Investigating the paradox of intra-individual double burden of anthropometric undernutrition andmetabolic overnutrition in Indian Children: a prevention paradigm - NIL

开始日期2023-11-15

申办/合作机构

Department of Biotechnology, Government of India

CTRI/2023/10/059081 / Not yet recruiting临床2期IIT

Impact of fortified rice and vitamin C rich food on iron status of anaemic school age children (6-12 years)

开始日期2023-11-01

申办/合作机构

Department of Biotechnology, Government of India

CTRI/2023/10/058315 / Not yet recruitingN/AIIT

Amyloid hydrogel as a scaffold for the development of patient centric-breast cancer organoids for high-throughput screening of anticancer therapeutics - Nil

开始日期2023-10-26

申办/合作机构

Department of Biotechnology, Government of India

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项与 Department of Biotechnology, Government of India 相关的文献（医药）

2014-06-01·The Lancet1区 · 医学

Efficacy of a monovalent human-bovine (116E) rotavirus vaccine in Indian infants: a randomised, double-blind, placebo-controlled trial

1区 · 医学

Article

作者: Thiry, Georges ; John, Jacob ; Muliyil, Jayaprakash ; Bhandari, Nita ; Harshavardhan, G V J A ; Shaikh, Hanif ; Bavdekar, Ashish ; Kohberger, Robert ; Greenberg, Harry B ; Glass, Roger ; Antony, Kalpana ; Goyal, Nidhi ; Curlin, George ; Boslego, John ; Rongsen-Chandola, Temsunaro ; Arya, Alok ; Mohan, Krishna ; Kawade, Anand ; Abraham, Vinod ; Vrati, Sudhanshu ; Rathore, Sudeep Singh ; Taneja, Sunita ; Kang, Gagandeep ; Juvekar, Sanjay ; Bhan, Maharaj Kishan ; Rao, T S ; Proschan, Michael ; Prasad, Sai

BACKGROUNDRotavirus is the most common cause of severe dehydrating gastroenteritis in developing countries. Safe, effective, and affordable rotavirus vaccines are needed in these countries. We aimed to assess the efficacy and tolerability of a monovalent human-bovine rotavirus vaccine for severe rotavirus gastroenteritis in low-resource urban and rural settings in India.METHODSWe did a randomised double-blind, placebo-controlled, multicentre trial at three sites in Delhi (urban), Pune (rural), and Vellore (urban and rural) between March 11, 2011, and Nov 5, 2012. Infants aged 6-7 weeks were randomly assigned (2:1), via a central interactive voice or web response system with a block size of 12, to receive either three doses of oral human-bovine natural reassortant vaccine (116E) or placebo at ages 6-7 weeks, 10 weeks, and 14 weeks. Infants' families, study investigators, paediatricians in referral hospitals, laboratory staff, and committee members were all masked to treatment allocation. The primary outcome was incidence of severe rotavirus gastroenteritis (≥11 on the Vesikari scale). Efficacy outcomes and adverse events were ascertained through active surveillance. Analysis was by intention to treat and per protocol. The trial is registered with Clinical Trial Registry-India (CTRI/2010/091/000102) and ClinicalTrials.gov (NCT01305109).FINDINGS4532 infants were assigned to receive the 116E vaccine and 2267 to receive placebo, of whom 4354 (96%) and 2187 (96%) infants, respectively, were included in the primary per-protocol efficacy analysis. 71 events of severe rotavirus gastroenteritis were reported in 4752 person-years in infants in the vaccine group compared with 76 events in 2360 person-years in those in the placebo group; vaccine efficacy against severe rotavirus gastroenteritis was 53·6% (95% CI 35·0-66·9; p=0·0013) and 56·4% (36·6-70·1; p<0·0001) in the first year of life. The number of infants needed to be immunised to prevent one severe rotavirus gastroenteritis episode was 55 (95% CI 37-97). The incidence of severe rotavirus gastroenteritis per 100 person-years was 1·5 in the vaccine group and 3·2 in the placebo group, with an incidence rate ratio of 0·46 (95% CI 0·33-0·65). Prevalence of immediate, solicited, and serious adverse events was similar in both groups. One case of urticaria in the vaccine group and one each of acute gastroenteritis and suspected sepsis in the placebo group were regarded as related to the study product. We recorded six cases of intussusception in the vaccine group and two in the placebo group, all of which happened after the third dose. 25 (<1%) infants in the vaccine group and 17 (<1%) in the placebo group died; no death was regarded as related to the study product.INTERPRETATIONMonovalent human-bovine (116E) rotavirus vaccine is effective and well tolerated in Indian infants.FUNDINGDepartment of Biotechnology and the Biotechnology Industry Research Assistance Council, Government of India; Bill & Melinda Gates Foundation to PATH, USA; Research Council of Norway; UK Department for International Development; National Institutes of Health, Bethesda, USA; and Bharat Biotech International, Hyderabad, India.

Food & Function2区 · 医学

Gut microbiota in mental health and depression: role of pre/pro/synbiotics in their modulation

2区 · 医学

Review

作者: Bishnoi, Mahendra ; Sharma, Shyam Sunder ; Methiwala, Hasnain N. ; Addanki, Vamsi Krishna ; Vaidya, Bhupesh ; Kondepudi, Kanthi Kiran

A review of antidepressant mechanismsviagut microbe alterations with insight into how they can provide an alternative to antidepressant therapy without the side effects and risk of adverse drug reactions.

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