Safety and Efficacy of IQP-MM-101 in Reducing Symptoms of Diarrhoea

Study Overview
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Brief Summary
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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
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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.

Official Title
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Open Label Study to Assess the Safety and Efficacy of IQP-MM-101 in Reducing Symptoms of Diarrhoea

Conditions
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Diarrhoea

Intervention / Treatment
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* Device: IQP-MM-101


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IQP-MM-101<br>Dissolve the effervescent tablets in half a glass of water,to be taken orally 1 tablet, 3 times a day | Device: IQP-MM-101<br>* Dissolve the effervescent tablets in half a glass of water, to be taken orally 1 tablet, 3 times a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | In essence the definition of recovery would be two consecutive non-watery stool (type 6 to 1) when stool before 1st intake of IQP-MM-101 is primarily watery (type 7). | 96 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time (Hours) From the First Intake to the Last Watery Stool | The last watery stool was assumed as the first-non watery stool | 96 hours | 
| Number of Daily Defecation |  | 96 hours | 
| Number of Watery Stools |  | 96 hours | 
| Stool Frequency | The mean number of daily defecation. | 96 hours | 
| Percentage of Patients Having Recovered Within a Certain Time Period (Defined as Having Achieved the Primary Efficacy Endpoint) |  | 72 hours | 
| Abdominal Pain | Subjects feeling of abdominal pain was measured on visual analog scale of 0 - 100mm (no pain to severe pain). | 96 hours | 
| Time Off From Work |  | 1 week | 
| Evaluation of Subjects' Energy Level | The subjective measure of subjects' daily energy level was determined by severity of weakness felt by the subjects, measured on visual analog scale (0-100mm, 100mm being most severe weakness). | 96 hours | 
| Global Evaluation of Safety and Efficacy by Subjects and Investigators | The subjects and investigators will evaluate independently the safety of the investigational device (global scaled evaluation with very good, good, moderate and poor). | 96 hours | 
| Occurrence of Adverse Events (AEs) |  | 96 hours | 
| Associated Symptoms Such as Vomiting |  | 96 hours | 
| Stool Consistency | Stool consistency is measured by Bristol Stool Form Scale 1-7. Separate hard lumps, like nuts (hard to pass) Sausage-shaped, but lumpy Like a sausage but with cracks on its surface Like a sausage or snake, smooth and soft Soft blobs with clear cut edges (easy to pass) Fluffy pieces with ragged edges, a mushy stool Watery, no solid pieces, entirely liquid Stool consistency is the mean of the scale measured each day. | 96 hours | 
| Severity of Nausea | Subjects feeling of nausea was measured on visual analog scale of 0 - 100mm (no nausea to severe nausea). | 96 hours |