Diarrhea, Irritable Bowel Syndrome
Conditions
Keywords
intestinal microbiota, intestinal permeability, intestinal inflammation
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.
Interventions
DIETARY_SUPPLEMENTARBOX (QUEBRACHO AND CHESNUT EXTRACT)
ARBOX TWICE A DAY FOR 60 days
Sponsors
SILVATEAM
Hospital de Clinicas José de San Martín
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
before- after study
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Irritable bowel syndrome symptoms severity (IBS severity score, 75-500) | 60 days | Change in IBS severity score from baseline |
| Change in Stool frequency (number of deposition per day) | 60 days | Change in stool frequency per day from baseline |
| Change in Stool consistency (Bristol stool form scale, 1-7) | 60 days | Change in Stool consistency from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Inflammation | 60 days | serum cytokine level change from baseline. Bioplex Biorad |
| Change in Intestinal permeability | 60 days | Change in Anti Zonuline level from baseline |
| Change in Intestinal microbiota | 60 days | change in 16-s sequency from baseline |
Countries
Argentina
Outcome results
None listed