Effect of Lactobacillus on the Microbiome of Household Contacts Exposed to COVID-19

NCT04399252 | Completed

• 1 other identifier: Pro00105674
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effect of the probiotic Lactobacillus rhamnosus GG (LGG) and the effect of COVID-19 on the microbiome (the microorganisms that live in and on the human body) in exposed household contacts of COVID-19. This is a randomized, double-blind, placebo-controlled study, meaning subjects will be randomly assigned to receive LGG or a placebo (an inactive substance given in the same form as the active substance) and will not know which product they are receiving. Subjects will participate in the study for around 60 days. All subjects must refrain from taking any other probiotics while on study. All subjects must have access to e-mail and the internet to complete study questionnaires. Participation in this study entails taking LGG/placebo for 28 days, responding to questionnaires, and providing stool and nasal swab samples.

Conditions

Microbiome

Keywords

COVID-19; Lactobacillus rhmanosus GG

Outcome Measures

Primary Outcomes (1)

• Incidence of one or more symptoms of COVID-19 during the study period

  Incidence of one or more symptoms of COVID-19 (fever, chills, headache, muscle aches, runny nose, sore throat, cough, shortness of breath, nausea or vomiting, diarrhea, stomach upset or pain, excessive bloating or gas, constipation, loss of sense of smell, loss of sense of taste, rash, painful toes, or other symptoms related to COVID-19 diagnosis) during the study period

  60 days

Secondary Outcomes (4)

• Incidence of laboratory-confirmed COVID-19 during the study period

  60 days

• Complications of COVID-19

  60 days

• Types of symptoms of COVID-19

  60 days

• Duration of symptoms of COVID-19

  60 days

Other Outcomes (1)

• Change in Shannon Diversity in patients that develop COVID-19

  Baseline, Day 7, Day 28

Study Arms (2)

LGG Arm

EXPERIMENTAL

Participants in this arm will be given LGG for 28 days.

Dietary Supplement: Lactobacillus rhamnosus GG

Placebo

PLACEBO COMPARATOR

Participants in this arm will be given a placebo for 28 days.

Dietary Supplement: Lactobacillus rhamnosus GG Placebo

Interventions

Lactobacillus rhamnosus GG DIETARY_SUPPLEMENT

Participants will take 2 capsules per day of either LGG or placebo.

LGG Arm

Lactobacillus rhamnosus GG Placebo DIETARY_SUPPLEMENT

Participants will take 2 capsules per day of LGG placebo

Placebo

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>=1 year (as children \<1 year may not be able to take oral probiotics)
• Household contact of someone diagnosed with COVID-19
• Access to e-mail/internet to complete electronic consent via REDCap

You may not qualify if:

• Symptoms of COVID-19 at enrollment, including:
• Fever
• Respiratory symptoms
• GI symptoms
• Anosmia
• Ageusia -\>7 days since original patient associated with household contact was diagnosed with COVID-19
• Taking hydroxychloroquine or remdesivir for any reason (as this would have the potential to decrease the expected rate of COVID-19 in this population and affect our power and sample size calculations)
• Enrolled in a COVID-19 prophylaxis study (as this would have the potential to decrease the expected rate of COVID-19 in this population and affect our power and sample size calculations)
• Any 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)
• Increased infection risk due to immunosuppression due to:
• Chronic immunosuppressive medication
• Prior organ or hematopoietic stem cell transplant
• Known neutropenia (ANC \<500 cells/ul)
• HIV and CD4 \<200 cells/ul

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

Related Publications (2)

• Wischmeyer PE, Tang H, Ren Y, Bohannon L, Jiang D, Bergens M, Ramirez ZE, Andermann TM, Messina JA, Sung JA, Jensen D, Jung SH, Artica A, Britt A, Bush A, Johnson E, Lew MV, Winthrop H, Pamanes C, Racioppi A, Zhao AT, Wan Z, Surana NK, Sung AD. Efficacy of probiotic treatment as post-exposure prophylaxis for COVID-19: A double-blind, Placebo-Controlled Randomized trial. Clin Nutr. 2024 Jan;43(1):259-267. doi: 10.1016/j.clnu.2023.11.043. Epub 2023 Dec 11.

  PMID: 38103462 DERIVED

• Tang H, Bohannon L, Lew M, Jensen D, Jung SH, Zhao A, Sung AD, Wischmeyer PE. Randomised, double-blind, placebo-controlled trial of Probiotics To Eliminate COVID-19 Transmission in Exposed Household Contacts (PROTECT-EHC): a clinical trial protocol. BMJ Open. 2021 May 5;11(5):e047069. doi: 10.1136/bmjopen-2020-047069.

  PMID: 33952552 DERIVED

Related Links

• Pre-print: Daily Lactobacillus Probiotic versus Placebo in COVID-19-Exposed Household Contacts (PROTECT-EHC): A Randomized Clinical Trial

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Anthony Sung, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Paul Wischmeyer, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 22, 2020
• Study Start: June 24, 2020
• Primary Completion: July 8, 2021
• Study Completion: July 8, 2021
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)