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Prebiotic and Anti-inflammatory Effects of a Pectin Polysaccharide

Ö

Örebro University, Sweden

Status

Completed

Conditions

Healthy

Treatments

Other: Fermented product of carrot derived rhamnogalacturonan I

Study type

Interventional

Funder types

Other

Identifiers

NCT05421793
2022-01814-02

Details and patient eligibility

About

The aim of this study is to determine, quantify and understand the potential prebiotic and anti-inflammatory effects of the pecticpolysaccharide rhamnogalacturonan I (RG-I). The effects of these dietary fibre fractions on barrier function will also be investigated.

Full description

The dietary fibre fractions from RG-I will be tested first for their prebiotic potential. Batch culture fermentation systems containing basal growth medium will be inoculated with faecal homogenates obtained from different time points (Task I) and will be used for analyzing microbiota composition and microbiota-associated metabolites. Subsequently, the collection of colon biopsies through sigmoidoscopy procedure of the same subjects will take place and the collected biopsies will be mounted in Ussing Chambers. Supernatants collected from Task I will be added to the mucosal side of the biopsy together with a stressor and two permeability markers, in order to investigate the effects of the fibre fractions on both paracellular and transcellular permeability.Throughout the study subjects will complete questionnaires related to their gastrointestinal health and dietary habits

Enrollment

17 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Signed consent prior to any study related procedures
  2. Age 18-65 years
  3. Willing to abstain from regular consumption of prebiotics/probiotics products or medication known to alter gastrointestinal functions at least 4 weeks prior to the study visits

Exclusion criteria

  1. Previous complicated gastrointestinal surgery
  2. Presence of gastrointestinal disorder or any disorder which the principal investigator considers to affect the results of the study
  3. Current diagnosis of psychiatric disease
  4. Current and past diagnosis inflammatory gastrointestinal disease (e.g. Irritable Bowel Disease)
  5. Systemic use of antibiotics or steroids medications in the last 3 months
  6. Frequent use of NSAID (Non Steroidal Anti Inflammatory Drugs) the last 2 months prior to study visits
  7. Regular consumption of prebiotic/probiotic products for the past 4 weeks
  8. Abuse of alcohol or drugs
  9. Frequent use of laxatives, anti-diarrheal, anti-cholinergic within last 12 weeks prior to study visits
  10. Pregnancy and breast-feeding

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

17 participants in 1 patient group

Gut barrier function treatments
Experimental group
Description:
Stressor, fibre, combination of treatments.
Treatment:
Other: Fermented product of carrot derived rhamnogalacturonan I

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Robert Brummer, Professor; Ignacio Rangel, As.Professor

Data sourced from clinicaltrials.gov

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