Clinical trial NCT05207618: 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
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Diarrhea
Keywords: intestinal microbiota
intestinal permeability
intestinal inflammation
Lead sponsor: Hospital de Clinicas José de San Martín
Sponsor class: OTHER
Collaborators: name: SILVATEAM
First posted: 2022-01-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: before- after study
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Irritable bowel syndrome symptoms severity (IBS severity score, 75-500)
timeFrame: 60 days
measure: Change in Stool frequency (number of deposition per day)
timeFrame: 60 days
measure: Change in Stool consistency (Bristol stool form scale, 1-7)
timeFrame: 60 days
Secondary outcomes:
measure: Change in Inflammation
timeFrame: 60 days
measure: Change in Intestinal permeability
timeFrame: 60 days
measure: Change in Intestinal microbiota
timeFrame: 60 days
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital de Clinicas Jose de San Martin. Buenos Aires University
Study officials:
affiliation: NEUROGASTROENTEROLOGIA HOSPITAL DE CLINICAS
name: MARIA MARTA PISKORZ
role: PRINCIPAL_INVESTIGATOR
References: