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Irritable Bowel SyndromeNCT05207618

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

A study testing ARBOX (QUEBRACHO AND CHESNUT EXTRACT) in people with Irritable Bowel Syndrome and Diarrhea, run by Hospital de Clinicas José de San Martín at 1 site in Argentina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Irritable Bowel Syndrome, Diarrhea
What is being tested?
ARBOX (QUEBRACHO AND CHESNUT EXTRACT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteArgentina
Study dates
21 Sep 2021to 20 Apr 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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,
Show all 11Show fewer
  • celiac disease,
  • patients with cognitive impairment,
  • alcoholics,
  • lack of consent .
  • patients who have received antibiotics in the last month.

Trial locations and contacts

1 site in 1 country.

Argentina1 site

  • Hospital de Clinicas Jose de San Martin. Buenos Aires University

    Buenos Aires, B1622

Other trials in Argentina

About this study

Official title: Utility of the Administration of Tannin Specific Natural Extract, Chesnut and Quebracho Based, 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.

Read the 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.

Being tested
ARBOX (QUEBRACHO AND CHESNUT EXTRACT)
Keywords
intestinal microbiota, intestinal permeability, intestinal inflammation
Medical subject headings
Irritable Bowel Syndrome, Diarrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ARBOX (QUEBRACHO AND CHESNUT EXTRACT)Dietary supplement

    ARBOX TWICE A DAY FOR 60 days

Study groups in NCT05207618
Study groupRoleWhat they receive
IBS PATIENTSExperimentalNatural specific tannin, chestnut
Receives: Dietary Supplement: ARBOX (QUEBRACHO AND CHESNUT EXTRACT)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Change in IBS severity score from baseline

    Measured: 60 days

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

    Change in stool frequency per day from baseline

    Measured: 60 days

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

    Change in Stool consistency from baseline

    Measured: 60 days

Secondary outcomes (3)

  1. Change in Inflammation

    serum cytokine level change from baseline. Bioplex Biorad

    Measured: 60 days

  2. Change in Intestinal permeability

    Change in Anti Zonuline level from baseline

    Measured: 60 days

  3. Change in Intestinal microbiota

    change in 16-s sequency from baseline

    Measured: 60 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2022
  2. Study start21 Sep 2021
  3. Primary completion20 Feb 2022
  4. Study completion20 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
before- after study
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05207618
Sponsor's protocol ID
25130271
Status last verified
Jul 2022
First submitted
9 Dec 2021
Last updated
6 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 42003449

Questions about this trial

What is this clinical trial studying?

A study testing ARBOX (QUEBRACHO AND CHESNUT EXTRACT) in people with Irritable Bowel Syndrome and Diarrhea, run by Hospital de Clinicas José de San Martín at 1 site in Argentina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Irritable bowel syndrome symptoms severity (IBS severity score, 75-500) (time frame: 60 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05207618, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022.

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