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

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2015
INTERVENTION: Tasectan Plus vs Diosmectite vs S. boulardii Patients fulfilling the inclusion criteria will be recruited by family doctors during their normal daily practice and randomised for a 2 day treatment. The study duration is expected to be at least 3 days or maximum 10 days. CONDITION: Diarrhea ; Digestive System PRIMARY OUTCOME: Frequency of AE/SAE in each arm SECONDARY OUTCOME: Efficacy will be evaluated as following:; 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.; The symptoms recorded will be objective (stools, vomiting and fever) and subjective (nausea,; 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. 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
Epistemonikos ID: 4fd8832c5da4c24c5220f2ef24f69302c423d934
First added on: Aug 23, 2024