ObjectiveMicrobiome and dietary manipulation therapies are being explored for treating ulcerative colitis (UC). We aimed to examine the efficacy of multidonor faecal microbiota transplantation (FMT) and anti-inflammatory diet in inducing remission followed by long-term maintenance with anti-inflammatory diet in patients with mild-moderate UC.DesignThis open-labelled randomised controlled trial (RCT) randomised patients with mild-moderate (Simple Clinical Colitis Activity Index (SCCAI) 3–9) endoscopically active UC (Ulcerative Colitis Endoscopic Index of Severity (UCEIS)>1) on stable baseline medications in 1:1 ratio to FMT and anti-inflammatory diet (FMT-AID) versus optimised standard medical therapy (SMT). The FMT-AID arm received seven weekly colonoscopic infusions of freshly prepared FMT from multiple rural donors(weeks 0–6) with anti-inflammatory diet. Baseline medications were optimised in the SMT arm. Clinical responders (decline in SCCAI>3) at 8 weeks in both arms were followed until 48 weeks on baseline medications (with anti-inflammatory diet in the FMT-AID arm). Primary outcome measures were clinical response and deep remission (clinical—SCCAI <2; and endoscopic—UCEIS <1) at 8 weeks, and deep remission and steroid-free clinical remission at 48 weeks.ResultsOf the 113 patients screened, 73 were randomised, and 66 were included in (35—FMT-AID; 31—SMT) modified intention-to-treat analysis (age—35.7±11.1 years; male—60.1%; disease duration—48 (IQR 24–84) months; pancolitis—34.8%; SCCAI—6 (IQR 5–7); UCEIS—4 (IQR 3–5)). Baseline characteristics were comparable. FMT-AID was superior to SMT in inducing clinical response (23/35 (65.7%) vs 11/31 (35.5%), p=0.01, OR 3.5 (95% CI 1.3 to 9.6)), remission (21/35 (60%) vs 10/31 (32.3%), p=0.02, OR 3.2 (95% CI 1.1 to 8.7)) and deep remission (12/33 (36.4%) vs 2/23 (8.7%), p=0.03, OR 6.0 (95% CI 1.2 to 30.2)) at 8 weeks. Anti-inflammatory diet was superior to SMT in maintaining deep remission until 48 weeks (6/24 (25%) vs 0/27, p=0.007).ConclusionMultidonor FMT with anti-inflammatory diet effectively induced deep remission in mild-moderate UC which was sustained with anti-inflammatory diet over 1 year.Trial registration numberISRCTN15475780.

With the emergence of second wave of COVID-19 infection globally, particularly in India in March–April 2021, protection by massive vaccination drive has become the need of the hour. Vaccines have been proved to reduce the risk of developing severe illness and are emerging as vital tools in the battle against COVID-19. As per the GLOBOCAN database, nearly 19.3 million new cancer cases have been reported in 2020 globally, which posed a significant challenge to health care providers to protect such large number of ‘vulnerable’ patients from COVID-19. Nevertheless, a considerable degree of doubt, hesitancy and misconceptions are noted regarding the administration of vaccines particularly during active immuno-suppressant treatment. This review article highlights the added vulnerability of cancer patients to the COVID-19 infection and has explored the immunological challenges associated with malignancy, anticancer treatment and COVID-19 vaccination. Supplementary Information The online version contains supplementary material available at 10.1007/s12032-021-01540-8.

BackgroundTreatment for coronavirus disease 2019 (COVID-19) pneumonia remains largely supportive till date and multiple clinical trials took place within the short span of time to evaluate the role of investigational therapies. The anti-inflammatory effect of low dose whole lung radiation in treating pneumonia has been documented earlier. This clinical trial analyzed the effect of low dose radiation therapy (LDRT) in a moderately affected COVID-19 pneumonia patient cohort and has evaluated its effect in stopping the conversion of moderate disease into severe disease.MethodsPatients with moderate COVID-19 pneumonia as characterized by the Ministry of Health and Family Welfare (MOHFW), Government of India, were randomized (1:1) to low dose whole lung radiation versus no radiation. All treatment of patients was concurrently being given as per institutional protocol. Patients were followed up with clinical and laboratory parameters monitored on Days 1, 3, 7, and 14. Computed tomography scan (CT scan) of thorax was performed on Days 1 and 7. Patients were evaluated for conversion of moderate into severe disease as per National Early Warning Score-2 (NEWS-2 score) as the primary end point. The secondary endpoints included changes in ratio between peripheral capillary oxygen saturation and fraction of inspired oxygen (SpO2/FiO2), biochemical markers, 25-point CT severity score, and radiation induced acute pulmonary toxicities.FindingsAt the interim analysis, there were seven patients in the radiation arm and six in the control. A whole lung LDRT improved the outcome of SpO2/FiO2 at Day 3; however it did not convert into a statistically significant improvement for the NEWS-2 score. The serum levels of LDH, CRP, Ferritin and D-dimer were significantly reduced on 14 days in the LDRT arm in comparison to the baseline value but were not significant between the two groups.InterpretationLDRT seems to have the potential to prevent moderate COVID-19 pneumonia from a deteriorating to severe category. However, further randomized clinical trial with an adequate number of such patients is warranted to establish the definitive role of LDRT in the management of COVID-19 pneumonia.FundingAn intramural research project bearing code: I-27/621, was sanctioned from the All India Institute of Medical Sciences, Patna, India.Clinical Trial RegistrationClinical Trials Registry-India (CTRI/2021/06/033912, 25th May 2021) ctri.nic.in/Clinicaltrials/login.php

BACKGROUND: Hypothermia at admission to neonatal intensive care units (NICU) is associated with increased morbidity and mortality in newborns. A baseline study at a tertiary care hospital with all out-born babies showed admission hypothermia of 82%. OBJECTIVE: To reduce admission hypothermia (moderate) in newborns at least by 50% in next 6 months. METHODS: A quality improvement (QI) study was planned using WHO Point of Care Quality Improvement Model (POCQI), [17] using PDSA (Plan-Do-Study-Act) cycle approach from April 2018 to March 2019, and including 427 term and preterm babies. We educated the staff, reinforced the use of caps, cling wraps, warm linen, introduced Ziploc bags and ensured adequate use of transport incubator. RESULTS: After 6 months, overall admission hypothermia decreased from 82% to 45%, moderate hypothermia reduced from 46% to <10% (P <  0.001) and severe hypothermia (3%) was completely eliminated. There was also significant reduction in incidence of IVH (13% Vs 4.7%), LONS (38% Vs 19%) and metabolic acidosis (43% Vs 28%). We were able to sustain this improvement for the next 6 months and is ongoing. The strongest predictor of hypothermia was newborns being in the phase before QI initiative was started (OR 2.36, 95% CI 1.47, 3.23). CONCLUSION: This study is a cost effective approach in reducing admission hypothermia in NICU in a resource limited setting with all outborn babies, and further decreasing the morbidity associated with it. Hence, emphasizing the importance of maintaining euthermia, not only in delivery rooms, but also during transportation.

Background Crohn’s disease (CD) and intestinal tuberculosis (ITB) are chronic granulomatous inflammatory disorders characterized by a compromised mucosal immunity. Even with diverging etiologies, CD and ITB presents an uncanny resemblance in clinical manifestation resulting in diagnostic dilemma. The gut microbiota regulates myriad of gut mucosal immunological processes. Present study aims to decipher gut microbial dysbiosis in the two disorders and utilize the CD and ITB-specific gut dysbiosis to construct a machine learning (ML)-based predictive model, which can aid in their differential diagnosis. Methods Fecal samples from healthy controls (n=12) and from patients with CD (n=23) and ITB (n=25) were subjected to 16S (V3-V4) amplicon sequencing. Processing of raw reads, construction of ASV feature tables, diversity, core microbiome analysis and ML classifier construction was done using QIIME2-2021.4. Differential abundance analysis (DAA) between the groups was carried out using Deseq2, after adjusting for the subject-specific confounders. Results The α and β diversity indices in CD and ITB groups were significantly reduced than HC group (p = 0.011 and 0.012 resp.), with no significant differences between the two diseases (Fig.1A, 1B). On comparison with HC, CD and ITB groups showed reduction in members of Firmicutes and Bacteroidetes, with enhancement of Actinobacteria and Proteobacteria (Fig.1C and 1D). DAA (FDR q &lt;0.1, FC &gt;2.5) between CD and ITB groups revealed expansion of Succinivibrio dextrinisolvens, Odoribacter splanchnicus, Megasphaera massiliensis, Bacteroides uniformis and B.xylanisolvens in CD group, while Clostridium sp., Haemophilus parainfluenzae and Bifidobacterium sp. were elevated in ITB (Fig.2A). Random Forest-based ML model constructed on the basis of raw microbiome reads and using 80% of the samples to train the model, showed predictive accuracy of 0.78 (AUC=93%). (Fig.2B) Conclusion Our study shows that CD and ITB witnesses significant changes in gut microbial structure. With no significant differences in microbial diversity between two diseases, the signature of gut dysbiosis is distinct between CD and ITB. Exploitation of these differences to construct ML models can potentiate differential diagnosis of CD and ITB.