Safety and efficacy and rapidity of action of Tasectan Plus vs Diosmectite and vs S. Bouliardii in the treatment of acute diarrhea

Completed

Conditions: Diarrhea
Digestive System

Registration Number: ISRCTN90311828

Lead Sponsor: ovintethical Pharma

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 150

Inclusion Criteria

1. Informed consent
2. Subjects of both sex aged over 18
3. Presence of diarrhea defined as occurrence of > 3 stools per day graded 6 or 7 on the Bristol
scale

Exclusion Criteria

1. Allergy to one of the product ingredients
2. Pregnant women or breastfeeding
3. Recent surgery
4. Serious and/or systemic diseases

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of AE/SAE in each arm

Secondary Outcome Measures

Name	Time	Method
Efficacy will be evaluated as following:<br>The patients will assume the first treatment dose at time of recruitment, i.e. already at the doctor's office and will be trained for the self-administration of an ad-hoc symptoms questionnaire to record their stools and symptoms at 1, 3, 6, 12, 24 and 48 hours following the first study dose.<br>The symptoms recorded will be objective (stools, vomiting and fever) and subjective (nausea,<br>abdominal pain, and bloating). The stools grading will be according to the Bristol scale, presence of mucus and blood will be also recorded. The intensity of subjective symptoms will be graded by a VAS.