Evaluation of a Synbiotic Formula in Patient With COVID-19

NCT04730284 | Unknown

• 1 other identifier: COVSyn
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

A series of microbiota were correlated inversely with the disease severity and virus load. Gut microbiota could play a role in modulating host immune response and potentially influence disease severity and outcomes.

Conditions

Coronavirus

Keywords

microbiota

Outcome Measures

Primary Outcomes (1)

• Changes in gut microbiome

  Changes in the gut microbiome (bacteria, virome and fungome) measured by metagenomics at week 5 compared to baseline

  week 5

Secondary Outcomes (7)

• Changes in fecal bacteria metabolites

  weeks 2, 4, 5, 8 and months 3, 6, 9 and 12

• Change in plasma cytokines including IL-6, IL-IB, TNF-a and CXCL-10

  week 5

• Trend in symptom score

  weeks 2, 4, 5, 8 and months 3, 6, 9 and 12

• Change in Quality of life measured by EQ-5D-5L

  weeks 2, 4, 5, 8 and months 3, 6, 9 and 12

• Change in Quality of life measured by SF-12

  weeks 2, 4, 5, 8 and months 3, 6, 9 and 12

Study Arms (1)

Health supplements

EXPERIMENTAL

One arm only

Other: Health supplements

Interventions

Health supplements OTHER

tailor-made Synbiotics, 4g per day for 28 days

Health supplements

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 or above; and
• A confirmed diagnosis of SARS-Cov.2 infection using the PCR according to the standard of according to Centre for Health Protection, Department of Health, HK and released from isolation at recruitment.
• Written informed consent obtained

You may not qualify if:

• Known allergy or intolerance to the intervention product or its components
• Any known medical condition that would prevent taking oral probiotics or increase risks associated with probiotics including but not limited to inability to swallow/aspiration risk and no other methods of delivery (e.g., no G/J tube)
• Known increased infection risk due to immunosuppression such as:
• Prior organ or hematopoietic stem cell transplant
• Neutropenia (ANC \<500 cells/ul)
• HIV and CD4 \<200 cells/ul
• Known increased infection risk due to endovascular due to:
• Rheumatic heart disease
• Congenital heart defect,
• Mechanical heart valves
• Endocarditis
• Endovascular grafts
• Permanent endovascular devices such as permanent (not short-term) hemodialysis catheters, pacemakers, or defibrillators
• Documented pregnancy

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Related Publications (12)

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  PMID: 31986264 BACKGROUND

• Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.

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• Holshue ML, DeBolt C, Lindquist S, Lofy KH, Wiesman J, Bruce H, Spitters C, Ericson K, Wilkerson S, Tural A, Diaz G, Cohn A, Fox L, Patel A, Gerber SI, Kim L, Tong S, Lu X, Lindstrom S, Pallansch MA, Weldon WC, Biggs HM, Uyeki TM, Pillai SK; Washington State 2019-nCoV Case Investigation Team. First Case of 2019 Novel Coronavirus in the United States. N Engl J Med. 2020 Mar 5;382(10):929-936. doi: 10.1056/NEJMoa2001191. Epub 2020 Jan 31.

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  PMID: 32102928 BACKGROUND

• Hashimoto T, Perlot T, Rehman A, Trichereau J, Ishiguro H, Paolino M, Sigl V, Hanada T, Hanada R, Lipinski S, Wild B, Camargo SM, Singer D, Richter A, Kuba K, Fukamizu A, Schreiber S, Clevers H, Verrey F, Rosenstiel P, Penninger JM. ACE2 links amino acid malnutrition to microbial ecology and intestinal inflammation. Nature. 2012 Jul 25;487(7408):477-81. doi: 10.1038/nature11228.

  PMID: 22837003 BACKGROUND

• Zuo T, Zhan H, Zhang F, Liu Q, Tso EYK, Lui GCY, Chen N, Li A, Lu W, Chan FKL, Chan PKS, Ng SC. Alterations in Fecal Fungal Microbiome of Patients With COVID-19 During Time of Hospitalization until Discharge. Gastroenterology. 2020 Oct;159(4):1302-1310.e5. doi: 10.1053/j.gastro.2020.06.048. Epub 2020 Jun 26.

  PMID: 32598884 BACKGROUND

• WHO Coronavirus Disease (COVID-19) Dashboard. [Assessed on 24 Jul 2020]. https://covid19.who.int/

  BACKGROUND

• Cao B, Wang Y, Wen D, Liu W, Wang J, Fan G, Ruan L, Song B, Cai Y, Wei M, Li X, Xia J, Chen N, Xiang J, Yu T, Bai T, Xie X, Zhang L, Li C, Yuan Y, Chen H, Li H, Huang H, Tu S, Gong F, Liu Y, Wei Y, Dong C, Zhou F, Gu X, Xu J, Liu Z, Zhang Y, Li H, Shang L, Wang K, Li K, Zhou X, Dong X, Qu Z, Lu S, Hu X, Ruan S, Luo S, Wu J, Peng L, Cheng F, Pan L, Zou J, Jia C, Wang J, Liu X, Wang S, Wu X, Ge Q, He J, Zhan H, Qiu F, Guo L, Huang C, Jaki T, Hayden FG, Horby PW, Zhang D, Wang C. A Trial of Lopinavir-Ritonavir in Adults Hospitalized with Severe Covid-19. N Engl J Med. 2020 May 7;382(19):1787-1799. doi: 10.1056/NEJMoa2001282. Epub 2020 Mar 18.

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• Docherty AB, Harrison EM, Green CA, Hardwick HE, Pius R, Norman L, Holden KA, Read JM, Dondelinger F, Carson G, Merson L, Lee J, Plotkin D, Sigfrid L, Halpin S, Jackson C, Gamble C, Horby PW, Nguyen-Van-Tam JS, Ho A, Russell CD, Dunning J, Openshaw PJ, Baillie JK, Semple MG; ISARIC4C investigators. Features of 20 133 UK patients in hospital with covid-19 using the ISARIC WHO Clinical Characterisation Protocol: prospective observational cohort study. BMJ. 2020 May 22;369:m1985. doi: 10.1136/bmj.m1985.

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• Janowitz T, Gablenz E, Pattinson D, Wang TC, Conigliaro J, Tracey K, Tuveson D. Famotidine use and quantitative symptom tracking for COVID-19 in non-hospitalised patients: a case series. Gut. 2020 Sep;69(9):1592-1597. doi: 10.1136/gutjnl-2020-321852. Epub 2020 Jun 4.

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MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Siew Ng, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristy Ho, Bsc

CONTACT

85235053855; hiutungho@cuhk.edu.hk

Kitty Cheung, MPH

CONTACT

85226373225; kittyccy@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: January 29, 2021
• Study Start: August 25, 2020
• Primary Completion: September 30, 2021
• Study Completion: March 31, 2022
• Last Updated: January 29, 2021

Record last verified: 2021-01

Locations

HK (1)