Trials / Completed
CompletedNCT06423586
Effect of Lecithin-based Curcuma and Boswellia on Post-acute COVID-19 IBS
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 44 (actual)
- Sponsor
- Azienda di Servizi alla Persona di Pavia · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Curcuma longa and Boswellia serrata extracts | Participants received 500 mg of Curcuma longa and 150 mg of Boswellia serrata extracts (Meriva™ and Casperome™) twice daily for 30 days. |
Timeline
- Start date
- 2021-09-01
- Primary completion
- 2021-10-01
- Completion
- 2022-06-10
- First posted
- 2024-05-21
- Last updated
- 2024-05-23
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT06423586. Inclusion in this directory is not an endorsement.