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

InQpharm

Status

Completed

Conditions

Diarrhoea

Treatments

Device: IQP-MM-101

Study type

Interventional

Funder types

Industry

Identifiers

NCT01969214

INQ/015213

Details and patient eligibility

About

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.

Full 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.

Enrollment

101 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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