Diarrhoea
Conditions
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.
Interventions
DEVICEIQP-MM-101
Dissolve the effervescent tablets in half a glass of water, to be taken orally 1 tablet, 3 times a day
Sponsors
InQpharm Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 96 hours | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Daily Defecation | 96 hours | — |
| Number of Watery Stools | 96 hours | — |
| Stool Frequency | 96 hours | The mean number of daily defecation. |
| Percentage of Patients Having Recovered Within a Certain Time Period (Defined as Having Achieved the Primary Efficacy Endpoint) | 72 hours | — |
| Abdominal Pain | 96 hours | Subjects feeling of abdominal pain was measured on visual analog scale of 0 - 100mm (no pain to severe pain). |
| Time Off From Work | 1 week | — |
| Time (Hours) From the First Intake to the Last Watery Stool | 96 hours | The last watery stool was assumed as the first-non watery stool |
| Global Evaluation of Safety and Efficacy by Subjects and Investigators | 96 hours | The subjects and investigators will evaluate independently the safety of the investigational device (global scaled evaluation with very good, good, moderate and poor). |
| Occurrence of Adverse Events (AEs) | 96 hours | — |
| Associated Symptoms Such as Vomiting | 96 hours | — |
| Stool Consistency | 96 hours | Stool consistency is measured by Bristol Stool Form Scale 1-7. 1. Separate hard lumps, like nuts (hard to pass) 2. Sausage-shaped, but lumpy 3. Like a sausage but with cracks on its surface 4. Like a sausage or snake, smooth and soft 5. Soft blobs with clear cut edges (easy to pass) 6. Fluffy pieces with ragged edges, a mushy stool 7. Watery, no solid pieces, entirely liquid Stool consistency is the mean of the scale measured each day. |
| Severity of Nausea | 96 hours | Subjects feeling of nausea was measured on visual analog scale of 0 - 100mm (no nausea to severe nausea). |
| Evaluation of Subjects' Energy Level | 96 hours | 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). |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IQP-MM-101 Dissolve the effervescent tablets in half a glass of water,to be taken orally
1 tablet, 3 times a day
IQP-MM-101: Dissolve the effervescent tablets in half a glass of water, to be taken orally
1 tablet, 3 times a day | 86 |
| Total | 86 |
Baseline characteristics
| Characteristic | IQP-MM-101 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 86 Participants |
| Age, Continuous | 35.1 years STANDARD_DEVIATION 11.4 |
| Region of Enrollment Germany | 86 participants |
| Sex: Female, Male Female | 40 Participants |
| Sex: Female, Male Male | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 99 |
| serious Total, serious adverse events | 0 / 99 |
Outcome results
Primary
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).
Time frame: 96 hours
Population: 6 participants recovered before first intake of IQP-MM-101, while in another, there was no defecation reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IQP-MM-101 | 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) | 21.30 hours | Standard Deviation 16.02 |
Secondary
Abdominal Pain
Subjects feeling of abdominal pain was measured on visual analog scale of 0 - 100mm (no pain to severe pain).
Time frame: 96 hours
Population: All 86 subjects recorded abdominal pain on day 1 and day 2. 85 subjects recorded abdominal pain on day 3 and 67 subjects recorded abdominal pain on day 4.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IQP-MM-101 | Abdominal Pain | Severity of abdominal pain Day 1 | 56.2 mm | Standard Deviation 23.6 |
| IQP-MM-101 | Abdominal Pain | Severity of abdominal pain Day 2 | 35.3 mm | Standard Deviation 20.8 |
| IQP-MM-101 | Abdominal Pain | Severity of abdominal pain Day 3 | 18.7 mm | Standard Deviation 16.7 |
| IQP-MM-101 | Abdominal Pain | Severity of abdominal pain Day 4 | 11.1 mm | Standard Deviation 14.3 |
Secondary
Associated Symptoms Such as Vomiting
Time frame: 96 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IQP-MM-101 | Associated Symptoms Such as Vomiting | Affected subjects at day 1 | 23.3 Percentage of subjects |
| IQP-MM-101 | Associated Symptoms Such as Vomiting | Affected subjects at day 2 | 3.5 Percentage of subjects |
| IQP-MM-101 | Associated Symptoms Such as Vomiting | Affected subjects at day 3 | 3.5 Percentage of subjects |
| IQP-MM-101 | Associated Symptoms Such as Vomiting | Affected subjects at day 4 | 3.5 Percentage of subjects |
Secondary
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).
Time frame: 96 hours
Population: Only 85 subjects responded to Day 3 and only 67 subjects responded to Day 4 assessment of weakness
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IQP-MM-101 | Evaluation of Subjects' Energy Level | Severity of Weakness Day 1 | 67.5 mm | Standard Deviation 21.5 |
| IQP-MM-101 | Evaluation of Subjects' Energy Level | Severity of Weakness Day 2 | 45.7 mm | Standard Deviation 24.7 |
| IQP-MM-101 | Evaluation of Subjects' Energy Level | Severity of Weakness Day 3 | 29.5 mm | Standard Deviation 24.6 |
| IQP-MM-101 | Evaluation of Subjects' Energy Level | Severity of Weakness Day 4 | 16.8 mm | Standard Deviation 19.7 |
Secondary
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).
Time frame: 96 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IQP-MM-101 | Global Evaluation of Safety and Efficacy by Subjects and Investigators | Efficacy by Investigator - Very Good | 21 participants |
| IQP-MM-101 | Global Evaluation of Safety and Efficacy by Subjects and Investigators | Efficacy by Investigator - Good | 61 participants |
| IQP-MM-101 | Global Evaluation of Safety and Efficacy by Subjects and Investigators | Efficacy by Investigator - Moderate | 2 participants |
| IQP-MM-101 | Global Evaluation of Safety and Efficacy by Subjects and Investigators | Efficacy by Investigator - Poor | 2 participants |
| IQP-MM-101 | Global Evaluation of Safety and Efficacy by Subjects and Investigators | Efficacy by Subjects - Very Good | 28 participants |
| IQP-MM-101 | Global Evaluation of Safety and Efficacy by Subjects and Investigators | Efficacy by Subjects - Good | 54 participants |
| IQP-MM-101 | Global Evaluation of Safety and Efficacy by Subjects and Investigators | Efficacy by Subjects - Moderate | 2 participants |
| IQP-MM-101 | Global Evaluation of Safety and Efficacy by Subjects and Investigators | Efficacy by Subjects - Poor | 2 participants |
| IQP-MM-101 | Global Evaluation of Safety and Efficacy by Subjects and Investigators | Safety by Investigator - Very Good | 51 participants |
| IQP-MM-101 | Global Evaluation of Safety and Efficacy by Subjects and Investigators | Safety by Investigator - Good | 34 participants |
| IQP-MM-101 | Global Evaluation of Safety and Efficacy by Subjects and Investigators | Safety by Investigator - Moderate | 1 participants |
| IQP-MM-101 | Global Evaluation of Safety and Efficacy by Subjects and Investigators | Safety by Investigator - Poor | 0 participants |
| IQP-MM-101 | Global Evaluation of Safety and Efficacy by Subjects and Investigators | Safety by Subjects - Very Good | 50 participants |
| IQP-MM-101 | Global Evaluation of Safety and Efficacy by Subjects and Investigators | Safety by Subjects - Good | 36 participants |
| IQP-MM-101 | Global Evaluation of Safety and Efficacy by Subjects and Investigators | Safety by Subjects - Moderate | 0 participants |
| IQP-MM-101 | Global Evaluation of Safety and Efficacy by Subjects and Investigators | Safety by Subjects - Poor | 0 participants |
Secondary
Number of Daily Defecation
Time frame: 96 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IQP-MM-101 | Number of Daily Defecation | Day 1 | 387 stools |
| IQP-MM-101 | Number of Daily Defecation | Day 2 | 278 stools |
| IQP-MM-101 | Number of Daily Defecation | Day 3 | 200 stools |
| IQP-MM-101 | Number of Daily Defecation | Day 4 | 82 stools |
Secondary
Number of Watery Stools
Time frame: 96 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IQP-MM-101 | Number of Watery Stools | Day 4 | 10 stools |
| IQP-MM-101 | Number of Watery Stools | Day 1 | 292 stools |
| IQP-MM-101 | Number of Watery Stools | Day 2 | 72 stools |
| IQP-MM-101 | Number of Watery Stools | Day 3 | 20 stools |
Secondary
Occurrence of Adverse Events (AEs)
Time frame: 96 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IQP-MM-101 | Occurrence of Adverse Events (AEs) | 7 Adverse Events |
Secondary
Percentage of Patients Having Recovered Within a Certain Time Period (Defined as Having Achieved the Primary Efficacy Endpoint)
Time frame: 72 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IQP-MM-101 | Percentage of Patients Having Recovered Within a Certain Time Period (Defined as Having Achieved the Primary Efficacy Endpoint) | Recovery time: Up to 24 hours | 25.3 Percentage of subjects |
| IQP-MM-101 | Percentage of Patients Having Recovered Within a Certain Time Period (Defined as Having Achieved the Primary Efficacy Endpoint) | Recovery time: More than 24 up to 30 hours | 21.5 Percentage of subjects |
| IQP-MM-101 | Percentage of Patients Having Recovered Within a Certain Time Period (Defined as Having Achieved the Primary Efficacy Endpoint) | Recovery time: More than 30 up to 36 hours | 8.9 Percentage of subjects |
| IQP-MM-101 | Percentage of Patients Having Recovered Within a Certain Time Period (Defined as Having Achieved the Primary Efficacy Endpoint) | Recovery time: More than 36 up to 42 hours | 7.6 Percentage of subjects |
| IQP-MM-101 | Percentage of Patients Having Recovered Within a Certain Time Period (Defined as Having Achieved the Primary Efficacy Endpoint) | Recovery time: More than 42 up to 48 hours | 16.5 Percentage of subjects |
| IQP-MM-101 | Percentage of Patients Having Recovered Within a Certain Time Period (Defined as Having Achieved the Primary Efficacy Endpoint) | Recovery time: More than 48 up to 60 hours | 10.1 Percentage of subjects |
| IQP-MM-101 | Percentage of Patients Having Recovered Within a Certain Time Period (Defined as Having Achieved the Primary Efficacy Endpoint) | Recovery time: More than 60 up to 72 hours | 8.9 Percentage of subjects |
| IQP-MM-101 | Percentage of Patients Having Recovered Within a Certain Time Period (Defined as Having Achieved the Primary Efficacy Endpoint) | Recovery time: More than 72 hours | 1.3 Percentage of subjects |
Secondary
Severity of Nausea
Subjects feeling of nausea was measured on visual analog scale of 0 - 100mm (no nausea to severe nausea).
Time frame: 96 hours
Population: All 86 subjects recorded nausea on day 1 and day 2. 85 subjects recorded nausea on day 3 and 67 subjects recorded nausea on day 4.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IQP-MM-101 | Severity of Nausea | Severity of nausea Day 1 | 44.8 mm | Standard Deviation 29.5 |
| IQP-MM-101 | Severity of Nausea | Severity of nausea Day 2 | 28.1 mm | Standard Deviation 23.4 |
| IQP-MM-101 | Severity of Nausea | Severity of nausea Day 3 | 12.9 mm | Standard Deviation 16 |
| IQP-MM-101 | Severity of Nausea | Severity of nausea Day 4 | 8.3 mm | Standard Deviation 13.7 |
Secondary
Stool Consistency
Stool consistency is measured by Bristol Stool Form Scale 1-7. 1. Separate hard lumps, like nuts (hard to pass) 2. Sausage-shaped, but lumpy 3. Like a sausage but with cracks on its surface 4. Like a sausage or snake, smooth and soft 5. Soft blobs with clear cut edges (easy to pass) 6. Fluffy pieces with ragged edges, a mushy stool 7. Watery, no solid pieces, entirely liquid Stool consistency is the mean of the scale measured each day.
Time frame: 96 hours
Population: 387, 278, 200 and 82 stool samples were obtained on day 1, 2, 3 and 4 respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IQP-MM-101 | Stool Consistency | Type of Stool Day 1 | 6.66 score on a scale | Standard Deviation 0.84 |
| IQP-MM-101 | Stool Consistency | Type of Stool Day 2 | 5.83 score on a scale | Standard Deviation 1.33 |
| IQP-MM-101 | Stool Consistency | Type of Stool Day 3 | 4.18 score on a scale | Standard Deviation 1.5 |
| IQP-MM-101 | Stool Consistency | Type of Stool Day 4 | 3.32 score on a scale | Standard Deviation 1.25 |
Secondary
Stool Frequency
The mean number of daily defecation.
Time frame: 96 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IQP-MM-101 | Stool Frequency | Stool Frequency Day 1 | 4.50 No. of daily defecation | Standard Deviation 2.57 |
| IQP-MM-101 | Stool Frequency | Stool Frequency Day 2 | 3.23 No. of daily defecation | Standard Deviation 1.9 |
| IQP-MM-101 | Stool Frequency | Stool Frequency Day 3 | 2.33 No. of daily defecation | Standard Deviation 1.58 |
| IQP-MM-101 | Stool Frequency | Stool Frequency Day 4 | 0.95 No. of daily defecation | Standard Deviation 1.03 |
Secondary
Time (Hours) From the First Intake to the Last Watery Stool
The last watery stool was assumed as the first-non watery stool
Time frame: 96 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IQP-MM-101 | Time (Hours) From the First Intake to the Last Watery Stool | 18.17 Hours | Standard Deviation 15.85 |
Secondary
Time Off From Work
Time frame: 1 week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IQP-MM-101 | Time Off From Work | More than 6 days of absent | 8.1 Percentage of subjects |
| IQP-MM-101 | Time Off From Work | 2 days of absent | 11.6 Percentage of subjects |
| IQP-MM-101 | Time Off From Work | 3 days of absent | 7.0 Percentage of subjects |
| IQP-MM-101 | Time Off From Work | 4 days of absent | 12.8 Percentage of subjects |
| IQP-MM-101 | Time Off From Work | 5 days of absent | 24.4 Percentage of subjects |
| IQP-MM-101 | Time Off From Work | 0 day of absent | 31.4 Percentage of subjects |
| IQP-MM-101 | Time Off From Work | 1 day of absent | 4.7 Percentage of subjects |