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- ||| KB109 / Kaleido Biosci
Trial completion: An Observational Clinical Study to Evaluate COVID-19 Symptoms in "Long Hauler" Patients Who Participated in K031-120 or K032-120 (clinicaltrials.gov) - Aug 18, 2021
P=N/A, N=333, Completed, Sponsor: Kaleido Biosciences
Recruiting --> Completed
- ||| KB109 / Kaleido Biosci
Trial completion: A Clinical Study to Assess the Physiologic Effects of KB109 in Patients With COVID-19 on Gut Microbiota Structure and Function (clinicaltrials.gov) - Aug 13, 2021
P=N/A, N=49, Completed, Sponsor: Kaleido Biosciences
Recruiting --> Completed Recruiting --> Completed
- ||| KB109 / Kaleido Biosci
Trial completion: A Clinical Study to Assess the Natural History of COVID-19 and Effects of KB109 and Supportive Self-care in Outpatients With Mild-to-moderate COVID-19 (clinicaltrials.gov) - Aug 13, 2021
P=N/A, N=350, Completed, Sponsor: Kaleido Biosciences
Recruiting --> Completed Active, not recruiting --> Completed
- KB109 / Kaleido Biosci
[VIRTUAL] Targeting the Microbiome with KB109 in Mild to Moderate COVID-19 Reduced Healthcare Utilization and Symptom Duration (Poster Hall) - May 31, 2021 - Abstract #WMF2021WMF_4900;
These results suggest that administration of KB109 may be associated with reduced times to resolution of COVID-19 symptoms and decreased rates of medically attended visits in non-hospitalized patients with mild to moderate COVID-19, especially in older patients and those with ≥1 comorbidity. Future evaluation of KB109 in larger studies is warranted to build upon these results and evaluate whether KB109 can reduce the development of long-term COVID-19 symptoms and symptom duration of other infections.
- KB109 / Kaleido Biosci
[VIRTUAL] Impact of one or more comorbidities and the microbiome metabolic therapy (MMT) KB109 on symptom resolution in non-hospitalised patients with mild to moderate COVID-19 () - May 20, 2021 - Abstract #ECCMID2021ECCMID_1417;
- KB109 / Kaleido Biosci
[VIRTUAL] Patient-reported comorbidity affects symptom duration in non-hospitalized patients with mild to moderate COVID-19 in a clinical study () - May 19, 2021 - Abstract #IMMUNOLOGY2021IMMUNOLOGY_2215;
We assessed outpatient natural history of COVID-19 as part of a clinical food study evaluating KB109 safety and its effects on select health measures when combined with supportive self-care (SSC) vs SSC alone... This is the first clinical study to show ≥1 comorbidity is associated with a protracted time to resolution of symptoms in non-hospitalized patients with mild to moderate COVID-19.
- || KB109 / Kaleido
Clinical, Clinical protocol, Journal: Virtualized clinical studies to assess the natural history and impact of gut microbiome modulation in non-hospitalized patients with mild to moderate COVID-19 a randomized, open-label, prospective study with a parallel group study evaluating the physiologic effects of KB109 on gut microbiota structure and function: a structured summary of a study protocol for a randomized controlled study. (Pubmed Central) - Apr 14, 2021
P=N/A
In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocols. The study protocols have been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional files 3 and 4).
- |||||| KB109 / Kaleido Biosci
New trial: An Observational Clinical Study to Evaluate COVID-19 Symptoms in "Long Hauler" Patients Who Participated in K031-120 or K032-120 (clinicaltrials.gov) - Mar 24, 2021
P, N=300, Recruiting, Sponsor: Kaleido Biosciences
- || KB109 / Kaleido Biosci
Trial initiation date: A Clinical Study to Assess the Physiologic Effects of KB109 in Patients With COVID-19 on Gut Microbiota Structure and Function (clinicaltrials.gov) - Feb 23, 2021
P=N/A, N=50, Recruiting, Sponsor: Kaleido Biosciences
The study protocols have been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional files 3 and 4). Initiation date: Jul 2020 --> Jan 2021
- KB109 / Kaleido Biosci
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: VITORA: Clinical Study to Evaluate the Effect of KB109 on the Gut Microbiome in Subjects Whose Gastrointestinal Tracts Are Colonized With Multiple Drug-resistant Organisms (clinicaltrials.gov) - Jan 22, 2021
P=N/A, N=3, Terminated, Sponsor: Kaleido Biosciences
Initiation date: Jul 2020 --> Jan 2021 N=50 --> 3 | Trial completion date: Nov 2020 --> Jun 2020 | Recruiting --> Terminated | Trial primary completion date: Nov 2020 --> Jun 2020; COVID-19 pandemic
- || KB109 / Kaleido Biosci
Enrollment closed, Trial primary completion date: A Clinical Study to Assess the Natural History of COVID-19 and Effects of KB109 and Supportive Self-care in Outpatients With Mild-to-moderate COVID-19 (clinicaltrials.gov) - Jan 22, 2021
P=N/A, N=350, Active, not recruiting, Sponsor: Kaleido Biosciences
N=50 --> 3 | Trial completion date: Nov 2020 --> Jun 2020 | Recruiting --> Terminated | Trial primary completion date: Nov 2020 --> Jun 2020; COVID-19 pandemic Recruiting --> Active, not recruiting | Trial primary completion date: Oct 2020 --> Feb 2021
- KB109 / Kaleido
[VIRTUAL] Development of a Novel Synthetic Glycan to Prevent Bacterial Infections and Ameliorate Respiratory Viral Infections () - Aug 14, 2020 - Abstract #IDWeek2020IDWEEK_1189;
KB109 represents an appealing activity profile and offers an opportunity to prevent enteric and systemic bacterial infections by promoting gut homeostasis and colonization resistance, and ameliorating respiratory viral infections by stimulating immune homeostasis. KB109 is under evaluation in two COVID-19 clinical studies.
- ||| KB109 / Kaleido Biosci
New trial: A Clinical Study to Assess the Physiologic Effects of KB109 in Patients With COVID-19 on Gut Microbiota Structure and Function (clinicaltrials.gov) - Jul 24, 2020
P=N/A, N=50, Recruiting, Sponsor: Kaleido Biosciences
- ||| KB109 / Kaleido Biosci
New trial: A Clinical Study to Assess the Natural History of COVID-19 and Effects of KB109 and Supportive Self-care in Outpatients With Mild-to-moderate COVID-19 (clinicaltrials.gov) - Jun 4, 2020
P=N/A, N=400, Recruiting, Sponsor: Kaleido Biosciences
- || KB109 / Kaleido Biosci
Trial completion date, Trial primary completion date: VITORA: Clinical Study to Evaluate the Effect of KB109 on the Gut Microbiome in Subjects Whose Gastrointestinal Tracts Are Colonized With Multiple Drug-resistant Organisms (clinicaltrials.gov) - Mar 12, 2020
P=N/A, N=50, Recruiting, Sponsor: Kaleido Biosciences
KB109 is under evaluation in two COVID-19 clinical studies. Trial completion date: Feb 2020 --> Nov 2020 | Trial primary completion date: Feb 2020 --> Nov 2020
- ||| KB109 / Kaleido Biosci
Enrollment open: VITORA: Clinical Study to Evaluate the Effect of KB109 on the Gut Microbiome in Subjects Whose Gastrointestinal Tracts Are Colonized With Multiple Drug-resistant Organisms (clinicaltrials.gov) - Jun 27, 2019
P=N/A, N=64, Recruiting, Sponsor: Kaleido Biosciences
Trial completion date: Feb 2020 --> Nov 2020 | Trial primary completion date: Feb 2020 --> Nov 2020 Not yet recruiting --> Recruiting
- ||| KB109 / Kaleido Biosci
New trial: VITORA: Clinical Study to Evaluate the Effect of KB109 on the Gut Microbiome in Subjects Whose Gastrointestinal Tracts Are Colonized With Multiple Drug-resistant Organisms (clinicaltrials.gov) - May 9, 2019
P=N/A, N=64, Not yet recruiting, Sponsor: Kaleido Biosciences