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

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05207618
• Other study ID #: 25130271
• Status: Completed
• Phase: N/A
• Start date: September 21, 2021
• Est. completion date: April 20, 2022

Study information

• Verified date: July 2022
• Source: Hospital de Clinicas José de San Martín
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 20, 2022
• Est. primary completion date: February 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diarrhea
• Irritable Bowel Syndrome
• Syndrome

Intervention

Dietary Supplement:
• ARBOX (QUEBRACHO AND CHESNUT EXTRACT)
ARBOX TWICE A DAY FOR 60 days

Locations

Country	Name	City	State
Argentina	Hospital de Clinicas Jose de San Martin. Buenos Aires University	Buenos Aires

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Clinicas José de San Martín	SILVATEAM

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Irritable bowel syndrome symptoms severity (IBS severity score, 75-500)	Change in IBS severity score from baseline	60 days
Primary	Change in Stool frequency (number of deposition per day)	Change in stool frequency per day from baseline	60 days
Primary	Change in Stool consistency (Bristol stool form scale, 1-7)	Change in Stool consistency from baseline	60 days
Secondary	Change in Inflammation	serum cytokine level change from baseline. Bioplex Biorad	60 days
Secondary	Change in Intestinal permeability	Change in Anti Zonuline level from baseline	60 days
Secondary	Change in Intestinal microbiota	change in 16-s sequency from baseline	60 days