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

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

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.

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome; Diarrhea
• Intervention / Treatment: Dietary supplement: ARBOX (QUEBRACHO AND CHESNUT EXTRACT)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, B1622
    • Hospital de Clinicas Jose de San Martin. Buenos Aires University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IBS PATIENTS; Natural specific tannin, chestnut	Dietary supplement: ARBOX (QUEBRACHO AND CHESNUT EXTRACT); ARBOX TWICE A DAY FOR 60 days

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital de Clinicas José de San Martín
• Collaborators: SILVATEAM
• Investigators: Principal Investigator: MARIA MARTA PISKORZ, NEUROGASTROENTEROLOGIA HOSPITAL DE CLINICAS

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2021
• Primary Completion (Actual): February 20, 2022
• Study Completion (Actual): April 20, 2022

Study Registration Dates

• First Submitted: December 9, 2021
• First Submitted That Met QC Criteria: January 13, 2022
• First Posted (Actual): January 26, 2022

Study Record Updates

• Last Update Posted (Actual): July 6, 2022
• Last Update Submitted That Met QC Criteria: July 4, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: intestinal microbiota; intestinal inflammation; intestinal permeability
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Diarrhea
• Other Study ID Numbers: 25130271

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