NCT01969214

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2013

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 25, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
5.7 years until next milestone

Results Posted

Study results publicly available

March 4, 2020

Completed
Last Updated

March 4, 2020

Status Verified

January 1, 2018

Enrollment Period

8 months

First QC Date

October 6, 2013

Results QC Date

January 4, 2016

Last Update Submit

February 20, 2020

Conditions

Diarrhoea

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (13)

  • Time (Hours) From the First Intake to the Last Watery Stool

    96 hours

  • Number of Daily Defecation

    96 hours

  • Number of Watery Stools

    96 hours

  • Stool Frequency

    96 hours

  • Percentage of Patients Having Recovered Within a Certain Time Period (Defined as Having Achieved the Primary Efficacy Endpoint)

    72 hours

  • +8 more secondary outcomes

Study Arms (1)

IQP-MM-101

EXPERIMENTAL

Dissolve the effervescent tablets in half a glass of water,to be taken orally 1 tablet, 3 times a day

Device: IQP-MM-101

Interventions

IQP-MM-101DEVICE

Dissolve the effervescent tablets in half a glass of water, to be taken orally 1 tablet, 3 times a day

IQP-MM-101

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

analyze & realize GmbH

Berlin, 10369, Germany

Location

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Felix Alt
Organization
Analyze & Realize
FAlt@a-r.com
+49 30 4000 8194

Study Officials

  • Ralf Uebelhack

    analyze & realize GmbH

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2013

First Posted

October 25, 2013

Study Start

October 1, 2013

Primary Completion

June 1, 2014

Study Completion

July 1, 2014

Last Updated

March 4, 2020

Results First Posted

March 4, 2020

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)