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

Safety and efficacy and rapidity of action of Tasectan Plus vs Diosmectite and vs S. Bouliardii in the treatment of acute diarrhea: multicenter, randomized, open label, parallel group, controlled clinical study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN90311828

Enrollment

150

Registered

2015-06-11

Start date

2013-11-25

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diarrhea Digestive System

Interventions

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. Th

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Frequency of AE/SAE in each arm	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Romania

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026