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

NCT ID: NCT05207618

Last Updated: 2022-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-21
• Study Completion Date: 2022-04-20

Brief Summary

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

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.

Conditions

Irritable Bowel Syndrome; Diarrhea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IBS PATIENTS

Natural specific tannin, chestnut

Group Type: EXPERIMENTAL

ARBOX (QUEBRACHO AND CHESNUT EXTRACT)

Intervention Type: DIETARY_SUPPLEMENT

ARBOX TWICE A DAY FOR 60 days

Interventions

ARBOX (QUEBRACHO AND CHESNUT EXTRACT)

ARBOX TWICE A DAY FOR 60 days

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

SILVATEAM

UNKNOWN

Sponsor Role: collaborator

Hospital de Clinicas José de San Martín

OTHER

Sponsor Role: lead

Responsible Party

Maria Marta Piskorz

Neurogastroenterologist at Hospital de Clinicas, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

MARIA MARTA PISKORZ

Role: PRINCIPAL_INVESTIGATOR

NEUROGASTROENTEROLOGIA HOSPITAL DE CLINICAS

Locations

Hospital de Clinicas Jose de San Martin. Buenos Aires University

Buenos Aires, , Argentina

Countries

Argentina

Other Identifiers

25130271

Identifier Type: -

Identifier Source: org_study_id