Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-01-01 @ 8:28 PM
Study NCT ID:
NCT06771492
Status:
RECRUITING
Last Update Posted:
2025-08-06
First Post:
2024-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Antibiotic Treatment for Patients With Chronic Low Back Pain and Modic Type I Changes - Randomized Placebo-controlled Trial
Sponsor:
Bart Koes
Organization:
Study Overview
Official Title:
Efficacy of Antibiotic Treatment for Patients With Chronic Low Back Pain and Modic Type I Changes - Randomized Placebo-controlled Trial
Status:
RECRUITING
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:
ABBA
Brief Summary:
The goal of this clinical trial is to learn if antibiotics (amoxicillin) work to treat chronic low back pain in adults. In some patients, this type of back pain may be caused by bacteria in the vertebrae, resulting in a condition known as "Modic type I change."
The main questions the trial aims to answer are:
* What is the efficacy (primary objective) of antibiotic treatment for patients with chronic low back pain and Modic type I changes?
* What is the cost-effectiveness (secondary objective) of antibiotic treatment for patients with chronic low back pain and Modic type I changes?
Researchers will compare amoxicillin to a placebo (a look-alike substance that contains no active drug) to see if amoxicillin works to treat chronic low back pain.
Participants in the trial will:
* Be invited for an MRI scan to determine if they have a Modic type I change; those who do will be included in the study.
* Take either amoxicillin or a placebo daily for 100 days.
* Take probiotics daily for 100 days to reduce the occurrence and impact of any side effects from the antibiotics.
* Attend clinic visits at baseline (the start), 4 weeks, 3 months, and 12 months for checkups and tests.
* Complete questionnaires at baseline, 3 months, 6 months, and 12 months.
The main questions the trial aims to answer are:
* What is the efficacy (primary objective) of antibiotic treatment for patients with chronic low back pain and Modic type I changes?
* What is the cost-effectiveness (secondary objective) of antibiotic treatment for patients with chronic low back pain and Modic type I changes?
Researchers will compare amoxicillin to a placebo (a look-alike substance that contains no active drug) to see if amoxicillin works to treat chronic low back pain.
Participants in the trial will:
* Be invited for an MRI scan to determine if they have a Modic type I change; those who do will be included in the study.
* Take either amoxicillin or a placebo daily for 100 days.
* Take probiotics daily for 100 days to reduce the occurrence and impact of any side effects from the antibiotics.
* Attend clinic visits at baseline (the start), 4 weeks, 3 months, and 12 months for checkups and tests.
* Complete questionnaires at baseline, 3 months, 6 months, and 12 months.
Detailed Description:
None
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2024-515824-35-01 | CTIS | None | View |