Trial Outcomes & Findings for Safety and Efficacy of IQP-MM-101 in Reducing Symptoms of Diarrhoea (NCT NCT01969214)

NCT ID: NCT01969214

Last Updated: 2020-03-04

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 101 participants
• Primary outcome timeframe: 96 hours
• Results posted on: 2020-03-04

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	101
Overall Study COMPLETED	86
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	IQP-MM-101 n=86 Participants 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
Age, Continuous	35.1 years STANDARD_DEVIATION 11.4 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	86 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants
Sex: Female, Male Male	46 Participants n=5 Participants
Region of Enrollment Germany	86 participants n=5 Participants

PRIMARY outcome

Timeframe: 96 hours

Population: 6 participants recovered before first intake of IQP-MM-101, while in another, there was no defecation reported.

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).

Outcome measures

Measure	IQP-MM-101 n=79 Participants 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
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 outcome

Timeframe: 96 hours

The last watery stool was assumed as the first-non watery stool

Outcome measures

Measure	IQP-MM-101 n=79 Participants 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
Time (Hours) From the First Intake to the Last Watery Stool	18.17 Hours Standard Deviation 15.85

SECONDARY outcome

Timeframe: 96 hours

Outcome measures

Measure	IQP-MM-101 n=86 Participants 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
Number of Daily Defecation Day 1	387 stools
Number of Daily Defecation Day 2	278 stools
Number of Daily Defecation Day 3	200 stools
Number of Daily Defecation Day 4	82 stools

SECONDARY outcome

Timeframe: 96 hours

Outcome measures

Measure	IQP-MM-101 n=86 Participants 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
Number of Watery Stools Day 3	20 stools
Number of Watery Stools Day 4	10 stools
Number of Watery Stools Day 1	292 stools
Number of Watery Stools Day 2	72 stools

SECONDARY outcome

Timeframe: 96 hours

The mean number of daily defecation.

Outcome measures

Measure	IQP-MM-101 n=86 Participants 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
Stool Frequency Stool Frequency Day 1	4.50 No. of daily defecation Standard Deviation 2.57
Stool Frequency Stool Frequency Day 2	3.23 No. of daily defecation Standard Deviation 1.90
Stool Frequency Stool Frequency Day 3	2.33 No. of daily defecation Standard Deviation 1.58
Stool Frequency Stool Frequency Day 4	0.95 No. of daily defecation Standard Deviation 1.03

SECONDARY outcome

Timeframe: 72 hours

Outcome measures

Measure	IQP-MM-101 n=79 Participants 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
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
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
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
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
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
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
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
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 outcome

Timeframe: 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.

Subjects feeling of abdominal pain was measured on visual analog scale of 0 - 100mm (no pain to severe pain).

Outcome measures

Measure	IQP-MM-101 n=86 Participants 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
Abdominal Pain Severity of abdominal pain Day 1	56.2 mm Standard Deviation 23.6
Abdominal Pain Severity of abdominal pain Day 2	35.3 mm Standard Deviation 20.8
Abdominal Pain Severity of abdominal pain Day 3	18.7 mm Standard Deviation 16.7
Abdominal Pain Severity of abdominal pain Day 4	11.1 mm Standard Deviation 14.3

SECONDARY outcome

Timeframe: 1 week

Outcome measures

Measure	IQP-MM-101 n=86 Participants 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
Time Off From Work 1 day of absent	4.7 Percentage of subjects
Time Off From Work 2 days of absent	11.6 Percentage of subjects
Time Off From Work 3 days of absent	7.0 Percentage of subjects
Time Off From Work 4 days of absent	12.8 Percentage of subjects
Time Off From Work 5 days of absent	24.4 Percentage of subjects
Time Off From Work More than 6 days of absent	8.1 Percentage of subjects
Time Off From Work 0 day of absent	31.4 Percentage of subjects

SECONDARY outcome

Timeframe: 96 hours

Population: Only 85 subjects responded to Day 3 and only 67 subjects responded to Day 4 assessment of weakness

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).

Outcome measures

Measure	IQP-MM-101 n=86 Participants 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
Evaluation of Subjects' Energy Level Severity of Weakness Day 1	67.5 mm Standard Deviation 21.5
Evaluation of Subjects' Energy Level Severity of Weakness Day 2	45.7 mm Standard Deviation 24.7
Evaluation of Subjects' Energy Level Severity of Weakness Day 3	29.5 mm Standard Deviation 24.6
Evaluation of Subjects' Energy Level Severity of Weakness Day 4	16.8 mm Standard Deviation 19.7

SECONDARY outcome

Timeframe: 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").

Outcome measures

Measure	IQP-MM-101 n=86 Participants 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
Global Evaluation of Safety and Efficacy by Subjects and Investigators Efficacy by Investigator - Very Good	21 participants
Global Evaluation of Safety and Efficacy by Subjects and Investigators Efficacy by Investigator - Good	61 participants
Global Evaluation of Safety and Efficacy by Subjects and Investigators Efficacy by Investigator - Moderate	2 participants
Global Evaluation of Safety and Efficacy by Subjects and Investigators Efficacy by Investigator - Poor	2 participants
Global Evaluation of Safety and Efficacy by Subjects and Investigators Efficacy by Subjects - Very Good	28 participants
Global Evaluation of Safety and Efficacy by Subjects and Investigators Efficacy by Subjects - Good	54 participants
Global Evaluation of Safety and Efficacy by Subjects and Investigators Efficacy by Subjects - Moderate	2 participants
Global Evaluation of Safety and Efficacy by Subjects and Investigators Efficacy by Subjects - Poor	2 participants
Global Evaluation of Safety and Efficacy by Subjects and Investigators Safety by Investigator - Very Good	51 participants
Global Evaluation of Safety and Efficacy by Subjects and Investigators Safety by Investigator - Good	34 participants
Global Evaluation of Safety and Efficacy by Subjects and Investigators Safety by Investigator - Moderate	1 participants
Global Evaluation of Safety and Efficacy by Subjects and Investigators Safety by Investigator - Poor	0 participants
Global Evaluation of Safety and Efficacy by Subjects and Investigators Safety by Subjects - Very Good	50 participants
Global Evaluation of Safety and Efficacy by Subjects and Investigators Safety by Subjects - Good	36 participants
Global Evaluation of Safety and Efficacy by Subjects and Investigators Safety by Subjects - Moderate	0 participants
Global Evaluation of Safety and Efficacy by Subjects and Investigators Safety by Subjects - Poor	0 participants

SECONDARY outcome

Timeframe: 96 hours

Outcome measures

Measure	IQP-MM-101 n=99 Participants 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
Occurrence of Adverse Events (AEs)	7 Adverse Events

SECONDARY outcome

Timeframe: 96 hours

Outcome measures

Measure	IQP-MM-101 n=86 Participants 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
Associated Symptoms Such as Vomiting Affected subjects at day 1	23.3 Percentage of subjects
Associated Symptoms Such as Vomiting Affected subjects at day 2	3.5 Percentage of subjects
Associated Symptoms Such as Vomiting Affected subjects at day 3	3.5 Percentage of subjects
Associated Symptoms Such as Vomiting Affected subjects at day 4	3.5 Percentage of subjects

SECONDARY outcome

Timeframe: 96 hours

Population: 387, 278, 200 and 82 stool samples were obtained on day 1, 2, 3 and 4 respectively.

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.

Outcome measures

Measure	IQP-MM-101 n=387 stool samples 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
Stool Consistency Type of Stool Day 1	6.66 score on a scale Standard Deviation 0.84
Stool Consistency Type of Stool Day 2	5.83 score on a scale Standard Deviation 1.33
Stool Consistency Type of Stool Day 3	4.18 score on a scale Standard Deviation 1.50
Stool Consistency Type of Stool Day 4	3.32 score on a scale Standard Deviation 1.25

SECONDARY outcome

Timeframe: 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.

Subjects feeling of nausea was measured on visual analog scale of 0 - 100mm (no nausea to severe nausea).

Outcome measures

Measure	IQP-MM-101 n=86 Participants 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
Severity of Nausea Severity of nausea Day 1	44.8 mm Standard Deviation 29.5
Severity of Nausea Severity of nausea Day 2	28.1 mm Standard Deviation 23.4
Severity of Nausea Severity of nausea Day 3	12.9 mm Standard Deviation 16.0
Severity of Nausea Severity of nausea Day 4	8.3 mm Standard Deviation 13.7

Adverse Events

IQP-MM-101

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	IQP-MM-101 n=99 participants at risk 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
General disorders Cold	2.0% 2/99 • Number of events 2 • 72 hours
General disorders Cough	1.0% 1/99 • Number of events 1 • 72 hours
General disorders Headache	1.0% 1/99 • Number of events 1 • 72 hours
Infections and infestations Tinea Corporis	1.0% 1/99 • Number of events 1 • 72 hours
General disorders Heartburn	1.0% 1/99 • Number of events 1 • 72 hours
Respiratory, thoracic and mediastinal disorders Viral Infection of the Pharynx	1.0% 1/99 • Number of events 1 • 72 hours

Additional Information

Felix Alt

Analyze & Realize

Phone: +49 30 4000 8194

Email: FAlt@a-r.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place