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

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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Key information

Conditions

Boswellia Serrata Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Dysbiosis Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mariangela Rondanelli

Pavia, PV, 27100, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Low Foodmap diet

Other

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

Primary outcomes

Evaluate the effect of Lecithin formulation on small bowel dysbiosis

Time frame: from baseline to 30 days

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.

Sponsors and collaborators

Lead sponsor

Azienda di Servizi alla Persona di Pavia

Other

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: May 9, 2024
Registry last updated: May 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed