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

NCT ID: NCT06423586

Last Updated: 2024-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2022-06-10

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.

Conditions

Post-Acute COVID-19 Syndrome; Irritable Bowel Syndrome; Abdominal Pain; Dysbiosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Curcuma longa and Boswellia serrata extracts

Intervention Type: DIETARY_SUPPLEMENT

Participants received 500 mg of Curcuma longa and 150 mg of Boswellia serrata extracts (Meriva™ and Casperome™) twice daily for 30 days.

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.

Group Type: ACTIVE_COMPARATOR

Curcuma longa and Boswellia serrata extracts

Intervention Type: DIETARY_SUPPLEMENT

Participants received 500 mg of Curcuma longa and 150 mg of Boswellia serrata extracts (Meriva™ and Casperome™) twice daily for 30 days.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda di Servizi alla Persona di Pavia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giacosa Attilio

Role: PRINCIPAL_INVESTIGATOR

Italian Diagnostic Center (CDI)

Locations

Mariangela Rondanelli

Pavia, PV, Italy

Countries

Italy

Other Identifiers

0912/09052020

Identifier Type: -

Identifier Source: org_study_id