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

NCT06407609 | Completed

• 1 other identifier: 0612/22052019
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Boswellia Serrata; Irritable Bowel Syndrome

Keywords

Bloating; Dysbiosis; Boswellia serrata; Curcuma longa; Irritable bowel syndrome; Microbiota; Phytosome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

CUBO and low FODMAP diet (Intervention)

ACTIVE COMPARATOR

Curcuma and Boswellia serrata extract plus a Low Fodmap Diet

Dietary Supplement: Curcuma and boswellia extracts plus low fodmap diet

LFD (Control)

OTHER

Only Low Fodmap Diet

Other: Low Foodmap diet

Interventions

Curcuma and boswellia extracts plus low fodmap diet DIETARY_SUPPLEMENT

Low Foodmap diet + Curcuma and boswellia extracts both formulated in sunflower lecithin (Phytosome™) and processed with a strong commitment to sustainability

CUBO and low FODMAP diet (Intervention)

Low Foodmap diet OTHER

such as lactose or gluten free diet in the last 6 months

LFD (Control)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda di Servizi alla Persona di Pavia: lead

Study Sites (1)

Mariangela Rondanelli

Pavia, PV, 27100, Italy

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Dysbiosis

Interventions

turmeric extract; FODMAP Diet

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Elimination Diets; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: May 9, 2024
• Study Start: September 3, 2022
• Primary Completion: March 3, 2023
• Study Completion: March 3, 2023
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)