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.

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.

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome; Abdominal Pain; Dysbiosis; Post-Acute COVID-19 Syndrome
• Intervention / Treatment: Dietary supplement: Curcuma longa and Boswellia serrata extracts

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • PV
    • Pavia, PV, Italy, 27100
      • Mariangela Rondanelli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PCIBS Group; Participants with post-acute COVID-19 irritable bowel syndrome (PCIBS) supplemented with lecithin-based formulations of Curcuma longa (Meriva™) and Boswellia serrata (Casperome™) extracts.	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.
Active Comparator: IBS Control Group; Participants with irritable bowel syndrome (IBS) without prior COVID-19 infection supplemented with lecithin-based formulations of Curcuma longa (Meriva™) and Boswellia serrata (Casperome™) extracts.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Azienda di Servizi alla Persona di Pavia
• Investigators: Principal Investigator: Giacosa Attilio, Italian Diagnostic Center (CDI)

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): October 1, 2021
• Study Completion (Actual): June 10, 2022

Study Registration Dates

• First Submitted: May 16, 2024
• First Submitted That Met QC Criteria: May 16, 2024
• First Posted (Actual): May 21, 2024

Study Record Updates

• Last Update Posted (Actual): May 23, 2024
• Last Update Submitted That Met QC Criteria: May 22, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: abdominal pain; Bloating; Dysbiosis; Long Covid; Covid-19 infection; Boswellia serrata; Curcuma longa; IBS (irritable bowel syndrome)
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Pain; Neurologic Manifestations; Disease Attributes; Disease; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Chronic Disease; Post-Infectious Disorders; COVID-19; Syndrome; Irritable Bowel Syndrome; Abdominal Pain; Dysbiosis; Post-Acute COVID-19 Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants; Turmeric extract
• Other Study ID Numbers: 0912/09052020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No