Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06423586
Status:
COMPLETED
Last Update Posted:
2024-05-23
First Post:
2024-05-16
Brief Title:
Effect of Lecithin-based Curcuma and Boswellia on Post-acute COVID-19 IBS
Sponsor:
Azienda di Servizi alla Persona di Pavia
Organization:
Azienda di Servizi alla Persona di Pavia
Study Overview
Official Title:
Positive Effect of Lecithin-based Delivery Form of Curcuma and Boswellia Extracts on Post-acute COVID-19 Irritable Bowel Syndrome Two Cohorts of an Open-label Study
Status:
COMPLETED
Status Verified Date:
2024-05
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:
This open-label study investigates the effects of lecithin-based formulations of Curcuma longa Meriva and Boswellia serrata Casperome extracts on post-acute COVID-19 irritable bowel syndrome PCIBS and irritable bowel syndrome IBS without prior COVID-19 infection A total of 44 participants 16 with PCIBS and 28 controls with IBS were supplemented for 30 days Outcomes measured included abdominal bloating abdominal pain enteral dysbiosis and global assessment of efficacy The study found significant reductions in bloating and pain in both groups with a notable decrease in dysbiosis only in the IBS group This suggests potential benefits of the supplementation in managing gastrointestinal symptoms associated with PCIBS and IBS
Detailed Description:
This study aims to evaluate the efficacy and safety of lecithin-based formulations of Curcuma longa Meriva and Boswellia serrata Casperome extracts in treating gastrointestinal symptoms in patients with post-acute COVID-19 irritable bowel syndrome PCIBS and irritable bowel syndrome IBS without prior COVID-19 infection The study was conducted at the Department of Public Health of the University of Pavia Italy Participants included 16 PCIBS patients and 28 IBS controls aged 18-75 years They were administered 500 mg of Curcuma longa and 150 mg of Boswellia serrata extracts twice daily for 30 days in conjunction with a low FODMAP diet Key outcomes measured were reductions in abdominal bloating and pain changes in enteral dysbiosis as indicated by urinary indican levels and overall treatment efficacy as assessed by participants The study found that both groups experienced significant reductions in abdominal bloating and pain However a notable decrease in enteral dysbiosis was observed only in the IBS control group The treatment was well tolerated with no reported adverse effects These findings suggest that the combination of Curcuma longa and Boswellia serrata extracts may provide significant benefits in managing gastrointestinal symptoms associated with PCIBS and IBS
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