Ignite Creation Date:
2024-05-05 @ 9:17 PM
Last Modification Date:
2024-10-26 @ 10:02 AM
Study NCT ID:
NCT00852124
Status:
TERMINATED
Last Update Posted:
2023-04-20
First Post:
2009-02-13
Brief Title:
Safety of VSL3 in Adult Asthmatics
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Safety of VSL3 for Adult Asthmatics
Status:
TERMINATED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Inadequate recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We are proposing to test the safety of the probiotic VSL3 in a placebo controlled double blind safety study in 30 asthmatic adults This adult safety trial was requested by the FDA IND review of a pediatric asthma protocol
Adults with a doctor diagnosis of persistent asthma will take VSL3 or placebo twice daily for 3 months Data will be collected including age race height and weight present medications past medical history with emphasis on signssymptoms of asthma
On visits to the clinic we will evaluate
Changes in lung function
Intestinal permeability
Intestinal bacteria
Levels of inflammation in the blood
Women will have repeat urine pregnancy testing at each clinic visit
Adults with a doctor diagnosis of persistent asthma will take VSL3 or placebo twice daily for 3 months Data will be collected including age race height and weight present medications past medical history with emphasis on signssymptoms of asthma
On visits to the clinic we will evaluate
Changes in lung function
Intestinal permeability
Intestinal bacteria
Levels of inflammation in the blood
Women will have repeat urine pregnancy testing at each clinic visit
Detailed Description:
The monitored parameters that will be assessed at each clinic visit or phone call include
1 the number of days with asthma related symptoms of cough wheeze dyspnea awakening at night and exercise limitation
2 the number of asthma-related missed schoolwork days
3 the amount of use of asthma rescue medications
4 use of non-inhaled steroids
5 change in medications from baseline visit
6 diarrhealiquid stools 2day
7 constipation
8 gasbloating
9 feverchills
10 scheduled or unscheduled visits for health care
To monitor for increased risk of safety concerns we will also inquire on follow up visits and phone calls about the following
1 household member with immunosuppression such as HIV or chemotherapy
On visits to the clinic we will evaluate lung function by spirometry
1 change in lung function with spirometry
2 women of childbearing potential will have repeat urine pregnancy testing at each clinic visit
3 intestinal barrier function
4 intestinal flora
5 serum inflammatory cytokines and IgE
1 the number of days with asthma related symptoms of cough wheeze dyspnea awakening at night and exercise limitation
2 the number of asthma-related missed schoolwork days
3 the amount of use of asthma rescue medications
4 use of non-inhaled steroids
5 change in medications from baseline visit
6 diarrhealiquid stools 2day
7 constipation
8 gasbloating
9 feverchills
10 scheduled or unscheduled visits for health care
To monitor for increased risk of safety concerns we will also inquire on follow up visits and phone calls about the following
1 household member with immunosuppression such as HIV or chemotherapy
On visits to the clinic we will evaluate lung function by spirometry
1 change in lung function with spirometry
2 women of childbearing potential will have repeat urine pregnancy testing at each clinic visit
3 intestinal barrier function
4 intestinal flora
5 serum inflammatory cytokines and IgE
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R21AT004089-01A1 | NIH | None | httpsreporternihgovquickSearch1R21AT004089-01A1 |