Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06620406
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
Synbiotic Therapy for NP-PASC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pilot Study of Synbiotic Therapy for Neuropsychiatric PASC
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Gut microbiome dysbiosis has been noted in patients with Post-acute sequelae PASC of Severe Acute Respiratory Syndrome-CoronaVirus -2 SARS-CoV-2 A study performed at Columbia found that plasma levels of the short chain fatty acid SCFA butyric acid remained lower in people with Neuropsychiatric PASC NP-PASC than in people with PASC after SAR-CoV-2 infection Synbiotics improve SCFA levels and are well-tolerated in the general population but have not been studied among people with PASC in the United States The purpose of this pilot study is to characterize changes in plasma SCFA levels and gut microbiome after treatment with synbiotics and placebo in people with NP-PASC The intervention will be a mixture of the prebiotic resistant starch and the probiotic Bifidobacterium adolescentis in-vivo selection 1 strain iVS-1 The placebo will be Maltodextrin
Detailed Description:
In this pilot study up to 30 participants with NP-PASC at Columbia University Medical Center CUIMC will be randomized to take the intervention n15 or placebo n15 Both intervention and placebo will be similar in terms of appearance and taste and participants will be asked to take them with water twice daily for up to 4 weeks At the enrollment and study follow-up visit we will obtain data on acceptability and feasibility including feasibility of assessing adherence and outcomes and collect blood rectal swabs and stool for outcome assessment
The study intervention is a mixture of the prebiotic potato RS Bobs Red Mill and the probiotic IVS-1 Bifidobacterium adolescentis One dose will be RS and IVS-1 mixed together in a single-use sachet The placebo will be Maltodextrin a carbohydrate packaged similarly to the intervention Participants will take one dose twice daily with water for 4 weeks Each participant will receive a 4-week supply of sachets at the screeningenrollment visit
There will be a total of two visits screeningenrollmentrandomization and week 4 During the screening visit study information will be provided to potential participants and interested participants will sign an informed consent and undergo screening procedures Those who meet eligibility criteria will then undergo their enrollment and randomization procedures on the same day Data on sociodemographic and medical history will be collected using surveys and relevant samples will also be collected at the first visit as well as a self-administered rectal swab and self-collected stool for gut microbiome studies and blood test for SCFA levels They will then initiate the intervention or placebo and the study staff will counsel and support the participants on their administration At the 4-week visit clinical data and samples will be collected as well as data on acceptability feasibility adherence
The study intervention is a mixture of the prebiotic potato RS Bobs Red Mill and the probiotic IVS-1 Bifidobacterium adolescentis One dose will be RS and IVS-1 mixed together in a single-use sachet The placebo will be Maltodextrin a carbohydrate packaged similarly to the intervention Participants will take one dose twice daily with water for 4 weeks Each participant will receive a 4-week supply of sachets at the screeningenrollment visit
There will be a total of two visits screeningenrollmentrandomization and week 4 During the screening visit study information will be provided to potential participants and interested participants will sign an informed consent and undergo screening procedures Those who meet eligibility criteria will then undergo their enrollment and randomization procedures on the same day Data on sociodemographic and medical history will be collected using surveys and relevant samples will also be collected at the first visit as well as a self-administered rectal swab and self-collected stool for gut microbiome studies and blood test for SCFA levels They will then initiate the intervention or placebo and the study staff will counsel and support the participants on their administration At the 4-week visit clinical data and samples will be collected as well as data on acceptability feasibility adherence
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None