Clinical trial NCT01969214: Safety and Efficacy of IQP-MM-101 in Reducing Symptoms of Diarrhoea
Official title: Open Label Study to Assess the Safety and Efficacy of IQP-MM-101 in Reducing Symptoms of Diarrhoea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diarrhoea
Lead sponsor: InQpharm Group
Sponsor class: INDUSTRY
First posted: 2013-10-25
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The clinical study was intended to evaluate the safety and the potential reduction of diarrhoea recovery time post 1st intake of IQP-MM-101 in an open label, single arm, multicentre study over a 72 hours period. There were 2 clinic visits: the screening visit and final visit.

At baseline visit (visit 1), written informed consents were collected. Each patients were given a diary and the following data were collected: demographics, vital signs, physical examination results, use of concomitant medication, previous medical history, and case history of the acute diarrhoea episode including date of first watery stool, number of stools over the past 24 hours, and presence of other associated symptoms over the past 24 hours (nausea, vomiting, abdominal pain).

Subjects recorded the following data in the diary: date and hour of bowel movement, stool consistency (Bristol stool scale) presence of symptoms such as nausea, vomiting, abdominal pain and study IP consumption (number, date, and time of tablets taken) and time of vomiting (if any) each day during the treatment period. Additionally, subjects recorded the time absent from work and a subjective evaluation of their "energy for everyday life".

Visit 2 took place after 72 hours treatment period. Following data was collected:

* Vital signs, physical examination
* Adverse events
* Use of concomitant medication
* Compliance (returned IP and diary)
* Global evaluation of efficacy and safety by subjects and investigators

During the 72-hour treatment period, all subjects were instructed to consumed IQP-MM-101 according to the following dosage: one (1) tablet, three (3) times a day dissolved in at least 125mL (half a glass) of water.

Eligibility criteria: 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

Primary outcomes:
measure: Time (in Hours) Between the 1st Intake of IQP-MM-101 and First Formed or Hard Stool (Type 6 to 1) Followed by a Non Watery Stool (Type 6 to 1)
timeFrame: 96 hours
Secondary outcomes:
measure: Time (Hours) From the First Intake to the Last Watery Stool
timeFrame: 96 hours
measure: Number of Daily Defecation
timeFrame: 96 hours
measure: Number of Watery Stools
timeFrame: 96 hours
measure: Stool Frequency
timeFrame: 96 hours
measure: Percentage of Patients Having Recovered Within a Certain Time Period (Defined as Having Achieved the Primary Efficacy Endpoint)
timeFrame: 72 hours
measure: Abdominal Pain
timeFrame: 96 hours
measure: Time Off From Work
timeFrame: 1 week
measure: Evaluation of Subjects' Energy Level
timeFrame: 96 hours
measure: Global Evaluation of Safety and Efficacy by Subjects and Investigators
timeFrame: 96 hours
measure: Occurrence of Adverse Events (AEs)
timeFrame: 96 hours
measure: Associated Symptoms Such as Vomiting
timeFrame: 96 hours
measure: Stool Consistency
timeFrame: 96 hours
measure: Severity of Nausea
timeFrame: 96 hours
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: analyze & realize GmbH
Study officials:
affiliation: analyze & realize GmbH
name: Ralf Uebelhack
role: PRINCIPAL_INVESTIGATOR
References: