Medical Specialties Commons^™

Diabetes Conflict Outstrips The Positive Impact Of Self-Efficacy On Youth Adherence And Glycemic Control In Type 1 Diabetes., Amy E. Noser, Lindsay Huffhines, Mark A. Clements, Susana R. Patton

Manuscripts, Articles, Book Chapters and Other Papers

Objective: To examine whether self-efficacy buffers the deleterious consequences of diabetes-specific family conflict on self-monitoring blood glucose (SMBG) and glycated hemoglobin (HbA1c) in youth with type 1 diabetes mellitus (T1DM).

Methods: A total of 129 youth with T1DM (aged 10-16 years) completed measures of diabetes-specific family conflict and self-efficacy for diabetes management, and their blood glucose meter data and HbA1c were extracted from the electronic medical record. We preformed moderation analyses to examine whether self-efficacy moderated the association that diabetes-specific family conflict had with SMBG and HbA1c. We used simple slopes analyses to probe significant interactions.

Results: Our results indicated …

Comparative Trial Between Neonatal Intensive Care Incubator, Neonatal Laminar Flow And Radiant Warmer, J Perez, F Perez, Sergio Golombek, Augusto Sola

NYMC Faculty Publications

No abstract provided.

Modifiers Of The Effect Of Maternal Multiple Micronutrient Supplementation On Stillbirth, Birth Outcomes, And Infant Mortality: A Meta-Analysis Of Individual Patient Data From 17 Randomised Trials In Low-Income And Middle-Income Countries, Emily R. Smith, Anuraj H. Shankar, Lee S-F Wu, Said Aboud, Seth Adu Afarwuah, Hasmot Ali, Rina Agustina, Shams Arifeen, Per Ashorn, Arjumand Rizvi

Department of Paediatrics and Child Health

Background: Micronutrient deficiencies are common among women in low-income and middle-income countries. Data from randomised trials suggest that maternal multiple micronutrient supplementation decreases the risk of low birthweight and potentially improves other infant health outcomes. However, heterogeneity across studies suggests influence from effect modifiers. We aimed to identify individual-level modifiers of the effect of multiple micronutrient supplements on stillbirth, birth outcomes, and infant mortality in low-income and middle-income countries.
Methods: This two-stage meta-analysis of individual patient included data from 17 randomised controlled trials done in 14 low-income and middle-income countries, which compared multiple micronutrient supplements containing iron-folic acid versus iron-folic …

Geo-Spatial Reporting For Monitoring Of Household Immunization Coverage Through Mobile Phones: Findings From A Feasibility Study, Abdul Momin Kazi, M. Ali, Ayub Khan, Hussain Kalimuddin, K. Zubair, A.N. Kazi, Azmina Artani, Syed Asad Ali

Department of Paediatrics and Child Health

Background: The addition of Global Positioning System (GPS) to a mobile phone makes it a very powerful tool for surveillance and monitoring coverage of health programs. This technology enables transfer of data directly into computer applications and cross-references to Geographic Information Systems (GIS) maps, which enhances assessment of coverage and trends.
Objective: Utilization of these systems in low and middle income countries is currently limited, particularly for immunization coverageassessments and polio vaccination campaigns. We piloted the use of this system and discussed its potential to improve the efficiency of field-based health providers and health managers for monitoring of the immunization …

Concordance Of Cerebrospinal Fluid Latex Particle Agglutination Test With Csf And Blood Culture Among Children With Acute Bacterial Meningitis, Muhammad Khalid, Ali Faisal Saleem

Department of Paediatrics and Child Health

No abstract provided.

Hyperoxia Causes Mir-34a-Mediated Injury Via Angiopoietin-1 In Neonatal Lungs., Mansoor Syed, Pragnya Das, Aishwarya Pawar, Zubair H. Aghai, Anu Kaskinen, Zhen W. Zhuang, Namasivayam Ambalavanan, Gloria Pryhuber, Sture Andersson, Vineet Bhandari

Department of Pediatrics Faculty Papers

Hyperoxia-induced acute lung injury (HALI) is a key contributor to the pathogenesis of bronchopulmonary dysplasia (BPD) in neonates, for which no specific preventive or therapeutic agent is available. Here we show that lung micro-RNA (miR)-34a levels are significantly increased in lungs of neonatal mice exposed to hyperoxia. Deletion or inhibition of miR-34a improves the pulmonary phenotype and BPD-associated pulmonary arterial hypertension (PAH) in BPD mouse models, which, conversely, is worsened by miR-34a overexpression. Administration of angiopoietin-1, which is one of the downstream targets of miR34a, is able to ameliorate the BPD pulmonary and PAH phenotypes. Using three independent cohorts of …

Legionellosis Following Water Birth In A Hot Tub In A Canadian Neonate, Michelle Barton, Brianna Mckelvie, Aaron Campigotto, Tara Mullowney

Paediatrics Publications

No abstract provided.

Pediatric Residency Training And Behavioral Health: Models And Outcomes, Jeffrey D. Shahidullah Phd, Paul W. Kettlewell Phd, Mohammed Palejwala Ma, Kathryn A. Dehart Md, Kris Rooney Md, Laura Diaz Md, Joanna Carlson Md

Department of Pediatrics

No abstract provided.

Characterization Of Pulmonary Metastases In Children With Hepatoblastoma Treated On Children's Oncology Group Protocol Ahep0731 (The Treatment Of Children With All Stages Of Hepatoblastoma): A Report From The Children's Oncology Group., Allison F. O'Neill, Alexander J. Towbin, Mark D. Krailo, Caihong Xia, Yun Gao, M. Beth Mccarville, Rebecka L. Meyers, Eugene D. Mcgahren, Greg M. Tiao, Stephen P. Dunn, Max R. Langham, Christopher B. Weldon, Milton J. Finegold, Sarangarajan Ranganathan, Wayne L. Furman, Marcio Malogolowkin, Carlos Rodriguez-Galindo, Howard M. Katzenstein

Department of Pediatrics Faculty Papers

Purpose To determine whether the pattern of lung nodules in children with metastatic hepatoblastoma (HB) correlates with outcome. Methods Thirty-two patients with metastatic HB were enrolled on Children's Oncology Group Protocol AHEP0731 and treated with vincristine and irinotecan (VI). Responders to VI received two additional cycles of VI intermixed with six cycles of cisplatin/fluorouracil/vincristine/doxorubicin (C5VD), and nonresponders received six cycles of C5VD alone. Patients were imaged after every two cycles and at the conclusion of therapy. All computed tomography scans and pathology reports were centrally reviewed, and information was collected regarding lung nodule number, size, laterality, timing of resolution, and …

Missed Immunization Opportunities Among Children Under 5 Years Of Age Dwelling In Karachi City, Asif Khaliq, Sayeeda Amber Sayed, Syed Abdullah Hussaini, Kiran Azam, Mehak Qamar

Department of Paediatrics and Child Health

Background: Immunization is the safest and effective measure for preventing and eradicating various communicable diseases. A glaring immunization gap exists between developing and industrialized countries towards immunization, because the developing countries including Pakistan are still striving to provide basic immunization to their children. The purpose of this study was to access the prevalence and factors of missing immunization among under 5-year children of Karachi.
Methods: A cross sectional study was conducted from June 2015 to October 2015 among different outpatient clinics of Karachi. Parents who had child less than 5 year of age were approached by non-probability purposive sampling. Data …

Influenza Epidemiology And Immunization During Pregnancy: Final Report Of A World Health Organization Working Group, Deshayne B. Fell, Eduardo Azziz-Baumgartner, Michael G. Baker, Maneesh Batra, Julien Beauté, Philippe Beutels, Niranjan Bhat, Zulfiqar Ahmed Bhutta, Cheryl Cohen, Rehana Salam

Department of Paediatrics and Child Health

From 2014 to 2017, the World Health Organization convened a working group to evaluate influenza disease burden and vaccine efficacy to inform estimates of maternal influenza immunization program impact. The group evaluated existing systematic reviews and relevant primary studies, and conducted four new systematic reviews. There was strong evidence that maternal influenza immunization prevented influenza illness in pregnant women and their infants, although data on severe illness prevention were lacking. The limited number of studies reporting influenza incidence in pregnant women and infants under six months had highly variable estimates and underrepresented low- and middle-income countries. The evidence that maternal …

Oral Morphine Versus Ibuprofen Administered At Home For Postoperative Orthopedic Pain In Children: A Randomized Controlled Trial, Naveen Poonai, Natasha Datoo, Samina Ali, Megan Cashin, Amy L Drendel, Rongbo Zhu, Natasha Lepore, Michael Greff, Michael Rieder, Debra Bartley

Paediatrics Publications

BACKGROUND: Oral morphine for postoperative pain after minor pediatric surgery, while increasingly popular, is not supported by evidence. We evaluated whether oral morphine was superior to ibuprofen for at-home management of children's postoperative pain.

METHODS: We conducted a randomized superiority trial comparing oral morphine (0.5 mg/kg) with ibuprofen (10 mg/kg) in children 5 to 17 years of age who had undergone minor outpatient orthopedic surgery (June 2013 to September 2016). Participants took up to 8 doses of the intervention drug every 6 hours as needed for pain at home. The primary outcome was pain, according to the Faces Pain Scale …

Adversity And Academic Performance Among Adolescent Youth: A Community-Based Participatory Research Study, Sukhdip Purewal Boparai, Tiffani Marie, Eduardo Aguayo, Jordan Brooks, Estefany Juarez, Sheana Soriano, Alasia Waters, Jaquez Donaldson, Joseph Reagans, Gracee Anguiano, Allison Ipsen

Journal of Adolescent and Family Health

Researchers and youth stakeholders devised a survey on 27 adversities based on youth expertise, clinical practice, and adversity literature. The aim of the study was to understand the prevalence of individual and cumulative adversities, and association of adversities to age, gender, race/ethnicity and academic performance among a community sample of urban high school students. All participants experienced two or more adversities and experienced greater overall adversity than youth in population-based studies. Youth-proposed stressors were among the most prevalent, and females, older youth, and African American youth reported disproportionately greater number of adversities. Specific types of adversities were endorsed differentially based …

Targeting Cysteine Thiols For In Vitro Site-Specific Glycosylation Of Recombinant Proteins, Yoo Jung Choi, Jinhui Zhu, Steve Chung, Naveed Siddiqui, Qingping Feng, Peter B. Stathopulos

Paediatrics Publications

Stromal interaction molecule-1 (STIM1) is a type-I transmembrane protein located on the endoplasmic reticulum (ER) and plasma membranes (PM). ER-resident STIM1 regulates the activity of PM Orai1 channels in a process known as store operated calcium (Ca2+) entry which is the principal Ca2+ signaling process that drives the immune response. STIM1 undergoes post-translational N-glycosylation at two luminal Asn sites within the Ca2+ sensing domain of the molecule. However, the biochemical, biophysical, and structure biological effects of N-glycosylated STIM1 were poorly understood until recently due to an inability to readily obtain high levels of homogeneous N-glycosylated protein. Here, we describe the …

Rate Of Detection Of Multiple Organisms And Clostridium Difficile With Stool Multiplex Pcr Detection Test In Pediatrics (Poster)., Saisho Mangla Do, Tibisay Villalobos Md

Department of Pediatrics

No abstract provided.

Scaffolding Proteins In The Development And Maintenance Of The Epidermal Permeability Barrier, Melissa Crawford, Lina Dagnino

Paediatrics Publications

The skin of mammals and other terrestrial vertebrates protects the organism against the external environment, preventing heat, water and electrolyte loss, as well as entry of chemicals and pathogens. Impairments in the epidermal permeability barrier function are associated with the genesis and/or progression of a variety of pathological conditions, including genetic inflammatory diseases, microbial and viral infections, and photodamage induced by UV radiation. In mammals, the outside-in epidermal permeability barrier is provided by the joint action of the outermost cornified layer, together with assembled tight junctions in granular keratinocytes found in the layers underneath. Tight junctions serve as both outside-in …

Predicting Unplanned Transfers To The Intensive Care Unit: A Machine Learning Approach Leveraging Diverse Clinical Elements, Ben Wellner, Joan Grand, Elizabeth Canzone, Matt Coarr, Patrick Brady, Nathan Dean, +Additional Authors

Pediatrics Faculty Publications

Background: Early warning scores aid in the detection of pediatric clinical deteriorations but include limited data inputs, rarely include data trends over time, and have limited validation.

Objective: Machine learning methods that make use of large numbers of predictor variables are now commonplace. This work examines how different types of predictor variables derived from the electronic health record affect the performance of predicting unplanned transfers to the intensive care unit (ICU) at three large children’s hospitals.

Methods: We trained separate models with data from three different institutions from 2011 through 2013 and evaluated models with 2014 data. Cases consisted of …

Mutations In Keops-Complex Genes Cause Nephrotic Syndrome With Primary Microcephaly, Daniela A Braun, Jia Rao, Geraldine Mollet, David Schapiro, Marie-Claire Daugeron, Weizhen Tan, Olivier Gribouval, Olivia Boyer, Patrick Revy, Tilman Jobst-Schwan, Johanna Magdalena Schmidt, Jennifer A Lawson, Denny Schanze, Shazia Ashraf, Jeremy F P Ullmann, Charlotte A Hoogstraten, Nathalie Boddaert, Bruno Collinet, Gaëlle Martin, Dominique Liger, Svjetlana Lovric, Monica Furlano, I Chiara Guerrera, Oraly Sanchez-Ferras, Jennifer F Hu, Anne-Claire Boschat, Sylvia Sanquer, Björn Menten, Sarah Vergult, Nina De Rocker, Merlin Airik, Tobias Hermle, Shirlee Shril, Eugen Widmeier, Heon Yung Gee, Won-Il Choi, Carolin E Sadowski, Werner L Pabst, Jillian K Warejko, Ankana Daga, Tamara Basta, Verena Matejas, Karin Scharmann, Sandra D Kienast, Babak Behnam, Brendan Beeson, Amber Begtrup, Malcolm Bruce, Gaik-Siew Ch'ng, Shuan-Pei Lin, Jui-Hsing Chang, Chao-Huei Chen, Megan T Cho, Patrick M Gaffney, Patrick E Gipson, Chyong-Hsin Hsu, Jameela A Kari, Yu-Yuan Ke, Cathy Kiraly-Borri, Wai-Ming Lai, Emmanuelle Lemyre, Rebecca Okashah Littlejohn, Amira Masri, Mastaneh Moghtaderi, Kazuyuki Nakamura, Fatih Ozaltin, Marleen Praet, Chitra Prasad, Agnieszka Prytula, Elizabeth R Roeder, Patrick Rump, Rhonda E Schnur, Takashi Shiihara, Manish D Sinha, Neveen A Soliman, Kenza Soulami, David A Sweetser, Wen-Hui Tsai, Jeng-Daw Tsai, Rezan Topaloglu, Udo Vester, David H Viskochil, Nithiwat Vatanavicharn, Jessica L Waxler, Klaas J Wierenga, Matthias T F Wolf, Sik-Nin Wong, Sebastian A Leidel, Gessica Truglio, Peter C Dedon, Annapurna Poduri, Shrikant Mane, Richard P Lifton, Maxime Bouchard, Peter Kannu, David Chitayat, Daniella Magen, Bert Callewaert, Herman Van Tilbeurgh, Martin Zenker, Corinne Antignac, Friedhelm Hildebrandt

Paediatrics Publications

Galloway-Mowat syndrome (GAMOS) is an autosomal-recessive disease characterized by the combination of early-onset nephrotic syndrome (SRNS) and microcephaly with brain anomalies. Here we identified recessive mutations in OSGEP, TP53RK, TPRKB, and LAGE3, genes encoding the four subunits of the KEOPS complex, in 37 individuals from 32 families with GAMOS. CRISPR-Cas9 knockout in zebrafish and mice recapitulated the human phenotype of primary microcephaly and resulted in early lethality. Knockdown of OSGEP, TP53RK, or TPRKB inhibited cell proliferation, which human mutations did not rescue. Furthermore, knockdown of these genes impaired protein translation, caused endoplasmic reticulum stress, activated DNA-damage-response signaling, and ultimately induced …

Virus-Specific T Cells For The Immunocompromised Patient, A. Houghtelin, Catherine M. Bollard

Pediatrics Faculty Publications

While progress has been made in the treatment of both hematologic cancers and solid tumors, chemorefractory or relapsed disease often portends a dismal prognosis, and salvage chemotherapy or radiation expose patients to intolerable toxicities and may not be effective. Hematopoietic stem cell transplant offers the promise of cure for many patients, and while mismatched, unrelated or haploidentical donors are increasingly available, the recipients are at higher risk of severe immunosuppression and immune dysregulation due to graft versus host disease. Viral infections remain a primary cause of severe morbidity and mortality in this patient population. Again, many therapeutic options for viral …

Oral Sildenafil Use In Neonates With Persistent Pulmonary Hypertension Of Newborn, Ali Shabbir Hussain, Syed Rehan Ali, Shakeel Ahmed, Farah Naz Qamar, Anila Haroon

Department of Paediatrics and Child Health

Background: The prevalence of PPHN has been estimated at 1.9 per 1000 live births. After the discovery of iNO's, its efficacy and benefit in PPHN is well established. Even in the best of centers equipped with iNo and ECMO the mortality is around 20%. Also, iNO is expensive and difficult to administer and monitor which makes it difficult choice in our part of the world. Furthermore About 40% of patients do not respond or have rebound pulmonary hypertension after discontinuation. Owing to these reasons, other treatment modalities like phosphodiesterase inhibitors such as Sildenafil need to be evaluated.
Methods: We report …

When The Health System Fails You: Maternal Care Under Kenya’S 2017 Nurses' Strike, Tessa Coughtrey-Davenport

Independent Study Project (ISP) Collection

This study focuses on the 2017 nurses’ strike and how the crippling of the public health system impacted maternal care in Kisumu, Kenya. Kenya has one of the highest maternal mortality ratios in the world, and there have been many efforts to reduce this, such as delivery with a Skilled Birth Attendant and attending antenatal care visits, all of which are centered around a functioning health system. The research team used a combination of interviews with key populations and analysis of service delivery data at local health centers to evaluate the effects of the strike on maternal care. The study …

Secondhand Smoke Exposure And Preclinical Markers Of Cardiovascular Risk In Toddlers, Judith A Groner, Hong Huang, Mandar S. Joshi, Nicholas Eastman, Lisa Nicholson, John Anthony Bauer

Pediatrics Faculty Publications

Objective: Links between secondhand smoke (SHS) exposure and cardiovascular disease in adults are well established but seldom reported during childhood. Although rates of smoking have decreased, young children from low-income backgrounds remain likely to be exposed to SHS. The purpose of this study was to investigate relationships between SHS exposure in young children and several preclinical markers of cardiovascular risk that have been established as relevant to adult populations.

Methods: 139 children, 2–5 years of age, were enrolled in a cross-sectional study. SHS exposure was objectively determined by hair nicotine level; a comprehensive panel of clinical markers (AM blood pressure, …

Evaluation Of Mothers And Infants With Presumed Exposure To Zika Virus: A Look Into The Lehigh Valley Experience, Tibisay Villalobos Md, Michelle Maron Rn, Jeanette Taveras Do

Department of Pediatrics

No abstract provided.

Measuring Home Environments Across Cultures: Invariance Of The Home Scale Across Eight International Sites From The Mal-Ed Study, Paul C. Jones, Laura L. Pendergast, Barbara A. Schaefer, Muneera Rasheed, Erling Svensen, Rebecca Scharf, Rita Shrestha, Angelina Maphula, Reeba Roshan, Zeba Rasmussen

Department of Paediatrics and Child Health

The home environment provides the context for much of a child's early development. Examples of important aspects of the home environment include safety, cleanliness, and opportunities for cognitive stimulation. This study sought to examine the psychometric properties of an adapted form of the Home Observation for the Measurement of the Environment (HOME; Caldwell & Bradley, 1984, 2003) across the eight international sites of the MAL-ED project (Dhaka, Bangladesh; Vellore, India; Bhakatapur, Nepal; Naushahro Feroze, Pakistan; Fortaleza, Brazil; Loreto, Peru; Venda, South Africa; Haydom, Tanzania), to identify a factor structure that fit the data at all sites, and to derive a …

Transfusion-Related Acute Lung Injury In A Paediatric Intensive Care Unit Of Pakistan, Muhammed Tariq, Zehra Dhanani, Qalab Abbas, Humaira Jurair, Farheen Karim Mahar, Anwarul Haque

Department of Paediatrics and Child Health

Background: Transfusion-Related Acute Lung Injury (TRALI) is a major cause of transfusionrelated morbidity and mortality in the intensive care unit setting. There is a paucity of such data from Pakistan. The purpose of this study is to assess the incidence and outcome of TRALI in critically ill children admitted in a pediatric intensive care unit (PICU) of Pakistan.
Methods: This is a retrospective cohort study of all critically ill or injured children who developed TRALI or "possible" TRALI after blood transfusion based on Canadian Conference Consensus criteria in a closed multidisciplinary-cardiothoracic PICU from January 2012 to June 2016. The demographic, …

Global Respiratory Syncytial Virus-Associated Mortality In Young Children (Rsv Gold): A Retrospective Case Series, Nienke M. Scheltema, Angela Gentile, Florencia Lucion, D James Nokes, Patrick K. Munywoki, Shabir A. Madhi, Michelle J. Groome, Cheryl Cohen, Jocelyn Moyes, Syed Asad Ali

Department of Paediatrics and Child Health

Background: Respiratory syncytial virus (RSV) infection is an important cause of pneumonia mortality in young children. However, clinical data for fatal RSV infection are scarce. We aimed to identify clinical and socioeconomic characteristics of children aged younger than 5 years with RSV-related mortality using individual patient data.

Methods: In this retrospective case series, we developed an online questionnaire to obtain individual patient data for clinical and socioeconomic characteristics of children aged younger than 5 years who died with community-acquired RSV infection between Jan 1, 1995, and Oct 31, 2015, through leading research groups for child pneumonia identified through a comprehensive …

Teaching Basic Pediatric Intensive Care Course To Pediatric Residents And Consultants, Humaira Jurair, Qalab Abbas, Anwar Ul Haque

Department of Paediatrics and Child Health

No abstract provided.

Frequency And Outcome Of Acute Neurologic Complications After Congenital Heart Disease Surgery, Sidra Kaleem Jafri, Lubaina Ehsan, Qalab Abbas, Fatima Ali, Prem Chand, Anwarul Haque

Department of Paediatrics and Child Health

Objectives: To determine the frequency and immediate outcome of acute neurologic complications (ANCs) in children undergoing congenital heart surgery (CHS).
Materials and Methods: Inthis retrospective study, all patients undergoing CHS at our hospital from January 2007 to June 2016 were included. Patients were followed up for the development of seizures, altered level of consciousness (ALOC), abnormal movements, and stroke. Results are presented as mean with standard deviation and frequency with percentages.
Results: Of 2000 patients who underwent CHS at our center during the study, 35 patients (1.75%) developed ANC. Seizures occurred in 28 (80%), ALOC in 5 (14%), clinical stroke …

Simplification Of The Finnegan Neonatal Abstinence Scoring System: Retrospective Study Of Two Institutions In The Usa, Enrique Gomez Pomar, Loretta P. Finnegan, Lori Delvin, Henrietta S. Bada, Vanessa A. Concina, Katrina T. Ibonia, Philip M. Westgate

Pediatrics Faculty Publications

Objective To develop a simplified Finnegan Neonatal Abstinence Scoring System (sFNAS) that will highly correlate with scores ≥ 8 and ≥12 in infants being assessed with the FNAS.

Design, setting and participants This is a retrospective analysis involving 367 patients admitted to two level IV neonatal intensive care units with a total of 40 294 observations. Inclusion criteria included neonates with gestational age ≥ 37 0/7 weeks, who are being assessed for neonatal abstinence syndrome (NAS) using the FNAS. Infants with a gestational age < 37 weeks were excluded.

Methods A linear regression model based on the original FNAS data from one institution was developed …

Randomised Controlled Trial Of Lactobacillus Rhamnosus (Lgg) Versus Placebo In Children Presenting To The Emergency Department With Acute Gastroenteritis: The Pecarn Probiotic Study Protocol., David Schnadower, Phillip I Tarr, Casper T Charles, Marc H Gorelick, Michael J Dean, Karen J O'Connell, Prashant Mahajan, Thomas H Chun, Seema R Bhatt, Cindy G Roskind, Elizabeth C Powell, Alexander J Rogers, Cheryl Vance, Robert E Sapien, Feng Gao, Stephen B Freedman

Pediatrics Faculty Publications

INTRODUCTION: Acute gastroenteritis (AGE) is a common and burdensome condition that affects millions of children worldwide each year. Currently available strategies are limited to symptomatic management, treatment and prevention of dehydration and infection control; no disease-modifying interventions exist. Probiotics, defined as live microorganisms beneficial to the host, have shown promise in improving AGE outcomes, but existing studies have sufficient limitations such that the use of probiotics cannot currently be recommended with confidence. Here we present the methods of a large, rigorous, randomised, double-blind placebo-controlled study to assess the effectiveness and side effect profile of Lactobacillus rhamnosus GG (LGG) (ATCC 53103) …