## Protocol Section
### Identification Module
**NCT ID:** NCT06423586

**Brief Title:** Effect of Lecithin-based Curcuma and Boswellia on Post-acute COVID-19 IBS

**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.

#### Organization Study ID Info
**ID:** 0912/09052020
#### Organization
**Class:** OTHER
**Full Name:** Azienda di Servizi alla Persona di Pavia
### Status Module
#### Completion Date
**Date:** 2022-06-10

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-10-01

**Type:** ACTUAL

#### Start Date
**Date:** 2021-09-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Azienda di Servizi alla Persona di Pavia

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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 Module

**Conditions:**

- Post-Acute COVID-19 Syndrome

- Irritable Bowel Syndrome

- Abdominal Pain

- Dysbiosis

**Keywords:**

- abdominal pain

- Bloating

- Boswellia serrata

- Covid-19 infection

- Curcuma longa

- Dysbiosis

- IBS (irritable bowel syndrome)

- Long Covid

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 44

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants with post-acute COVID-19 irritable bowel syndrome (PCIBS) supplemented with lecithin-based formulations of Curcuma longa (Meriva™) and Boswellia serrata (Casperome™) extracts.

**Intervention Names:**

- Dietary Supplement: Curcuma longa and Boswellia serrata extracts

**Label:** PCIBS Group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Dietary Supplement: Curcuma longa and Boswellia serrata extracts

**Label:** IBS Control Group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- IBS Control Group

- PCIBS Group

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

**Name:** Curcuma longa and Boswellia serrata extracts

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Other Outcomes

**Description:** Assess the overall efficacy of the treatment using a 4-point scale (ineffective, moderately effective, effective, very effective).

**Measure:** Global Assessment of Efficacy (GAE)

**Time Frame:** 30 days

#### Primary Outcomes

**Description:** Measure the change in abdominal bloating severity from baseline to the end of the study using a validated questionnaire.

**Measure:** Reduction in Abdominal Bloating

**Time Frame:** 30 days

#### Secondary Outcomes

**Description:** Evaluate the change in urinary indican levels from baseline to the end of the study to assess enteral dysbiosis

**Measure:** Change in Urinary Indican Levels

**Time Frame:** 30 days

### Eligibility Module

**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).

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Pavia

**Country:** Italy

**Facility:** Mariangela Rondanelli

**State:** PV

**Zip:** 27100

#### Overall Officials

**Official 1:**

**Affiliation:** Italian Diagnostic Center (CDI)

**Name:** Giacosa Attilio

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004194

- Term: Disease

- ID: D000010335

- Term: Pathologic Processes

- ID: D000011024

- Term: Pneumonia, Viral

- ID: D000011014

- Term: Pneumonia

- ID: D000012141

- Term: Respiratory Tract Infections

- ID: D000007239

- Term: Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000018352

- Term: Coronavirus Infections

- ID: D000003333

- Term: Coronaviridae Infections

- ID: D000030341

- Term: Nidovirales Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000003109

- Term: Colonic Diseases, Functional

- ID: D000003108

- Term: Colonic Diseases

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000012817

- Term: Signs and Symptoms, Digestive

- ID: D000094025

- Term: Post-Infectious Disorders

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: HIGH

- As Found: Syndrome

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M3013

- Name: Post-Acute COVID-19 Syndrome

- Relevance: HIGH

- As Found: Post-Acute COVID-19 Syndrome

- ID: M2561

- Name: COVID-19

- Relevance: HIGH

- As Found: COVID-19

- ID: M25118

- Name: Irritable Bowel Syndrome

- Relevance: HIGH

- As Found: Irritable Bowel Syndrome

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M18311

- Name: Abdominal Pain

- Relevance: HIGH

- As Found: Abdominal Pain

- ID: M30405

- Name: Dysbiosis

- Relevance: HIGH

- As Found: Dysbiosis

- ID: M13904

- Name: Pneumonia

- Relevance: LOW

- As Found: Unknown

- ID: M13914

- Name: Pneumonia, Viral

- Relevance: LOW

- As Found: Unknown

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M20490

- Name: Coronavirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6555

- Name: Coronaviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M23685

- Name: Nidovirales Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6336

- Name: Colonic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6337

- Name: Colonic Diseases, Functional

- Relevance: LOW

- As Found: Unknown

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M15622

- Name: Signs and Symptoms, Digestive

- Relevance: LOW

- As Found: Unknown

- ID: M3014

- Name: Post-Infectious Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000086382

- Term: COVID-19

- ID: D000094024

- Term: Post-Acute COVID-19 Syndrome

- ID: D000043183

- Term: Irritable Bowel Syndrome

- ID: D000013577

- Term: Syndrome

- ID: D000015746

- Term: Abdominal Pain

- ID: D000064806

- Term: Dysbiosis

### Intervention Browse Module - Ancestors

- ID: D000000975

- Term: Antioxidants

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000020011

- Term: Protective Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: HB

- Name: Herbal and Botanical

- Abbrev: Ot

- Name: Other Dietary Supplements

### Intervention Browse Module - Browse Leaves

- ID: M342247

- Name: Turmeric extract

- Relevance: HIGH

- As Found: Urodynamic study

- ID: M4292

- Name: Antioxidants

- Relevance: LOW

- As Found: Unknown

- ID: M21869

- Name: Protective Agents

- Relevance: LOW

- As Found: Unknown

- ID: T319

- Name: Turmeric

- Relevance: HIGH

- As Found: Urodynamic study

- ID: T198

- Name: Indian Frankincense

- Relevance: HIGH

- As Found: Coxsackievirus

- ID: T404

- Name: Lecithin

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000012596

- Term: Turmeric extract

### Misc Info Module

- Version Holder: 2024-05-31
