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

ISRCTN	ISRCTN90311828
DOI	https://doi.org/10.1186/ISRCTN90311828
Protocol serial number	NC_TAS_011012
Sponsor	Novintethical Pharma
Funder	Novitethical Pharma SA

Submission date: 02/06/2015
Registration date: 11/06/2015
Last edited: 13/07/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Plain English summary under review

Contact information

Mr Manolache Mihai
Scientific

222nd Calea Plevnei 3rd Floor
Bucharest
060016
Romania

Phone	+40 (0)731834503
Email	mihai.manolache@cebis-int.com

Study information

Primary study design	Interventional
Study design	Multicenter open-label parallel-group active treatment controlled randomized clinical study
Secondary study design	Randomised parallel trial
Study type	Participant information sheet
Scientific title	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
Study objectives	1. Is Tasectan Plus safer than Diosmectite and S. boulardii? 2. Is Tasectan Plus more efficient than Diosmectite and S. boulardii?
Ethics approval(s)	Med trial research, 01/11/2013, ref: 31
Health condition(s) or problem(s) studied	Diarrhea
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.
Intervention type	Device
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure(s)	Frequency of AE/SAE in each arm
Key secondary outcome measure(s)	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.
Completion date	01/06/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	150
Key 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
Key exclusion criteria	1. Allergy to one of the product ingredients 2. Pregnant women or breastfeeding 3. Recent surgery 4. Serious and/or systemic diseases
Date of first enrolment	25/11/2013
Date of final enrolment	15/04/2014

Locations

Countries of recruitment

Romania

Study participating centres

University of Medicine & Pharmacy Targu-Mures

540139
Romania

Dr. Pleasea Condratovici Catalin Private Practice

Galati
805200
Romania

Dr. Nedelcu Steluta Private Practice

Galati
810289

Dr. Rosoga Natalia Private Practice

Targu Jiu
210166
Romania

Dr. Gavanescu Mihaela Private Practice

Bucharest
031753

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	30/10/2015		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

02/11/2015: Publication reference added.