N/A
N=101
Safety and Efficacy of IQP-MM-101 in Reducing Symptoms of Diarrhoea
Diarrhoea
Bottom Line
View on ClinicalTrials.gov: NCT01969214 ↗Enrolled (actual)
101
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: 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) — 21.30 hours
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- IQP-MM-101 (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- InQpharm Group
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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) |
21.30 | — |
| SECONDARY Time (Hours) From the First Intake to the Last Watery Stool |
18.17 | — |
| SECONDARY Number of Daily Defecation |
387; 278; 200; 82 | — |
| SECONDARY Number of Watery Stools |
292; 72; 20; 10 | — |
| SECONDARY Stool Frequency |
4.50; 3.23; 2.33; 0.95 | — |
| SECONDARY Percentage of Patients Having Recovered Within a Certain Time Period (Defined as Having Achieved the Primary Efficacy Endpoint) |
25.3; 21.5; 8.9; 7.6; 16.5; 10.1 | — |
| SECONDARY Abdominal Pain |
56.2; 35.3; 18.7; 11.1 | — |
| SECONDARY Time Off From Work |
31.4; 4.7; 11.6; 7.0; 12.8; 24.4 | — |
| SECONDARY Evaluation of Subjects' Energy Level |
67.5; 45.7; 29.5; 16.8 | — |
| SECONDARY Global Evaluation of Safety and Efficacy by Subjects and Investigators |
21; 61; 2; 2; 28; 54 | — |
| SECONDARY Occurrence of Adverse Events (AEs) |
7 | — |
| SECONDARY Associated Symptoms Such as Vomiting |
23.3; 3.5; 3.5; 3.5 | — |
| SECONDARY Stool Consistency |
6.66; 5.83; 4.18; 3.32 | — |
| SECONDARY Severity of Nausea |
44.8; 28.1; 12.9; 8.3 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01969214). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.