Ignite Creation Date:
2025-12-26 @ 3:58 PM
Ignite Modification Date:
2025-12-31 @ 12:13 PM
Study NCT ID:
NCT06620406
Status:
COMPLETED
Last Update Posted:
2025-08-26
First Post:
2024-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Synbiotic Therapy for NP-PASC
Sponsor:
Columbia University
Organization:
Study Overview
Official Title:
Pilot Study of Synbiotic Therapy for Neuropsychiatric PASC
Status:
COMPLETED
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
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 (n=15) or placebo (n=15). Both intervention and placebo will be similar in terms of appearance and taste, and participants will be asked to take the intervention or placebo with water twice daily, for up to 4 weeks. At the enrollment and study follow-up visit, the investigators 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 screening/enrollment visit.
There will be a total of two visits: screening/enrollment/randomization 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 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. The participant will then initiate the intervention or placebo, and the study staff will counsel and support the participants on administration of the intervention or placebo. 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 screening/enrollment visit.
There will be a total of two visits: screening/enrollment/randomization 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 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. The participant will then initiate the intervention or placebo, and the study staff will counsel and support the participants on administration of the intervention or placebo. 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:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: