Ignite Creation Date:
2025-12-18 @ 8:40 AM
Ignite Modification Date:
2025-12-18 @ 8:40 AM
Study NCT ID:
NCT03582085
Status:
None
Last Update Posted:
2024-11-21 00:00:00
First Post:
2018-06-18 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase II Clinical Trial: Multi-dosing the BCG Vaccine for Fibromyalgia
Sponsor:
None
Organization:
Study Overview
Official Title:
Phase II Clinical Trial: Multi-dosing the BCG Vaccine for Fibromyalgia
Status:
None
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No funding at the current time.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators are doing this research study to explore whether the bacillus Calmette-Guérin (BCG) vaccine can be an effective treatment for fibromyalgia. The researchers believe that the BCG vaccine can benefit people with fibromyalgia by increasing immune signaling molecules, called cytokines. The Faustman Immunobiology Laboratory has previously studied BCG in long term type 1 diabetics, and found that BCG vaccinations showed a short and small pancreas effect of restored insulin secretion.
Eligible volunteers will be vaccinated with BCG in repeat fashion over a period of three years or receive placebo treatment. The investigators hypothesize that these repeat injections of BCG will reduce symptom severity by increasing immune signaling cytokines.
Eligible volunteers will be vaccinated with BCG in repeat fashion over a period of three years or receive placebo treatment. The investigators hypothesize that these repeat injections of BCG will reduce symptom severity by increasing immune signaling cytokines.
Detailed Description:
None
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?: