Utility of the Administration of Chesnut and Quebracho Extract for Irritable Bowel Syndrome Diarrhea Predominant

Study Overview
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Brief Summary
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Irritable bowel syndrome is a highly prevalent disorder and consumes many health resources. Its physiopathogenesis is multifactorial. Some of the factors involved have to do with the alteration of the intestinal microbiota, low-grade inflammation and the alteration of intestinal permeability. Specific tannins have been shown to have prebiotic effects and could be useful in treating this condition. This is an exploratory before-after study that aims to evaluate the effect of a chestnut and quebracho extract on the symptoms of IBS diarrhea predominant, serum cytokine levels, microbiota and intestinal permeability, as well as on metabolomics.

Detailed Description
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In vitro studies have shown that chestnut and quebracho extract has a prebiotic effect of modulating the intestinal microbiota, but also, bacterial fermentation produces metabolites with powerful anti-inflammatory effects such as quecetin. Irritable bowel syndrome (IBS) is a multifactorial disorder involving factors related to the intestinal microbiota, low-grade inflammation, and impaired intestinal permeability. In this study, 30 patients with predominant IBS diarrhea and 50 healthy controls will be included. IBS patients will receive chestnut and quebracho extract twice a day for 8 weeks. They will be measured at baseline and at 8 weeks: 27 serum pro and anti-inflammatory cytokines and serum zonulin. Likewise, the intestinal microbiota and metabolomics will be evaluated.

Official Title
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Utility of the Administration of Tannin Specific Natural Extract, Chesnut and Quebracho Based, for Irritable Bowel Syndrome Diarrhea Predominant

Conditions
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Irritable Bowel Syndrome, Diarrhea

Intervention / Treatment
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* Dietary Supplement: ARBOX (QUEBRACHO AND CHESNUT EXTRACT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: IBS patients: Both sexes with a diagnosis of irritable bowel syndrome variety diarrhea according to the Rome IV criteria Healthy Controls: Relatives of patients who do not show any disease, who do not take medication or present symptoms. Exclusion Criteria: patients with digestive tract disease, systemic diseases such as severe heart, kidney or liver failure, history of previously known digestive tract surgeries and / or intestinal adhesions, diabetes mellitus, cirrhosis, inflammatory bowel disease, celiac disease, patients with cognitive impairment, alcoholics, lack of consent . patients who have received antibiotics in the last month.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: before- after study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IBS PATIENTS<br>Natural specific tannin, chestnut | Dietary Supplement: ARBOX (QUEBRACHO AND CHESNUT EXTRACT)<br>* ARBOX TWICE A DAY FOR 60 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Irritable bowel syndrome symptoms severity (IBS severity score, 75-500) | Change in IBS severity score from baseline | 60 days | 
| Change in Stool frequency (number of deposition per day) | Change in stool frequency per day from baseline | 60 days | 
| Change in Stool consistency (Bristol stool form scale, 1-7) | Change in Stool consistency from baseline | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Inflammation | serum cytokine level change from baseline. Bioplex Biorad | 60 days | 
| Change in Intestinal permeability | Change in Anti Zonuline level from baseline | 60 days | 
| Change in Intestinal microbiota | change in 16-s sequency from baseline | 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intestinal microbiota, intestinal permeability, intestinal inflammation