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

NCT05207618 | Completed

• 1 other identifier: 25130271
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome; Diarrhea

Keywords

intestinal microbiota; intestinal permeability; intestinal inflammation

Outcome Measures

Primary Outcomes (3)

• 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 (3)

• Change in Inflammation

  60 days

• Change in Intestinal permeability

  60 days

• Change in Intestinal microbiota

  60 days

Study Arms (1)

IBS PATIENTS

EXPERIMENTAL

Natural specific tannin, chestnut

Dietary Supplement: ARBOX (QUEBRACHO AND CHESNUT EXTRACT)

Interventions

ARBOX (QUEBRACHO AND CHESNUT EXTRACT) DIETARY_SUPPLEMENT

ARBOX TWICE A DAY FOR 60 days

IBS PATIENTS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas José de San Martín: lead
• SILVATEAM: collaborator

Study Sites (1)

Hospital de Clinicas Jose de San Martin. Buenos Aires University

Buenos Aires, B1622, Argentina

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Diarrhea

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• MARIA MARTA PISKORZ

  NEUROGASTROENTEROLOGIA HOSPITAL DE CLINICAS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurogastroenterologist at Hospital de Clinicas, Principal Investigator

Model Details: before- after study

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: January 26, 2022
• Study Start: September 21, 2021
• Primary Completion: February 20, 2022
• Study Completion: April 20, 2022
• Last Updated: July 6, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)