the therapeutic benefits of probiotics in asthma depend on various factors such as strain of probiotics and dosing regimen. Objectives: The aims of this study was to evaluate the effect of probiotic (LactoB®) on Immunoglobulin E (IgE) and Interleukin (IL-4) serum level in childhood Asthma. Methods: Forty children aged 1-5 years with asthma were recruited into a randomized controlled trial. The children were assigned into a probiotic (Lactobacillus acidophilus, Bifidobacterium longun, Streptococcus; Lacto B®) or an equivalent volume of placebo, twice daily orally for 8 weeks. The IgE and IL-4 serum level were determined by ELISA. The differences between groups were analyzed by t-test dependent with confidence interval of 95%. Results: In intervention group, mean of IgE serum levels after the probiotics treatment was significantly lower compared to that of before the treatment (148.18 pg/mg; 283.20 pg/mg; respectively). Mean of IL-4 serum levels after the treatment was significantly lower compared with that of before the treatment (111.03 pg/mg; 142.08 pg/mg respectively). In control group, there were no significant differences between IgE serum levels mean before the administration of placebo and after the intervention (292.39 pg/ml; 286.94 pg/ml respectively). There were no significant differences between IL-4 serum levels mean before and after the treatment (136.76 pg/ml; 139.56 pg/ml).Conclusion: there was an effect of probiotics supplementation on IgE and IL-4 serum levels in childhood asthma.

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Impact of supplementation with "multivitamin-mineral" specially formulated to improve fatigue and inflammatory state in patients with multiple sclerosis: A triple-blind, randomized, placebo-controlled trial

Current Journal of Neurology ◽

10.18502/cjn.v19i4.5545 ◽

2021 ◽

Author(s):

Sama Bitarafan ◽

Elmira Karimi ◽

Abdorreza Naser Moghadasi ◽

Razieh Sadat K Kazemi-Mozdabadi ◽

Zinat Mohammadpour ◽

...

Keyword(s):

Multiple Sclerosis ◽

Controlled Trial ◽

Intervention Group ◽

Complementary Therapy ◽

Interleukin 4 ◽

Control Group ◽

Fatigue Score ◽

Number Of Patients ◽

Significant Difference ◽

Inflammatory State

Background: Multiple sclerosis (MS) is an inflammatory disease of the central nervous system (CNS) with the most common complaint of fatigue. A high number of patients with MS are interested in taking dietary supplements as a complementary therapy. We propose a specially formulated supplement for patients with MS and aim to evaluate its effects on fatigue. Methods: This study was a triple-blind, randomized, placebo-controlled trial using a stratified randomization method according to sex. 46 eligible patients participated in the study, 23 in the placebo group and 23 in the intervention group. The intervention group received two capsules of multivitamin-mineral (MVM) daily for 3 months. Measurements of fatigue and cytokines were performed in all patients at the baseline and after the 3-month intervention Results: Finally, information of 41 participants was used for data analysis. However, fatigue was decreased after supplementation than before, in the intervention group (P = 0.005). There was no significant difference (P = 0.090) between the change of fatigue score in the MVM group (-3.00 ± 4.42) and the control group (-0.40 ± 5.14). Among cytokines, Interleukin 4 (IL-4) significantly increased in the intervention group compared to the placebo (P = 0.030). Conclusion: Our study showed that the present MVM probably could improve the inflammatory state and fatigue in patients with MS.

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A Mediterranean Dietary Intervention in Female Carriers of BRCA Mutations: Results from an Italian Prospective Randomized Controlled Trial

Cancers ◽

10.3390/cancers12123732 ◽

2020 ◽

Vol 12 (12) ◽

pp. 3732

Author(s):

Eleonora Bruno ◽

Andreina Oliverio ◽

Angelo Virgilio Paradiso ◽

Antonella Daniele ◽

Stefania Tommasi ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Dietary Intervention ◽

Controlled Trial ◽

Intervention Group ◽

Serum Levels ◽

Protein Restriction ◽

Control Group ◽

Brca Mutations ◽

Randomized Controlled ◽

Igf I

Background: Women carriers of BRCA1/2 mutations face a high lifetime risk (penetrance) of developing breast and/or ovarian cancer. Insulin-like growth factor I (IGF-I), body weight and markers of insulin resistance affect BRCA penetrance. We conducted a multicenter prospective two-armed (1:1) randomized controlled trial (NCT03066856) to investigate whether a Mediterranean dietary intervention with moderate protein restriction reduces IGF-I and other metabolic modulators of BRCA penetrance. Methods: BRCA carriers, with or without a previous cancer, aged 18–70 years and without metastases were randomly assigned to an active dietary intervention group (IG) or to a control group (CG). The primary endpoint of the intervention was the IGF-I reduction. Results: 416 women (216 in the IG and 200 in the CG) concluded the six-month dietary intervention. The IG showed significantly lowered serum levels of IGF-I (−11.3 ng/mL versus −1.3 ng/mL, p = 0.02), weight (−1.5 Kg versus −0.5 Kg, p < 0.001), waist circumference (−2 cm versus −0.7 cm, p = 0.01), hip circumference (−1.6 cm versus −0.5 cm, p = 0.01), total cholesterol (−10.2 mg/dL versus −3.6 mg/dL, p = 0.04) and triglycerides (−8.7 mg/dL versus + 5.5 mg/dL, p = 0.01) with respect to the CG. Conclusions: A Mediterranean dietary intervention with moderate protein restriction is effective in reducing IGF-I and other potential modulators of BRCA penetrance.

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Vitamin D Variants Levels Exposed and Association With the Disease Severity in Bronchial Asthma

10.21203/rs.3.rs-35942/v1 ◽

2020 ◽

Author(s):

Sultan S Al-Thagfan ◽

Sameh Ahmed ◽

Magdy M Emara ◽

Mohamed Fawzi Awadallah

Keyword(s):

Vitamin D ◽

Disease Activity ◽

Disease Severity ◽

Bronchial Asthma ◽

Blood Count ◽

Immunoglobulin E ◽

Serum Levels ◽

Control Group ◽

Mass System ◽

Asthmatic Patients

Abstract Background: Several vitamin D variants may be involved in immunity modulation including; vitamin D2 (D2), vitamin D3 (D3), 25-hydroxyvitamin D3 (25(OH) D3) and 1,25-dihydroxyvitamin D3 (1,25-(OH)2D3). The objective of this study is to assess serum levels of vitamin D variants in bronchial asthma patients and their correlations with disease activity markers.Methods: 113 persons divided into two groups were enrolled in this study. The first group included 73 asthmatic patients (57 males and 16 females) and the second included 40 healthy adult (31 male and 9 female) as a control group. Vitamin D variants serum levels were assessed using ultra performance liquid chromatography (UPLC) with tandem mass system. Different disease activity markers were assessed and correlated with serum levels of vitamin D variants. These markers included forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), FEV1/FVC% , peak expiratory flow (PEF), forced expiratory flow25–75% (FEF25-75%), eosinophilic blood count, and total immunoglobulin E (IgE), Results: The study showed that asthmatic patients had significant lower serum levels of vitamin D variants in comparison with the healthy control group (p ≤ 0.001). Also, serum vitamin D variants levels were significantly decreased in uncontrolled asthmatic patients as compared with the partially controlled and controlled patients. The correlation values were higher for 25(OH) D3 and 1,25-(OH) 2D3 compared to D2 and D3. Negative correlations were seen for eosinophilic blood count, total IgE and ACT.Conclusion: Serum levels of all vitamin D variants were reduced in asthmatic patients with moderate to strong correlations to the disease severity. These results suggest that vitamin D deficiency or even insufficiency may play a role in disease severity.

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"The effect of Exercise during hemodialysis on serum levels of Albumin, calcium, phosphorus and parathyroid hormone: a randomized clinical trial"

10.21203/rs.3.rs-446114/v1 ◽

2021 ◽

Author(s):

Alireza Dashtidehkordi ◽

Nahid Shahgholian ◽

Jaleh Sadeghian

Keyword(s):

Parathyroid Hormone ◽

Controlled Trial ◽

Intervention Group ◽

Exercise Program ◽

Serum Levels ◽

Electrolyte Imbalance ◽

Control Group ◽

Significant Difference ◽

Calcium Phosphorus ◽

The Impact

Abstract Background: Chronic kidney disease is often accompanied by disturbances in the levels of serum electrolytes. Because of electrolyte imbalance and other factors, the patients experience some of the systemic symptoms and physical and mental dysfunction. We aimed determine the impact of exercise during hemodialysis on serum levels of Albumin, calcium, phosphorus and parathyroid hormone. Methods: In a randomized controlled trial in hemodialysis units of Iran’s two hospital, 60 patients undergoing hemodialysis having required criteria were included and assigned into the exercise group (n = 30) and the control group (n = 30). An exercise program using stationary bicycles were done in the intervention group, 60 minutes/ every session, three times a week, for 8 weeks. The main outcome measures were the serum levels of Albumin, Calcium, Phosphate, and Parathyroid hormone. Results: The independent t-test results showed no significant difference between the mean serum levels of Albumin, Calcium, Phosphorus and Parathyroid hormone before the intervention (P > 0.05). However, after an eight-week intervention, significant improvements were seen in serum phosphate levels and Parathyroid hormone (P=0.04), while the serum levels of Albumin (P=0.3) and calcium (P = 0. 5) did not change significantly in the intervention group. Conclusions: An exercise program by stationary bicycles is a safe, effective and complementary clinical intervention in patients with ESRD on hemodialysis.

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Promoting the Community's Ability to Detect and Respond to Suicide Risk Through an Online Bystander Intervention Model-Informed Tool

Crisis ◽

10.1027/0227-5910/a000708 ◽

2020 ◽

pp. 1-7

Author(s):

Karien Hill ◽

Shawn Somerset ◽

Ralf Schwarzer ◽

Carina Chan

Keyword(s):

Suicide Prevention ◽

Suicide Risk ◽

Controlled Trial ◽

Intervention Group ◽

Bystander Intervention ◽

Self Report ◽

Innovative Technology ◽

Control Group ◽

Intervention Model ◽

Standard Material

Abstract. Background: The public health sector has advocated for more innovative, technology-based, suicide prevention education for the community, to improve their ability to detect and respond to suicide risk. Emerging evidence suggests addressing the bystander effect through the Bystander Intervention Model (BIM) in education material may have potential for suicide prevention. Aims: The current study aimed to assess whether BIM-informed tools can lead to improved readiness, confidence and intent in the community to detect and respond to suicide risk in others. Method: A sample of 281 adults recruited from the community participated in a randomized controlled trial comprising a factsheet designed according to the BIM (intervention group) and a standard factsheet about suicide and mental health (control group). Participants' self-reported detecting and responding to suicide risk readiness, confidence, and intent when presented with a suicidal peer was tested pre- and postintervention and compared across time and between groups. Results: The intervention group had significantly higher levels of detecting and responding to suicide risk readiness, confidence, and intent than the control group at postintervention (all p < .001) with moderate-to-large effect sizes. Limitations: The study was limited by a homogenous sample, too low numbers at follow-up to report, and self-report data only. Conclusion: This study demonstrates BIM-informed suicide prevention training may enhance the community's intervention readiness, confidence, and intent better than current standard material. Further testing in this area is recommended. While results were statistically significant, clinical significance requires further exploration.

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Breastfeeding Training through Role-Play and Effects on Mother-infant Attachment Behaviours: A Randomised Controlled Trial

Africa Journal of Nursing and Midwifery ◽

10.25159/2520-5293/6232 ◽

2020 ◽

Vol 22 (1) ◽

Author(s):

Farokh Saljughi ◽

Mitra Savabi-Esfahani ◽

Shahnaz Kohan ◽

Soheila Ehsanpour

Keyword(s):

Pregnant Women ◽

Maternal Employment ◽

Controlled Trial ◽

Role Play ◽

Intervention Group ◽

Control Group ◽

Maternal Behaviour ◽

Infant Attachment ◽

Significant Difference ◽

History Of

Mother-infant attachment is an intimate, lasting and satisfying relationship that leads to better cognitive, emotional and social growth of the infant. The aim of this study was to determine the effects of breastfeeding training by role-play on mother-infant attachment behaviours. This research was a randomised clinical trial (parallel design). Inclusion criteria were: no history of mental disorders; ability to read and write the Persian language to complete the questionnaire; no history of drug and tobacco intake in primigravida women. The sample comprised 100 pregnant women (in 2 groups), selected through simple random sampling at healthcare centres. The researcher reviewed prenatal care registries of selected healthcare centres and extracted the names of pregnant women in their early third trimester. The data were imported into randomisation software. The control group received routine breastfeeding training, while the intervention group received routine training together with training through role-play. The data collection tool was the Maternal Behaviour Inventory Questionnaire. Consequently 75 samples were analysed in SPSS16. Independent t-tests and chi-square tests were used to examine the difference between the two groups. Results showed that the mean score of mother-infant attachment one week after delivery was significantly higher in the intervention group in comparison to that in the control group (p<0.001). No significant difference was observed between the two groups in maternal age, age of marriage, neonatal gender, maternal employment and education, number of parity, and number of abortions (P>0.05). Since breastfeeding training through role-play could affect mother-infant attachment, it is suggested that this type of training should be provided for pregnant women to promote mother-infant attachment and exclusive breastfeeding.

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The Effect of Reflexology on Labor Pain and Length Among Primiparous Women: A Randomized Controlled Trial

International Electronic Journal of Medicine ◽

10.31661/iejm805 ◽

2018 ◽

Vol 7 ◽

Author(s):

Azita Kamjoo

Keyword(s):

Controlled Trial ◽

Intervention Group ◽

Active Phase ◽

Labor Pain ◽

Control Group ◽

Singleton Pregnancy ◽

Group Data ◽

Significant Difference ◽

Labor Length ◽

Primiparous Women

Background: Pain control is considered as the key issue in modern midwifery. Along with medical painkillers, reflexology is viewed as a non-medical and noninvasive method. Hence, we aimed to investigate the effect of reflexology on the intensity of pain and length of labor. Materials and Methods: In this clinical trial, participants included 240 Iranian primiparous women with term and singleton pregnancy. Having a 3-4 cm cervical dilatation once they visited the hospital. Through a convenient sampling method, they were selected and then randomly divided into two groups. In the intervention group, reflexology was performed, and the intensity of pain during the active phase of labor along with the length of labor in the active phase was measured by visual analog scale (VAS) and compared with the control group. Data were analyzed using descriptive statistics, t-test, and Mann-Whitney U-test. Result: Data analysis showed a statistically significant difference between the intensity of pain in the 5-7 and 8-10 cm dilatation in the two groups (P=0.01). Moreover, the labor length in the active phase was found to be significantly shorter in the intervention group (P<0.001). Conclusion: It appears that reflexology can lead to a reduction in the pain and length of labor. Therefore, through instructing this technique, a goal of midwifery, which is reducing labor pain and its length can be achieved. Keywords: Reflexology, Labor Pain, Labor Length, Primiparous Women

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Effect of Dietary Education on Cardiovascular risk Factors in Rheumatoid Arthritis Patients

Current Rheumatology Reviews ◽

10.2174/1573397116666200907112338 ◽

2020 ◽

Vol 16 ◽

Author(s):

Rahil Taheri ◽

Shahram Molavynejad ◽

Parvin Abedi ◽

Elham Rajaei ◽

Mohammad Hosein Haghighizadeh

Keyword(s):

Rheumatoid Arthritis ◽

Risk Factors ◽

Blood Pressure ◽

Cardiovascular Risk ◽

Cardiovascular Risk Factors ◽

Statistical Tests ◽

Intervention Group ◽

Serum Levels ◽

Control Group ◽

Dietary Education

Aim: The aim of this study was to investigate the effect of dietary education on cardiovascular risk factors in patients with rheumatoid arthritis. Method: In this randomized clinical trial, 112 patients with rheumatoid arthritis were randomly assigned into two groups, intervention and control. Dietary education was provided for the intervention group in 4 sessions; anthropometric measurements, serum levels of RF, triglycerides, cholesterol, HDL, LDL, and fasting blood sugar were measured before and three months after intervention. Data was analyzed using SPSS software and appropriate statistical tests. Results: The mean of total cholesterol (p <0.001), triglycerides (p = 0.004), LDL (p <0.001), systolic blood pressure (p = 0.001), diastolic blood pressure (p = 0.003), FBS and BMI (p <0.001) were decreased significantly in the intervention group after education compared the control group. Conclusion: Traditional care for rheumatoid arthritis patients is not enough. Patients need more education in order to improve their situation.

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Effectiveness of an Educational Intervention in Reducing New International Postgraduates’ Acculturative Stress in Malaysian Public Universities: Protocol for a Cluster Randomized Controlled Trial (Preprint)

10.2196/preprints.12950 ◽

2018 ◽

Author(s):

Musheer Abdulwahid Al-Jaberi ◽

Muhamad Hanafiah Juni ◽

Hayati Kadir Shahar ◽

Siti Irma Fadhilah Ismail ◽

Murad Abdu Saeed ◽

...

Keyword(s):

International Students ◽

Acculturative Stress ◽

Educational Program ◽

Public Universities ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Policy Makers ◽

Randomized Controlled ◽

Cluster Randomized

BACKGROUND Universities around the world, including Malaysia, have attracted many international students from different countries. Research has reported that acculturative stress resulting from international students’ attempts to adjust to the cultures of host countries is one of the most challenging issues that affects their lives in general and academic lives in particular. OBJECTIVE This study aims to examine the effectiveness of an educational intervention on acculturative stress among new postgraduate international students joining Malaysian public universities. METHODS A cluster randomized controlled trial design with Malaysian public universities as the unit of randomization will be used in this study. Public universities will be randomized in a 1:1 ratio to be either in the intervention (educational program) or control group (waiting list). Participants in the intervention group will receive 7 sessions in 9 hours delivered by an expert in psychology and the researcher. The control group will receive the intervention once the 3-month follow-up evaluation is completed. RESULTS The data will be analyzed using the generalized estimation equation with a confidence interval value of 95%; significant differences between and within groups are determined as <i>P</i><.05. The results of the study underlie the effectiveness of educational program in decreasing acculturative stress of new international students and enabling them to cope with a new environment. The results of this study will contribute to previous knowledge of acculturative stress, acculturation, and adjustment of international students. Furthermore, such results are expected to play a role in raising university policy makers’ awareness of their postgraduate international students’ acculturative stress issues and how they can help them avoid such stress and perform well in their academic life. CONCLUSIONS We expect that the intervention group will score significantly lower than the wait-list group on the immediate and 3-month postintervention evaluation of acculturative stress and achieve a higher level of adjustment. Results will have implications for international students, policy makers at universities, the Malaysian Ministry of Higher Education, and future research. CLINICALTRIAL Clinical Trials Registry India CTRI/2018/01/011223; http://ctri.nic.in/Clinicaltrials/showallp.php?mid1= 21978&amp;EncHid=&amp;userName=Muhamad%20Hanafiah%20Juni INTERNATIONAL REGISTERED REPORT PRR1-10.2196/12950

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Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

10.2196/preprints.16141 ◽

2019 ◽

Author(s):

Jan van Lieshout ◽

Joyca Lacroix ◽

Aart van Halteren ◽

Martina Teichert

Keyword(s):

Randomized Controlled Trial ◽

Medication Adherence ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Community Pharmacies ◽

Web Based ◽

Randomized Controlled ◽

Tailored Interventions ◽

Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

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