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

Primary Purpose

Irritable Bowel Syndrome, Diarrhea

Status

Completed

Phase

Not Applicable

Locations

Argentina

Study Type

Interventional

Intervention

ARBOX (QUEBRACHO AND CHESNUT EXTRACT)

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring intestinal microbiota, intestinal permeability, intestinal inflammation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Hospital de Clinicas Jose de San Martin. Buenos Aires University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IBS PATIENTS

Arm Description

Natural specific tannin, chestnut

Outcomes

Primary Outcome Measures

Change in Irritable bowel syndrome symptoms severity (IBS severity score, 75-500)

Change in IBS severity score from baseline

Change in Stool frequency (number of deposition per day)

Change in stool frequency per day from baseline

Change in Stool consistency (Bristol stool form scale, 1-7)

Change in Stool consistency from baseline

Secondary Outcome Measures

Change in Inflammation

serum cytokine level change from baseline. Bioplex Biorad

Change in Intestinal permeability

Change in Anti Zonuline level from baseline

Change in Intestinal microbiota

change in 16-s sequency from baseline

Full Information

NCT ID

NCT05207618

First Posted

December 9, 2021

Last Updated

July 4, 2022

Sponsor

Hospital de Clinicas José de San Martín

Collaborators

SILVATEAM

1. Study Identification

Unique Protocol Identification Number

NCT05207618

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

September 21, 2021 (Actual)

Primary Completion Date

February 20, 2022 (Actual)

Study Completion Date

April 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital de Clinicas José de San Martín

Collaborators

SILVATEAM

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Irritable Bowel Syndrome, Diarrhea

Keywords

intestinal microbiota, intestinal permeability, intestinal inflammation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

before- after study

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IBS PATIENTS

Arm Type

Experimental

Arm Description

Natural specific tannin, chestnut

Intervention Type

Dietary Supplement

Intervention Name(s)

ARBOX (QUEBRACHO AND CHESNUT EXTRACT)

Intervention Description

ARBOX TWICE A DAY FOR 60 days

Primary Outcome Measure Information:

Title

Change in Irritable bowel syndrome symptoms severity (IBS severity score, 75-500)

Description

Change in IBS severity score from baseline

Time Frame

60 days

Title

Change in Stool frequency (number of deposition per day)

Description

Change in stool frequency per day from baseline

Time Frame

60 days

Title

Change in Stool consistency (Bristol stool form scale, 1-7)

Description

Change in Stool consistency from baseline

Time Frame

60 days

Secondary Outcome Measure Information:

Title

Change in Inflammation

Description

serum cytokine level change from baseline. Bioplex Biorad

Time Frame

60 days

Title

Change in Intestinal permeability

Description

Change in Anti Zonuline level from baseline

Time Frame

60 days

Title

Change in Intestinal microbiota

Description

change in 16-s sequency from baseline

Time Frame

60 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

MARIA MARTA PISKORZ

Organizational Affiliation

NEUROGASTROENTEROLOGIA HOSPITAL DE CLINICAS

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital de Clinicas Jose de San Martin. Buenos Aires University

City

Buenos Aires

ZIP/Postal Code

B1622

Country

Argentina

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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