Positive Outcomes of the Supplementation With Lecithin-based Delivery Form of Curcuma Longa and of Boswellia Serrata in IBS

Positive Outcomes of the Supplementation With Lecithin-based Delivery Form of Curcuma Longa and of Boswellia Serrata in IBS Subjects With Small Bowel Dysbiosis

Small bowel dysbiosis (SBD), is a frequent finding in subjects with irritable bowel syndrome (IBS). The formula-tion in sunflower lecithin (Phytosome) of Curcuma longa and Boswellia serrata demonstrated beneficial effects on intestinal microbiota. The aim of this study was to evaluate the effect of a lecithin-based delivery formulation of Curcuma longa and of Boswellia serrata extracts (CUBO), on SBD in IBS subjects.

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome; Boswellia Serrata
• Intervention / Treatment: Dietary supplement: Curcuma and boswellia extracts plus low fodmap diet; Other: Low Foodmap diet

• Study Type: Interventional
• Enrollment (Actual): 64
• 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: Yes

Description

Inclusion Criteria:

• age ranging from 18 to 70 years;
• diagnosis of moderate IBS according to Rome IV criteria;
• dysbiosis of the small bowel, defined by increased urinary indican values with normal values of urinary skatole;
• evidence of abdominal bloating and abdominal pain

Exclusion Criteria:

• normal values of urinary indican or increased values of urinary skatole ;
• subjects who were already on a low FODMAP diet (LFD) or other dietary prescription, such as lactose or gluten free diet in the last 6 months;
• insulin-dependent diabetes or seafood, nuts or soy allergies ;
• positive history of symptomatic diverticular disease, celiac disease, inflammatory bowel disease or microscopic colitis;
• colonic or small bowel or gallbladder surgery ;
• severe vomiting or bloody diarrhea ;
• liver disease (defined as altered values of liver function tests) or severe renal disease (defined as serum creatinine >1.5 mg/dL) or treatment with antibiotics, excluding those for topical use, within the last three months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CUBO and low FODMAP diet (Intervention); Curcuma and Boswellia serrata extract plus a Low Fodmap Diet	Dietary supplement: Curcuma and boswellia extracts plus low fodmap diet; Low Foodmap diet + Curcuma and boswellia extracts both formulated in sunflower lecithin (Phytosome™) and processed with a strong commitment to sustainability
Other: LFD (Control); Only Low Fodmap Diet	Other: Low Foodmap diet; such as lactose or gluten free diet in the last 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the effect of Lecithin formulation on small bowel dysbiosis	The primary endpoint was the change of small bowel dysbiosis established by the decrease in urine indican values. The dysbiosis of the small bowel was defined by increased urinary indican values with normal values of urinary skatole. Urinary values of indican (3-indoxyl sulfate) were evaluated through a colorimetric method. Urinary indican was considered normal when the levels were lower than 10 mg/L.	from baseline to 30 days

Collaborators and Investigators

• Sponsor: Azienda di Servizi alla Persona di Pavia

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2022
• Primary Completion (Actual): March 3, 2023
• Study Completion (Actual): March 3, 2023

Study Registration Dates

• First Submitted: April 19, 2024
• First Submitted That Met QC Criteria: May 6, 2024
• First Posted (Actual): May 9, 2024

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Microbiota; Bloating; Irritable bowel syndrome; Dysbiosis; Boswellia serrata; Curcuma longa; Phytosome
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Irritable Bowel Syndrome
• Other Study ID Numbers: 0612/22052019

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