Functional gastrointestinal disorders (FGIDs), in particular irritable bowel syndrome - diarrhea predominant form (IBS-D) Digestive System
Conditions
Interventions
The subjects recruited in the present clinical study will be randomized into the following experimental groups:
Group 1: Subjects will receive the food supplement, which contains a combination of prob
Sponsors
Schwabe Pharma Italia S.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Are aged between 18 and 70 years 2. Are able to understand and sign the informed consent 3. Have a negative HIV test 4. Have a negative pregnancy test 5. Exhibit symptoms of IBS-D for at least 3 months (with onset at least 6 months prior), characterized by recurrent abdominal pain occurring at least once per week, associated with two or more of the following criteria: pain associated with defecation, pain associated with a change in stool frequency, pain associated with a change in stool form 6. Have, on a weekly basis, stool consistency with more than 25% of loose stools and less than 25% of hard stools in the preceding month 7. Have a GIQLI score =125 8. Have an IBS-SSS score =75 (mild IBS) and <300 (moderate IBS) 9. Are capable of understanding and adhering to the protocol requirements 10. Are not currently taking and have not taken any medication throughout the study period, except for medications that inhibit intestinal function. When necessary, their use will be recorded as salvage treatment
Exclusion criteria
Exclusion criteria: 1. Are aged 70 years 2. Are pregnant, suspected to be pregnant, or planning to become pregnant 3. Are breastfeeding 4. Are dependent or not self-sufficient 5. Show unwillingness to collaborate 6. Have difficulties in attending the study site within the required time frames 7. Are deemed ineligible by the principal investigator due to the presence of other conditions considered incompatible with enrollment and requiring pharmacological treatments 8. Have acquired immunodeficiency due to HIV 9. Have known allergies to the ingredients of the experimental products (active or placebo) 10. Have a GIQLI score >125 11. Have an IBS-SSS score <75 (absence of IBS) 12. Have an IBS-SSS score =300 (severe IBS) 13. Experience abdominal pain less than once a week 14. Have organic intestinal diseases 15. Have undergone gastrointestinal surgery 16. Have Parkinson's disease or Alzheimer's disease 17. Use opioid medications or other drugs with a significant impact on intestinal function (e.g., antidepressants, aluminum-containing antacids) 18. Abuse alcohol, drugs, caffeine, or theine 19. Are currently taking antibiotics or have taken antibiotics in the last four weeks, or in the past 6 months depending on the intensity and duration of the antibiotic treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Gastrointestinal symptom-related quality of life assessed using the Gastrointestinal Quality of Life Index (GIQLI) at baseline (t0), day 28 (t1), day 56 (t2), day 84 (t3), and 28 days post-treatment (follow-up - tf) 2. IBS-related symptoms assessed using the IBS-Severity Scoring System (IBS-SSS) at baseline (t0), day 28 (t1), day 56 (t2), day 84 (t3), and 28 days post-treatment (follow-up - tf) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall quality of life assessed using Short Form-12 (SF-12) at baseline (t0), day 28 (t1), day 56 (t2), day 84 (t3), and 28 days post-treatment (follow-up - tf) 2. Stool consistency assessed using the Bristol Stool Form Scale (BSFS) at baseline (t0), day 28 (t1), day 56 (t2), day 84 (t3), and 28 days post-treatment (follow-up - tf) 3. Number of bowel movements per week (Bowel Movements - BM), reported by the subject at each study visit (average BM/week for the previous 4 weeks) and recorded in the daily bowel function diary throughout the study period at baseline (t0), day 28 (t1), day 56 (t2), day 84 (t3), and 28 days post-treatment (follow-up - tf) 4. The frequency and severity of Functional Gastrointestinal Disorders (FGIDs) evaluated using a 5-point Likert scale (0 no discomfort - 5 maximum discomfort), included in the daily bowel function diary completed for the entire duration of the study 5. The frequency of "salvage treatment" use, including motility-inhibiting medications, recorded through entries in the daily bowel function diary completed for the entire duration of the study 6. Intestinal inflammation assessed through the analysis of fecal inflammatory markers calprotectin and zonulin in a cohort of 30, with 15 from the treatment group and 15 from the placebo group, at baseline (t0), day 84 (t3) 7. Relative abundance of microbial species present in the treatment (Lactobacillus reuteri LR92, Lactobacillus acidophilus LA1, Bifidobacterium breve Bbr8) assessed to evaluate the colonization ability of the treatment under investigation. The investigation will be conducted on fecal samples. This analysis will be performed on a cohort of 30 subjects, with 15 from the treatment group and 15 from the placebo group at baseline (t0), day 84 (t3), 28 days post-treatment (follow-up – tf) | — |
Countries
Italy
Contacts
Public ContactAlessandra Baldi
Outcome results
None listed