Utility of the Administration of Chesnut and Quebracho Ex... | NCT05207618

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

NCT05207618

Sponsor

Hospital de Clinicas José de San Martín

Status

Completed

Last Update Posted

Jul 6, 2022Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Irritable Bowel Syndrome
Diarrhea

Interventions

ARBOX (QUEBRACHO AND CHESNUT EXTRACT)

Countries

Argentina

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 21, 2021Actual

Primary Completion Date

Feb 20, 2022Actual

Completion Date

Apr 20, 2022Actual

First Submitted Date

Dec 9, 2021

First Submission Date that Met QC Criteria

Jan 13, 2022

First Posted Date

Jan 26, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 4, 2022

Last Update Posted Date

Jul 6, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Maria Marta Piskorz, Neurogastroenterologist at Hospital de Clinicas, Principal Investigator, Hospital de Clinicas José de San MartínPrincipal Investigator

Lead Sponsor

Hospital de Clinicas José de San MartínOTHER

Collaborators

Name	Class
SILVATEAM	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IBS PATIENTS	Experimental	Natural specific tannin, chestnut	Dietary Supplement: ARBOX (QUEBRACHO AND CHESNUT EXTRACT)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ARBOX (QUEBRACHO AND CHESNUT EXTRACT)	Dietary Supplement	ARBOX TWICE A DAY FOR 60 days	IBS PATIENTS

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
MARIA MARTA PISKORZ	NEUROGASTROENTEROLOGIA HOSPITAL DE CLINICAS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital de Clinicas Jose de San Martin. Buenos Aires University		Buenos Aires		B1622	Argentina

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
42003449	Derived	Molino S, Piskorz MM, Lerma-Aguilera A, Mingorance FL, Gutierrez C, Montero JM, Uehara T, Hashimoto H, Ballerga EG, Olmos JA. Tannin Phytocomplex Improves IBS-D Symptoms and Gut-Brain Markers: Prospective Pilot Study. Mol Nutr Food Res. 2026 Apr;70(8):e70451. doi: 10.1002/mnfr.70451.

ID	Term
D003109	Colonic Diseases, Functional
D003108	Colonic Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases

ID	Term
D043183	Irritable Bowel Syndrome
D003967	Diarrhea