To evaluate the effect of fermented milk-based probiotic preparations on Helicobacter pylori eradication.
Systematic review of randomized controlled trials.
Electronic databases and hand search of ...reviews, bibliographies of books and abstracts and proceedings of international conferences.
Included trials had to be randomized or quasi-randomized and controlled, using fermented milk-based probiotics in the intervention group, treating Helicobacter-infected patients and evaluating improvement or eradication of H. pylori as an outcome.
The search identified 10 eligible randomized controlled trials. Data were available for 963 patients, of whom 498 were in the treatment group and 465 in the control group. The pooled odds ratio (studies n=9) for eradication by intention-to-treat analysis in the treatment versus control group was 1.91 (1.38-2.67; P<0.0001) using the fixed effects model; test for heterogeneity (Cochran's Q=5.44; P=0.488). The pooled risk difference was 0.10 (95% CI 0.05-0.15; P<0.0001) by the fixed effects model (Cochran's Q=13.41; P=0.144). The pooled odds ratio for the number of patients with any adverse effect was 0.51 (95% CI 0.10-2.57; P=0.41; random effects model; heterogeneity by Cochran's Q=68.5; P<0.0001).
Fermented milk-based probiotic preparations improve H. pylori eradication rates by approximately 5-15%, whereas the effect on adverse effects is heterogeneous.
Abstract
Introduction
Diabetes self-management education (DSME) helps patients self-manage their condition and improve outcomes/quality of life. However, access to DSME is limited, particularly in ...low-income areas. This study aims to develop a DSME training kit (EK-DIN), understand barriers to implementation, and evaluate the effectiveness and sustainability of community leader (CL)-based rollout using a stepped wedge cluster randomized trial format.
Methods and analysis
The mixed methods study will begin with a qualitative study to evaluate the facilitators and barriers towards CL-based DSME. The in-depth interview notes will be transcribed for thematic analysis. These results will be utilized for a stakeholder’s workshop to develop the EK-DIN kit, a patient-interfacing app, and an implementation plan. Rollout will be conducted in 30 clusters in Delhi, preselected by the DEDICOM-II survey in 5 steps (6 clusters every 3 months: 2 each from each socio-economic category; randomly selected per sequence). A CL from each cluster will be trained in using the EK-DIN kit/app over 1 month. The trained CL will conduct DSME sessions among the cluster residents using the EK-DIN kits provided fortnightly for 3 months. Compliance and blood parameters data will be collected at baseline, 3 months after the intervention, and every quarter thereafter till completion. Change in HbA1c before and after the intervention will be evaluated as the primary outcome using the swCRTdesign package for R version 4.0.2 and the swSummary function. The sustainability of the effects will be evaluated using the change in quarterly parameters after intervention completion.
Discussion
A positive result will set the template for a generalizable public health intervention with proven community effectiveness, sustainability, cost-effectiveness, and positive quality-of-life impact. While a negative result will require the testing of alternative approaches, it would still add substantially to existing knowledge on the subject. Given the diverse socio-cultural setting in which the trial is being proposed and the high power of the study, the results (positive or negative) should be widely applicable and have policy implications.
Trial registration
CTRI/2023/07/054963. Date of Registration: 7th July 2023.
Helicobacter pylori(H.pylori)eradication is considered a necessary step in the management of peptic ulcer disease,chronic gastritis,gastric adenocarcinoma and mucosa associated lymphoid tissue ...lymphoma.Standard triple therapy eradication regimens are inconvenient and achieve unpredictable and often poor results.Eradication rates are decreasing over time with increase in antibiotic resistance.Fermented milk and several of its component whey proteins have emerged as candidates for complementary therapy.In this context the current review seeks to summarize the current evidence available on their role in H.pylori eradication.Pertinent narrative/systematic reviews,clinical trials and laboratory studies on individual components including fermented milk,yogurt,whey proteins,lactoferrin,α-lactalbumin(α-LA),glycomacropeptide and immunoglobulin were comprehensively searched and retrieved from Medline,Embase,Scopus,Cochrane Controlled Trials Register and abstracts/proceedings of conferences up to May 2013.A preponderance of the evidence available on fermented milk-based probiotic preparations and bovine lactoferrin suggests a beneficial effect in Helicobacter eradication.Evidence forα-LA and immunoglobulins is promising while that for glycomacropeptide is preliminary and requires substantiation.The magnitude of the potential benefit documented so far is small and the precise clinical settings are ill defined.This restricts the potential use of this group as a complementary therapy in a nutraceutical setting hinging on better patient acceptability/compliance.Further work is necessary to identify the optimal substrate,fermentation process,dose and the ideal clinical setting(prevention/treatment,first line therapy/recurrence,symptomatic/asymptomatic,gastritis/ulcer diseases etc.).The potential of this group in high antibiotic resistance or treatment failure settings presents interesting possibilities and deserves further exploration.
Anticipating dire consequences, in 2020 the world braced itself for the unparalleled pandemic by resorting to unprecedented measures including stringent lockdowns, unforeseen social isolations, ...spotlight focus, resource diversions besides reorganized healthcare systems to name the quintessential few. Such unifocal convergence enhanced the vulnerabilities of patients dependent on non-COVID healthcare assistance. For a nation with a meagre allocation of 0.7 hospital beds per 1000 people and a lopsided doctor-population ratio of 1:1800, COVID-centric measures created unintended complications. Ironically, many succumbed in myriad ways, not due to the pandemic but due to the attributes of the survival measures. While such consequences cannot be reversed, we need to be able to draw learnings from all such experiences. Particularly, as healthcare advances into the 21st century and we evolve towards an individualized care model, the contrasting “blanket treatment approach,” while an understandable contingency measure for pandemic emergencies, warrants serious attention. With this narrative, we would like to highlight the anguish and frustration faced by the parents and the doctors as multifarious elements complexly entangled to delay a crucial surgery in a two-year-old child with prolonged RT-PCR positivity. Knowing that mankind is likely to face such pandemics again, future responses require us to visualize the whole picture from a zoomed-out perspective to be able to roll out a synchronized holistic strategy. One needs to introspect on the mutilations incurred, to help redesign our disaster management responses, in order to address “all cause” damage and not just the pandemic ones. Experience Framework This article is associated with the Patient, Family & Community Engagement lens of The Beryl Institute Experience Framework ( https://www.theberylinstitute.org/ExperienceFramework ). Access other PXJ articles related to this lens. Access other resources related to this lens.
BackgroundIn 2015, senior consultants at Sitaram Bhartia Institute of Science and Research saw several sick children in their outpatient clinics for which they had been seen in the emergency ...department the previous day. These children seemed to require admission but were sent home. This prompted us to review the paediatric care provided in our emergency department.MethodsA multidisciplinary team was formed to run this improvement initiative. Review of literature suggested that establishing a triage system around a prevalidated triage tool would help us deliver more appropriate care. The South African Triage Scale was selected and adapted.InterventionsWith the aim of delivering appropriate care to at least 50% of children, a series of sequential interventions were tested using the improvement methodology of Plan-Do-Study-Act (PDSA) cycles, an approach recommended by the Institute for Healthcare Improvement. Learnings from the PDSA cycle of the previous intervention helped decide the subsequent change idea. The interventions included training in use of tool, increasing nurse staffing levels, using team huddles as feedback opportunities, introducing nurse reminders, reducing non-productive work, developing local leadership and training a restricted group of locum paediatricians. Qualitative and quantitative information was analysed to retain or reject change ideas.ResultsAt baseline only 16%–17% of children were receiving appropriate care. The sequential changes resulted in a gradual improvement to a median of 63% of children receiving appropriate care by the end of 20 months.ConclusionsWe succeeded in establishing a paediatric emergency triage system and culture in the given setting through a unique enriching experience. We worked on removing systemic barriers and facilitating change while facing several unexpected outcomes. A sustained iterative approach may be the best way to achieving significant improvement in difficult settings like ours.
In the context of inadequate public spending on health care in India (0.9% of the GDP); government liberalized its policies in the form of subsidized lands and tax incentives, resulting in the ...mushrooming of private hospitals and clinics in India. Paradoxically, a robust framework was not developed for the regulation of these health care providers, resulting in disorganized health sector, inadequate financing models, and lack of prioritization of services, as well as a sub-optimal achievement of the Millennium Development Goals (MDG). We systematically reviewed the evidence base regarding regulation of private hospitals, applicability of private-public mix, state of health insurance and effective policy development for India, while seeking lessons on regulation of private health systems, from South African (a developing country) and Australian (a developed country) health care systems.
Post-partum quality of life is an inadequately studied and poorly understood outcome of delivery care, especially in low- and middle-income countries. Hence, we evaluated the postpartum quality of ...life and its clinic-demographic context as part of a 3-stage cluster randomized community survey (DECLARE; covered quality of care as primary outcome) conducted in 2009-2011 in Delhi. In stage 1 of participant selection(sampling), 20 wards (of 150; geographically defined administrative units) were selected using a probability-proportionate-to-size systematic method. In stage 2, one from each income stratum (high, middle, and low; multiple colonies within each ward) was selected from each ward by simple random sampling (total 60 colonies of 2311). In stage 3, a house-to-house survey was conducted to recruit ~1800 recently delivered women for the multidimensional work, which included quality-of-care, cost-of-care, and PPQOL. Among the participants, those with high school or above education were invited to administer the Mother-Generated Index and calculate the primary and secondary index scores (PIS and SIS). A total of 794 (of 857 eligible; 118846 households) women were administered MGI. The mean PIS was 4.695 percent CI 4.4-4.7 while the average SIS was 4.095 percent CI 3.8-4.2. The PIS was worse for primiparous vs. multiparous mothers. On multivariate analysis, poorer psychological state, obstetric complications, and premature delivery correlated with poorer QOL scores, while better gestational weight gain, higher age, and labor-pain relief correlated with better QOL scores. The study benchmarks the poor status of post-partum quality-of-life and documents the spectrum, severity, and complexity of its key social, psychological, physical, and demographic determinants.
IntroductionVitamin B12 deficiency is widely prevalent across many low- and middle-income countries, especially where the diet is low in animal sources. While many observational studies show ...associations between B12 deficiency in pregnancy and infant cognitive function (including memory, language and motor skills), evidence from clinical trials is sparse and inconclusive.Methods and analysisThis double-blind, multicentre, randomised controlled trial will enrol 720 vegetarian pregnant women in their first trimester from antenatal clinics at two hospitals (one in India and one in Nepal). Eligible mothers who give written consent will be randomised to receive either 250 mcg methylcobalamin or 50 mcg (quasi control), from enrolment to 6 months post-partum, given as an oral daily capsule. All mothers and their infants will continue to receive standard clinical care. The primary trial outcome is the offspring’s neurodevelopment status at 9 months of age, assessed using the Development Assessment Scale of Indian Infants. Secondary outcomes include the infant’s biochemical B12 status at age 9 months and maternal biochemical B12 status in the first and third trimesters. Maternal biochemical B12 status will also be assessed in the first trimester. Modification of association by a priori identified factors will also be explored.Ethical considerations and disseminationThe study protocol has been approved by ethical committees at each study site (India and Nepal) and at University College London, UK. The study results will be disseminated to healthcare professionals and academics globally via conferences, presentations and publications. Researchers at each study site will share results with participants during their follow-up visits.Trial registration numberCTRI/2018/07/015048 (Clinical Trial Registry of India); NCT04083560 (ClinicalTrials.gov)
Background: Vitamin B 12 deficiency is widely prevalent in all age groups which is of major concern. However, there is no valid Food Frequency Questionnaire (FFQ) for dietary vitamin B 12 estimation. ...Hence, we aimed to develop and validate an FFQ for the estimation of dietary intake of Vitamin B 12 . Materials and Methods: Commonly consumed B 12 -rich food items were selected from literature and filtered using a market survey. For concordant and discriminant validation, B 12 and homocysteine levels were estimated. To establish convergent validity, the Cobalamin Intake in North Indians by Food Frequency Questionnaire (COIN-FFQ) and 72-hour dietary recall (72HrDR) were both administered to the same subjects. The COIN-FFQ was readministered after initial administration for test–retest reliability. Internal consistency of the FFQ was then tested using Cronbach’s alpha. Results: We enrolled 115 adults with a mean age and weight of 31.9 ± 8.7 years and 66.0 ± 11.8 kg, respectively. In total, 19.1% were vegetarian. The dietary B 12 using COIN-FFQ ( n = 60; mean = 4.3 ± 1.8 µg/d) was significantly correlated ( r = 0.255; P = 0.049) with serum levels (mean = 120.1 ± 62.6 pmol/L) establishing concordant validity. A significant difference was noted between the dietary, serum B 12 , and homocysteine levels of vegetarians versus nonvegetarians establishing discriminant validity (mean diff 1.4 (0.5–2.4), P = 0.004; Z-statistic −2.182, P value 0.029, and Z-statistic −2.438; P value 0.015), respectively. FFQ was strongly correlated with 72HrDR and test–retest FFQ ( n = 27; r = 0.814, P < 0.001 and r = 0.869, P < 0.001, respectively) establishing convergent validity and test–retest reliability. The internal consistency with Cronbach’s alpha was in the acceptable range, 0.631 ( n = 115). Conclusion: The newly developed COIN-FFQ is valid and reliable in estimating dietary B 12 intake.
Given the postulated advantages of mother generated index (MGI) in incorporating the patients' viewpoint and in the absence of a validated India specific postpartum quality of life assessment tool we ...proposed to evaluate the utility of an adapted Mother-Generated-Index in assessing postpartum quality of life (PQOL) in India.
The study was integrated into a community survey conducted in one district of Delhi by two-stage cluster randomized sampling to recruit women who delivered in the last 6 months. PQOL was assessed using MGI. Physical morbidity and Edinburgh- postnatal-depression-scale (EPDS) were also recorded for validation purposes.
All subjects (249 of 282 eligible) participating in the survey were approached for the MGI evaluation which could be administered to 195 subjects due to inadequate comprehension or refusal of consent. A trend towards lower scores in lower socioeconomic stratum was observed (Primary index score-2.9, 3.7 and 4.0 in lower, middle and higher strata; Secondary Index Score-2.6, 3.2 and 3.0 in lower, middle and higher strata). 59.4% mothers had scores suggestive of possible depression (EPDS; n = 172). Primary index score had a good correlation with validator scores like EPDS (p = 0.024) and number of physical problems (p = 0.022) while the secondary index score was only associated with EPDS score (p = 0.020).
The study documents that the MGI, with its inherent advantages, is a potentially useful tool for postpartum quality of life evaluation in India especially in the absence of an alternative pre-validated tool.
PDF
