DiarrhoeaNCT01969214
Safety and Efficacy of IQP-MM-101 in Reducing Symptoms of Diarrhoea
A study testing IQP-MM-101 in people with Diarrhoea, run by InQpharm Group at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diarrhoea
- What is being tested?
- IQP-MM-101
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2013to Jul 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label Study to Assess the Safety and Efficacy of IQP-MM-101 in Reducing Symptoms of Diarrhoea
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.
Read the 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.
- Conditions
- Diarrhoea
- Being tested
- IQP-MM-101
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IQP-MM-101Device
Dissolve the effervescent tablets in half a glass of water, to be taken orally
1 tablet, 3 times a day
| Study group | Role | What they receive |
|---|---|---|
| IQP-MM-101 | Experimental | Dissolve the effervescent tablets in half a glass of water,to be taken orally
1 tablet, 3 times a day Receives: Device: IQP-MM-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 96 hours
Secondary outcomes (13)
Time (Hours) From the First Intake to the Last Watery Stool
The last watery stool was assumed as the first-non watery stool
Measured: 96 hours
Number of Daily Defecation
Measured: 96 hours
Number of Watery Stools
Measured: 96 hours
Stool Frequency
The mean number of daily defecation.
Measured: 96 hours
Percentage of Patients Having Recovered Within a Certain Time Period (Defined as Having Achieved the Primary Efficacy Endpoint)
Measured: 72 hours
Abdominal Pain
Subjects feeling of abdominal pain was measured on visual analog scale of 0 - 100mm (no pain to severe pain).
Measured: 96 hours
Time Off From Work
Measured: 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).
Measured: 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").
Measured: 96 hours
Occurrence of Adverse Events (AEs)
Measured: 96 hours
Associated Symptoms Such as Vomiting
Measured: 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.
Measured: 96 hours
Severity of Nausea
Subjects feeling of nausea was measured on visual analog scale of 0 - 100mm (no nausea to severe nausea).
Measured: 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionJun 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiarrhoeaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- InQpharm Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ralf Uebelhack, Principal investigator, analyze & realize GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01969214
- Sponsor's protocol ID
- INQ/015213
- Status last verified
- Jan 2018
- First submitted
- 6 Oct 2013
- Last updated
- 4 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Study to Assess the Safety and Efficacy of IQP-MM-101 in Reducing Symptoms of Diarrhoea
- ClinicalTrials.gov ID
- NCT01969214
- Acronym / sponsor ID
- INQ/015213
- Conditions
- Diarrhoea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- InQpharm GroupIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 25 Oct 2013 (estimated)
- Results
- Posted 4 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IQP-MM-101 | Experimental | Device: IQP-MM-101Dissolve the effervescent tablets in half a glass of water,to be taken orally 1 tablet, 3 times a day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IQP-MM-101Dissolve the effervescent tablets in half a glass of water, to be taken orally 1 tablet, 3 times a day | Device | IQP-MM-101 |
Primary outcome
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)
Time frame: 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).
13 secondary outcomes
Time (Hours) From the First Intake to the Last Watery Stool
Time frame: 96 hours
Number of Daily Defecation
Time frame: 96 hours
Number of Watery Stools
Time frame: 96 hours
Stool Frequency
Time frame: 96 hours
Percentage of Patients Having Recovered Within a Certain Time Period (Defined as Having Achieved the Primary Efficacy Endpoint)
Time frame: 72 hours
Abdominal Pain
Time frame: 96 hours
Time Off From Work
Time frame: 1 week
Evaluation of Subjects' Energy Level
Time frame: 96 hours
Global Evaluation of Safety and Efficacy by Subjects and Investigators
Time frame: 96 hours
Occurrence of Adverse Events (AEs)
Time frame: 96 hours
Associated Symptoms Such as Vomiting
Time frame: 96 hours
Stool Consistency
Time frame: 96 hours
Severity of Nausea
Time frame: 96 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralf Uebelhack principal investigator
analyze & realize GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IQP-MM-101 in people with Diarrhoea, run by InQpharm Group at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: 96 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.