Bacteriotherapy in the Treatment of COVID-19
キーワード
概要
説明
Italy was the first European country hit by the severe outbreak of the SARS-CoV-2 epidemic emerged from China, with a high morbidity and associated mortality.
Given the limited treatment options currently available, the search for resources capable of improving disease outcomes is fundamental for the management of patients
Systemic inflammation related to COVID-19, dietary changes, and use of antibiotics are all variables that contribute to changes in the gut microbiota with significant impact on the disease outcomes. Probiotic supplementation can help to correct these issues.
Moreover some strains of lactobacilli and bifidobacteria inhibit influenza virus, rhinovirus, respiratory syncytial virus, adenovirus, and pneumovirus .
日付
| 最終確認済み: | 03/31/2020 |
| 最初に提出された: | 04/26/2020 |
| 提出された推定登録数: | 04/26/2020 |
| 最初の投稿: | 04/28/2020 |
| 最終更新が送信されました: | 04/28/2020 |
| 最終更新日: | 05/03/2020 |
| 実際の研究開始日: | 02/29/2020 |
| 一次完了予定日: | 06/29/2020 |
| 研究完了予定日: | 07/30/2020 |
状態または病気
介入/治療
Dietary Supplement: bacteriotherapy
Drug: Azithromycin
Drug: hydroxychloroquine
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Standard of care Azithromycin 500mg 1 cp / day (alternatively lopinavir/ritonavir cps 200/50 mg, 2 cps x 2 / day or darunavir 800 mg 1 cp / day + ritonavir 100 mg 1 cp / day or darunavir/cobicistat 800/150 mg 1 cp / day), plus hydroxychloroquine cp 200 mg, 1 cp x 2 / day. | |
| bacteriotherapy Dietary Supplement: SivoMixx (200 billion) plus Azithromycin 500mg 1 cp / day (alternatively lopinavir/ritonavir cps 200/50 mg, 2 cps x 2 / day or darunavir 800 mg 1 cp / day + ritonavir 100 mg 1 cp / day or darunavir/cobicistat 800/150 mg 1 cp / day), and hydroxychloroquine cp 200 mg, 1 cp x 2 / day. | Dietary Supplement: bacteriotherapy Composition of SivoMixx: Streptococcus thermophilus DSM322245, Bifidobacterium lactis DSM 32246, Bifidobacterium lactis DSM 32247, Lactobacillus acidophilus DSM 32241, Lactobacillus helveticus DSM 32242, Lactobacillus paracasei DSM 32243, Lactobacillus plantarum DSM 32244, Lactobacillus brevis DSM 27961 (NB: DSM n°... : bacterial strain identification code) |
適格基準
| 研究の対象となる年齢 | 18 Years に 18 Years |
| 研究に適格な性別 | All |
| サンプリング方法 | Probability Sample |
| 健康なボランティアを受け入れる | はい |
| 基準 | Inclusion Criteria: - COVID-19 diagnosis - symptomatic COVID-19 - hospitalization in infectious diseases wards Exclusion Criteria: - Pregnant - hospitalization in Intensive Care Unit |
結果
主な結果の測定
1. delta of time of disappearance of acute diarrhea [21 days]
二次的な結果の測定
1. Delta in the number of patients requiring orotracheal intubation despite treatment [21 days]
2. Delta of crude mortality [21 days]
3. Delta of length of stay for patients in hospital [21 days]
