Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06346847
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-03-29
Brief Title:
Study to Assess Effects of Postbiotic vs Placebo in Participants With Diarrhea-predominant IBS
Sponsor:
A-Mansia Biotech SA
Organization:
A-Mansia Biotech SA
Study Overview
Official Title:
A Randomized Double Blind Placebo Controlled Parallel Group Clinical Study to Assess Effects of Postbiotic vs Placebo in Participants With Moderate to Severe Diarrhea-predominant Irritable Bowel Syndrome
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
PAM-DIGEST
Brief Summary:
The present study is a randomized double-blind placebo-controlled parallel group clinical study that assesses the effect of postbioc on the complaints of subjects with moderate to severe diarrhoea-predominant irritable bowel syndrome IBS-D The trial is also evaluating the potential of postbiotic on anxiety low mood and stress of the participants as well as its safety and tolerability
The intervention duration for all the study participants is 12 weeks intervention phase Subsequently the participants will be invited to return to site for an end of study assessment after 21 days of no intervention post-intervention phase
The intervention duration for all the study participants is 12 weeks intervention phase Subsequently the participants will be invited to return to site for an end of study assessment after 21 days of no intervention post-intervention phase
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IBS-D PAM | Other Identifier | The Akkermansia Company | None |