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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-03

Study Completion Date

2023-03-03

Brief Summary

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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.

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Detailed Description

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Conditions

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Boswellia Serrata Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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CUBO and low FODMAP diet (Intervention)

Curcuma and Boswellia serrata extract plus a Low Fodmap Diet

Group Type ACTIVE_COMPARATOR

Curcuma and boswellia extracts plus low fodmap diet

Intervention Type DIETARY_SUPPLEMENT

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

LFD (Control)

Only Low Fodmap Diet

Group Type OTHER

Low Foodmap diet

Intervention Type OTHER

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

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Low Foodmap diet

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes