Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06317441
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-02-27
Brief Title:
The Safety and Efficacy of a Probiotic Intervention on SIBO and Related Gastrointestinal Symptoms
Sponsor:
Nimble Science Ltd
Organization:
Nimble Science Ltd
Study Overview
Official Title:
The Safety and Efficacy of a Probiotic Intervention on SIBO and Related Gastrointestinal Symptoms
Status:
RECRUITING
Status Verified Date:
2024-07
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:
The goal of this study is to test the effect of a probiotic formulation on gastrointestinal symptoms gut and small intestine microbiota in participants suffering from small intestinal bacterial overgrowth SIBO Two doses of probiotic will be evaluated against placebo
Detailed Description:
The goal of this double-blinded randomized placebo-controlled clinical study is to evaluate whether two different doses of a probiotic formulation may have effect on gastrointestinal symptoms as well as gut and small intestine microbiota in participats suffering from SIBO The two probiotic doses will be compared to a placebo
The main research questions to be answered by this study are related to
Probiotic effect on bloating and abdominal distension
Probiotic effect on other gastrointestinal symptoms
Probiotic effect on incidence of SIBO
Probiotic effect on small intestine and gut microbiota
The study will include a 2 month intervention with the investigational products and assessments will be conducted at baseline mid-intervention end-of-intervention and follow-up period with the exception of SIBO diagnosis which will be conducted at baseline and at follow-up
The main research questions to be answered by this study are related to
Probiotic effect on bloating and abdominal distension
Probiotic effect on other gastrointestinal symptoms
Probiotic effect on incidence of SIBO
Probiotic effect on small intestine and gut microbiota
The study will include a 2 month intervention with the investigational products and assessments will be conducted at baseline mid-intervention end-of-intervention and follow-up period with the exception of SIBO diagnosis which will be conducted at baseline and at follow-up
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None