Chronic diarrhoea Digestive System Functional diarrhoea
Conditions
Interventions
Visit 1 – Baseline visit
Visit 2 (Day 8) – Randomization visit
Visit 3 (Day 36) – End of treatment/end of study
Patients fulfilling the inclusion crite
Sponsors
Noventure S.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Chronic diarrhoea defined as a morbid process of at least 4 weeks of duration and a change in stool consistency to loose or liquid form (types 5-7, according to the Bristol Stool Chart) and/or an increase in the frequency of evacuations (=3 in 24 h) 2. Patients diagnosed with irritable bowel syndrome or functional diarrhoea (according to the Rome IV criteria) or biliary acid malabsorption 3. Patients will be included if they record, during the week before randomization, an average score for stool consistency of =5.5 or a score of =5 on the Bristol Stool Chart for at least 5 days and an average score of =3.5 or a score of =3 for at least 5 days in the number of bowel movements 4. Participants will be tested at baseline for functional intestinal dysbiosis (Aliment Pharmacol Ther 2012;35(7):828-38), as demonstrated by real-time PCR analysis of faecal samples 5. Ability to sign the informed consent form
Exclusion criteria
Exclusion criteria: 1. Use of antibiotics, gelatin tannate, diosmectite, probiotics, racecadotril, zinc, opioids, or any other drugs or medical devices know to alter gastrointestinal motility or secretion within 4 weeks prior to enrolment 2. Chronic diarrhoea caused by cystic fibrosis, coeliac disease, food allergy, diabetes 3. Chronic diarrhoea caused by lactose, fructose, or sorbitol intolerance 4. Immunodeficiencies 5. Abnormal thyroid function, a history of alcohol abuse or binge drinking, pancreatitis, sphincter of Oddi dysfunction, cholecystitis within the past 6 months, or known allergy to any of the components of the product or placebo 6. Pregnant or breastfeeding women 7. Patients receiving antidepressant medications will be eligible to participate in the study, provided that dosing has been stable for 12 weeks or longer before enrollment 8. If needed, discontinuation or modification of the treatment may be considered at the discretion of the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Pain relief assessed using an 11-point scale from 0-10 in the subject diary on each day of the treatment period 2. Major symptoms of chronic diarrhoea (abdominal pain and distension) assessed on a 7-point Likert scale in the subject diary on each week of the treatment period 3. Proportion of subjects who tested negative for dysbiosis using PCR at baseline and day 36 4. Relief of symptoms assessed through the subject diary on each week of the treatment period. Additionally, the timing for the beginning of the clinical response will be also evaluated. 5. Stool consistency assessed on the Bristol scale through the subject diary on each week of the treatment period 6. BMI, abdominal girth and weight measured using physician evaluation at baseline and day 36 7. Bowel movement frequency assessed using an 11-point scale from 0-10 in the subject diary on each day of the treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety assessed by: 1. No. of subjects that discontinued treatment due to adverse events at day 36 2. No. of subjects that experienced an adverse event and severity at day 36 3. Proportion of subjects who presented no improvement in clinical condition at day 36 | — |
Countries
Bulgaria, Romania
Outcome results
None listed