Efficacy of Diosmectite (Smecta®) in the Symptomatic Treatment of Acute Diarrhoea in Adults
Condition: Acute Diarrhoea
MeSH terms: Diarrhea
Intervention: Smecta; Smecta placebo
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 858.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to demonstrate that diosmectite efficacy is superior to placebo
      regarding time to recovery of an acute diarrhoea episode presumed of infectious origin in
      adult subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of written informed consent prior to any study related procedures

          -  Male or female subject (outpatient) legally considered as an adult (age of majority).
             In Czech Republic, the upper limit of age will be 70 years inclusive. In Egypt, the
             upper limit of age will be 60 years inclusive.

          -  Subject has a diagnosis of acute diarrhoea presumed of infectious origin, defined as
             the passage of 3 or more unformed loose or watery stools (rated according to the
             Bristol scale) per day within the last 48 hours without associated alarm symptoms

          -  Subject has, usually, normal bowel habits (Rome III criteria), i.e. at least 3 stools
             per week and no more than 3 stools per day

          -  Subject must be willing and able to comply with study restrictions and willing to
             return to the clinic for the follow up evaluation(s) as specified in the protocol.

        Exclusion criteria related to the acute diarrhoea episode:

          -  At least one of the following alarm symptoms

               -  Bloody diarrhoea*,

               -  pus in the stools*,

               -  fever ≥38°C*,

               -  moderate or severe dehydration according to World Health Organisation (WHO)
                  definition, requiring intravenous (IV) rehydration*,

               -  repeated vomiting*,

               -  persistent abdominal pain* *These symptoms are considered as alarm symptoms

          -  other episode of acute watery diarrhoea within the previous 30 days,

          -  persistent diarrhoea, defined as acutely starting episode of diarrhoea lasting more
             than 14 days,

          -  history of chronic diarrhoea (Rome III criteria); i.e. 3 or more loose or watery
             stools per day for at least 12 weeks, consecutive or not, in the preceding 12 months,

          -  traveller's diarrhoea defined as a diarrhoeal episode due to contamination experienced
             by subjects having travelled in at risk countries, or coming from abroad and
             experiencing locally an acute diarrhoea episode, occurring usually within the first 2
             weeks of the stay in a foreign environment.

        Exclusion criteria related to drugs:

          -  Diarrhoea suspected to be induced by drug for example:

               -  antibiotic therapy, including Clostridium difficile-induced diarrhoea, within 1
                  week before entry in the study,

               -  laxative agent

               -  thyroid hormone (at a nonstabilised dosing),

               -  intake of other prohibited drugs (as specified in the protocol)

          -  anti-diarrhoeal agent intake during the last month,

          -  any subject requiring repeated intake of a drug with a narrow therapeutic margin (as
             specified in the protocol),

          -  history of hypersensitivity to diosmectite or its excipients or placebo components,

          -  subject likely to require treatment during the study with drugs that are not permitted
             by the study protocol (for example, antibiotic agent, anti-diarrhoeal agent,
             antiemetic drug, antispasmodic drug),

          -  use of any investigational medication within the last 30 days before entering this
             study,

          -  subject who previously entered in a clinical study within the past 30 days.

        Other digestive exclusion criteria:

          -  History of gastric or intestinal resection, vagotomy,

          -  known digestive malabsorption disease, including coeliac disease

          -  known lactose intolerance,

          -  any suspicion of abdominal surgery need,

          -  known inflammatory bowel disease.

        Other exclusion criteria:

          -  Known Human immunodeficiency virus (HIV) positive status,

          -  known or suspected immunosuppression,

          -  known severe renal insufficiency (including e-GFR not less than 45 mL/min) or hepatic
             insufficiency,

          -  known endocrine disease or Type II Diabetes Mellitus with HBA1c more than 8,5% or
             insulin-dependent diabetes,

          -  history of, or known current, problems with alcohol abuse and/or known drug addiction
             (cocaine, heroin, hashish…),

          -  previous enrolment in this study,

          -  any mental condition rendering the subject unable to understand the nature, scope and
             possible consequences of the study, and/or evidence of an uncooperative attitude.

          -  Pregnant or lactating women