Functional Diarrhea
Conditions
Interventions
Double-blind, randomized, placebo-controlled clinical trial. Eighty participants will be randomized to receive for 12 weeks supplementation with a probiotic composed of a mixture of probiotic strains
G07.203.300.456.500
Sponsors
Farmoquímica S/A DIVCOM S/A
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Eligibility
Sex/Gender
Female
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Aged between 18 and 60 years; diagnosed with constipation or diarrhea or Irritable bowel syndrome as per Rome Foundation "Rome IV" criteria (Appendix 3); BMI between 18.5 and 29.9 Kg/m2.
Exclusion criteria
Exclusion criteria: Severe psychiatric diagnoses; confirmed medical diagnoses of gastrointestinal tract disorders (such as Crohn's disease and ulcerative colitis; celiac disease; small intestinal bacterial overgrowth); type I or II diabetes mellitus; history of gastrointestinal surgery; conditions that are known to cause changes in the gut microbiota (for example, opioid use, drug or alcohol abuse); if they are pregnant; breastfeeding; undergoing cancer treatment; taking laxatives; recently use of (in the last three months) probiotics (except for dairy and yogurt consumption) or symbiotics; other medications or supplements that are known to affect intestinal movement (for example, antispasmodics, antidepressants, antacids); antibiotics.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find a 25% reduction in gastrointestinal symptoms between the probiotic group when compared to the placebo, which will be measured at each visit, by applying the validated Portuguese version of the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire, which investigates symptoms related to five different domains (abdominal pain, reflux syndrome, diarrhea, indigestion, and constipation). | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to find differences in the composition of the intestinal microbiota between the group supplemented with probiotics and the placebo group. The expected differences refer to richness, microbial diversity, and an increase in the relative abundance of species related to intestinal health. ;It is expected to find a 30% difference in fecal zonulin concentration between the probiotic and placebo groups after the intervention (higher in the placebo group). Fecal zonulin is a marker of increased intestinal permeability. ;It is expected to find a 20% increase in intestinal metabolites (short-chain fatty acids) between the probiotic group compared to the placebo. | — |
Countries
Brazil
Contacts
Public ContactDan Waitzberg
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Outcome results
None listed