Diarrhoea | Safety and Efficacy of IQP-MM-101 in Reducing Symptoms of Diarrhoea
Diarrhoea research study
What is the primary objective of this study?
Diosmectite in IQP-MM-101 has been used for diarrhoea control. Backed by data from several studies demonstrating their efficacy, the investigators are conducting this study to look into the efficacy and safety of IQP-MM-101 in diarrhoea control.
Who is eligible to participate?
Inclusion Criteria: - Age 18 to 65 years - Good general health - Acute diarrhoea episode defined as at least three watery stools per 24 hours over a period of 48 hours or less - Acute diarrhoea of presumed infectious origin - Patients with usually normal bowel movements (defecations) before onset of diarrhoea, that is, at least three normal stools per week and three or less normal stools per day - Negative pregnancy test (ß HCG-test) for women with child bearing potential - Written informed consent is a prerequisite for subject enrollment Exclusion Criteria: - Known sensitivity to the ingredients of the device - Fever >38,5◦C - Blood or pus in stools - Dehydration requiring intravenous rehydration - History of chronic diarrhoea (three or more loose or watery stools per day for at least 12 weeks, consecutive or not, in the preceding 12 months) - Use of antidiarrhoeal agents over the month prior to baseline - Diarrhoea possibly induced by antibiotics, laxative agents, thyroid hormones, or colchicine - Irritable bowel syndrome - Any other acute or chronic disease that could interfere with the evaluation of study device - Females who are pregnant or lactating - Subjects who have participated in another clinical trial in the 30 days before treatment period - Inability to comply - Presence of other factor(s) that, in the investigator's judgement, should preclude subject participation
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Device:IQP-MM-101Dissolve the effervescent tablets in half a glass of water, to be taken orally 1 tablet, 3 times a day
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
IQP-MM-101Dissolve the effervescent tablets in half a glass of water,to be taken orally 1 tablet, 3 times a day
Start Date: October 2013
Completed Date: April 2014
Phase: Phase 3
Primary Outcome: Time (in hours) between the 1st intake of IQP-MM-101 and first formed or hard stool followed by a non watery stool
Secondary Outcome: Time (hours) from the first intake to the last watery stool
Study sponsors, principal investigator, and references
Lead Sponsor: InQpharm Group