Effect of Lecithin-based Curcuma and Boswellia on Post-acute COVID-19 IBS

Irritable Bowel Syndrome Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06423586
• Other study ID #: 0912/09052020
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: June 10, 2022

Study information

• Verified date: May 2024
• Source: Azienda di Servizi alla Persona di Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 10, 2022
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age: 18-75 years, male or female.
• Diagnosis of post-acute COVID-19 irritable bowel syndrome (PCIBS) 60-120 days after the end of infection.
• Diagnosis of irritable bowel syndrome (IBS) without prior COVID-19 infection.
• Evidence of functional abdominal bloating/distention (FAB/D) type of IBS according to Mearin et al.
• Presence of enteral dysbiosis defined by increased urinary indican values with normal skatole urinary concentration.

Exclusion Criteria:

• Normal urinary indican values or increased urinary skatole values.
• Subjects already on a low FODMAP diet or other dietary restrictions such as gluten-free diet or lactose-free diet within the past 6 months.
• Allergies to soy, nuts, or seafood, or insulin-dependent diabetes.
• Known history of celiac disease, symptomatic diverticular disease, inflammatory bowel disease, or microscopic colitis.
• Prior small bowel or colonic surgery or cholecystectomy.
• Presence of bloody diarrhea or severe vomiting.
• Severe renal disease (serum creatinine >1.5 mg/dL) or liver disease (altered liver function tests).

Related Conditions & MeSH terms

• Abdominal Pain
• COVID-19
• Dysbiosis
• Irritable Bowel Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Italy	Mariangela Rondanelli	Pavia	PV

Sponsors (1)

Lead Sponsor	Collaborator
Azienda di Servizi alla Persona di Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Secondary	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