Constipation
Conditions
Interventions
J02.500.456.249
A clinical supplementation study will be conducted to compare effects of prebiotic dietary fiber with a probiotic for modulating gut microbiota and promoting gut health. The study will be triple-blind
G07.203.300.456
Sponsors
Hospital de Clínicas da Universidade Federal do Paraná
RiteCarbs LLC
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: age older than 18 years; eutrophic or overweight with body mass index between 18.5 and 29.9 kg/m²; with I rritable Bowel Syndrome C symptoms according to Rome IV criteria; with complete primary education
Exclusion criteria
Exclusion criteria: other gastrointestinal diseases; kidney disease; liver diseases; gastrointestinal tract surgery; allergies to gluten and lactose; have used antibiotics or prebiotics or probiotics or symbiotics in the last 4 weeks; scleroderma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the gastrointestinal tolerance and the ability of the prebiotic to alleviate symptoms of IBS-C (Irritable Bowel Syndrome with constipation predominance), in comparison to the probiotic Lactobacillus rhamnosus GG - The assessment of gastrointestinal symptoms will be conducted using previously developed questionnaires that include the Gastrointestinal Symptom Rating Scale (GSRS), the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS), and the Bristol Stool Scale. These questionnaires will be administered before and after each supplementation period (weeks 0, 4, 8, 12, and 24). | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effect of prebiotic supplementation on the quality of life of participants with IBS and compare it to the probiotic Lactobacillus rhamnosus GG - Potential changes in quality of life will be assessed using an appropriate questionnaire, previously validated for this population (IBS-QOL - Irritable Bowel Syndrome Quality of Life survey). The IBS-QOL questionnaire will be administered before and after each supplementation period (weeks 0, 4, 8, 12, and 24).;To assess the effect of prebiotic supplementation on serum markers of intestinal barrier integrity and compare it to the probiotic Lactobacillus rhamnosus GG - The function of the intestinal barrier will be evaluated through ELISA, using specific kits to measure zonulin, a marker of paracellular permeability. Additional complementary analyses of intestinal barrier function may be performed, including the quantification of serum intestinal fatty acid-binding protein (I-FABP), LPS, LPS-binding protein, and bacterial DNA in the blood by PCR. These analyses will be conducted before and after each supplementation period (weeks 0, 4, 8, 12, and 24).;To assess the effect of prebiotic supplementation on markers of local (fecal) and systemic (serum) inflammation and compare it to the probiotic Lactobacillus rhamnosus GG - Intestinal inflammation will be evaluated using fecal calprotectin with specific kits. Systemic inflammation will be assessed by the dosage of IL-6 using specific ELISA kits. Additional complementary analyses may include the measurement of serum cytokines (IFN-?, IL-1ß, IL-2, IL-4, IL-8, IL-10, IL-12p70, IL-13, and TNF-a) and untargeted metabolomic analysis of the blood. These analyses will be carried out before and after each supplementation period (weeks 0, 4, 8, 12, and 24). | — |
Countries
Brazil
Contacts
Public ContactEstela Rabito
Hospital de Clínicas da Universidade Federal do Paraná
Outcome results
None listed