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Completed

NCT Number: NCT05207618

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Clinicas Jose de San Martin. Buenos Aires University

Buenos Aires, B1622, Argentina

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ARBOX (QUEBRACHO AND CHESNUT EXTRACT)

Dietary Supplement

ARBOX TWICE A DAY FOR 60 days

Primary outcomes

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

    Time frame: 60 days

    Change in IBS severity score from baseline

  2. Change in Stool frequency (number of deposition per day)

    Time frame: 60 days

    Change in stool frequency per day from baseline

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

    Time frame: 60 days

    Change in Stool consistency from baseline

Secondary outcomes

  1. Change in Inflammation

    Time frame: 60 days

    serum cytokine level change from baseline. Bioplex Biorad

  2. Change in Intestinal permeability

    Time frame: 60 days

    Change in Anti Zonuline level from baseline

  3. Change in Intestinal microbiota

    Time frame: 60 days

    change in 16-s sequency from baseline

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas José de San Martín

Other

Collaborators

  • SILVATEAM

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 26, 2022
Registry last updated
Jul 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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