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This open-label study investigates the effects of lecithin-based formulations of Curcuma longa (Merivaâ„¢) and Boswellia serrata (Casperomeâ„¢) 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.
This study aims to evaluate the efficacy and safety of lecithin-based formulations of Curcuma longa (Merivaâ„¢) and Boswellia serrata (Casperomeâ„¢) 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCIBS Group | Experimental | Participants with post-acute COVID-19 irritable bowel syndrome (PCIBS) supplemented with lecithin-based formulations of Curcuma longa (Merivaâ„¢) and Boswellia serrata (Casperomeâ„¢) extracts. |
|
| IBS Control Group | Active Comparator | Participants with irritable bowel syndrome (IBS) without prior COVID-19 infection supplemented with lecithin-based formulations of Curcuma longa (Merivaâ„¢) and Boswellia serrata (Casperomeâ„¢) extracts. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Curcuma longa and Boswellia serrata extracts | Dietary Supplement | Participants received 500 mg of Curcuma longa and 150 mg of Boswellia serrata extracts (Merivaâ„¢ and Casperomeâ„¢) twice daily for 30 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Abdominal Bloating | Measure the change in abdominal bloating severity from baseline to the end of the study using a validated questionnaire. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Urinary Indican Levels | Evaluate the change in urinary indican levels from baseline to the end of the study to assess enteral dysbiosis | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Global Assessment of Efficacy (GAE) | Assess the overall efficacy of the treatment using a 4-point scale (ineffective, moderately effective, effective, very effective). | 30 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giacosa Attilio | Italian Diagnostic Center (CDI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mariangela Rondanelli | Pavia | PV | 27100 | Italy |
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| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| D043183 | Irritable Bowel Syndrome |
| D015746 | Abdominal Pain |
| D064806 | Dysbiosis |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C012596 | turmeric extract |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |