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

NCT ID: NCT01969214

Last Updated: 2020-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-07-31

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.

Conditions

Diarrhoea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IQP-MM-101

Dissolve the effervescent tablets in half a glass of water,to be taken orally

1 tablet, 3 times a day

Group Type: EXPERIMENTAL

IQP-MM-101

Intervention Type: DEVICE

Dissolve the effervescent tablets in half a glass of water, to be taken orally

1 tablet, 3 times a day

Interventions

IQP-MM-101

Dissolve the effervescent tablets in half a glass of water, to be taken orally

1 tablet, 3 times a day

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

InQpharm Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ralf Uebelhack

Role: PRINCIPAL_INVESTIGATOR

analyze & realize GmbH

Locations

analyze & realize GmbH

Berlin, , Germany

Countries

Germany

Other Identifiers

INQ/015213

Identifier Type: -

Identifier Source: org_study_id