Subjects with irritable bowel syndrome (IBS), specifically those with predominant constipation (IBS-C) and diarrhea (IBS-D) Digestive System
Conditions
Interventions
The subjects recruited in the present clinical study have been randomized into the following experimental groups:
GROUP 1:
Subjects took two capsules of the dietary supplement, a mixture of tannins fr
Sponsors
Istituto Nazionale Biostrutture e Biosistemi
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age ranging from 18 to 70 years 2. Capable of understanding and signing the informed consent 3. Negative HIV test 4. Negative pregnancy test 5. Symptoms of IBS for at least three months (onset at least six months prior), including recurrent abdominal pain occurring at least once a week, associated with two or more of the following criteria: symptoms related to bowel movements and/or changes in the frequency of bowel movements and/or changes in stool consistency (Rome IV diagnostic criteria) 6. IBS forms considered were either with a predominance of constipation (stool consistency: more than 25% hard stools and less than 25% soft stools) or with a predominance of diarrhea (stool consistency: more than 25% soft stools and less than 25% hard stools) 7. Able to understand and adhere to the protocol requirements
Exclusion criteria
Exclusion criteria: 1. Age less than 18 or greater than 70 years 2. In a state of pregnancy or breastfeeding 3. Subjects with abdominal pain occurring less than once a week 4. Organic intestinal diseases 5. Gastrointestinal surgery 6. Parkinson's disease or Alzheimer's disease 7. Acquired immunodeficiency due to HIV 8. Opioid medications or other drugs that significantly impact intestinal function (e.g., antidepressants, aluminium-containing antacids) 9. Abuse alcohol, drugs, caffeine, or theine 10. Currently taking antibiotics or who have taken antibiotics in the past four weeks, or within the last six months, depending on the intensity and duration of the antibiotic treatment 11. Cognitive disorders that may hinder their ability to respond to questionnaires 12. Unwilling to collaborate 13. Difficulty attending the designated facility within the required times 14. Deemed ineligible by the principal investigator due to other conditions considered incompatible with enrollment 15. A known allergy to the ingredients in the experimental products (active or placebo)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The improvement of perceived gastrointestinal symptoms measured using the self-assessment questionnaire for gastrointestinal symptom severity characteristic of IBS IBS-Severity Scoring System (IBS-SSS) at baseline (t0) and day 56 (t1) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The improvement of individual quality of life measured using the validated questionnaire for self-assessment of quality of life in individuals with IBS, the IBS-Quality of Life (IBS-QoL) and the validated questionnaire for self-assessment of quality of life associated with gastrointestinal symptoms, the Gastrointestinal Quality of Life Index (GIQLI), at baseline (t0) and day 56 (t1) 2. The improvement of stool consistency measured using the validated tool that assesses stool consistency across a spectrum of seven types Bristol Stool Form Scale- BSFS at baseline (t0) and day 56 (t1) 3. The frequency of bowel movements measured using the number of bowel movements per week (Bowel Movements/Week- BM/WK), reported by the subject during visits (average of BM per week over the preceding 4 weeks) and recorded, throughout the study period in the Bowel Function Diary at baseline (t0) and day 56 (t1) and in the bowel function diary 4. The frequency and intensity of symptoms characteristic of IBS measured using a 5-point Likert scale (0 no discomfort – 5 maximum discomfort), included in the Daily Bowel Function Diary completed daily for the entire duration of the study 5. The reduction in the frequency of the use of salvage treatments measured using data that was recorded through the completion of the Bowel Function Diary daily for the entire duration of the study | — |
Countries
Italy
Contacts
Public ContactAlessandra Baldi
Outcome results
None listed