A Comparison of Three Medications to Treat Diarrhea in Adults.

Phase 4

Completed

Interventions: Drug: Loperamide/simeticone 2 mg/125 mg caplets
Drug: Loperamide/simeticone 2 mg/125 mg chewable tablets
Drug: Probiotic Saccharomyces boulardii 250 mg capsules

Brief Summary: A comparison of three medications to treat diarrhea in adults.

Detailed Description: This single (investigator) blind, randomized, 3-arm, parallel-group study design was selected to show non-inferiority of loperamide/simeticone caplets compared to chewable tablets in a heterogeneous subject population aiming at validity of results and reducing bias. The study will also compare the loperamide/simeticone combinations versus a probiotic (Saccharomyces boulardii) in the treatment of acute diarrhea in adults. Probiotics have been used for acute infectious diarrhea to reduce the duration and severity of the illness.

Recruitment & Eligibility

Inclusion Criteria

Male or female at least 18 years of age
Acute diarrhea illness with symptoms onset within 48 hours of study entry
Minimum of 3 unformed stools in 24 hours before study entry
Most recent stool is unformed
Abdominal discomfort/wind (intensity mild to severe) within 4 hours of study entry
Women of childbearing potential must have a negative pregnancy test at screening
Willing to adhere to the prohibitions and restrictions specified in this protocol
Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

Exclusion Criteria

Requiring hospital admission, parenteral hydration or antibiotic therapy Axillary temperature >38.2°C or oral temperature >38.6°C
History or clinical evidence of gross blood or pus in stool in current illness
Signs or symptoms of orthostatic hypotension
Unable to take medication and fluids by mouth
History of chronic gastrointestinal disease, hepatic or renal insufficiency, or other significant medical condition that could be aggravated by untreated acute diarrhea
Immunodeficiency (e.g. those with acquired immunodeficiency syndrome [AIDS] or known human immunodeficiency virus [HIV] infection, or undergoing chemotherapy or radiotherapy)
Intake of antibiotics, oral antifungals, quinidine or ritonavir within 7 days, antidiarrhoeal, promotility drugs (e.g., metoclopramide, domperidone), antiflatulents (e.g., simeticone, activated charcoal) or probiotics or bismuth salts within 48 hours, or any analgesic within 6 hours prior to study entry Hypersensitivity to loperamide, yeast, or any component of study formulations
Pregnant or breast-feeding
Unable to comply with the protocol requirements and schedule
Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study
Use of opiates (as 'recreational' drugs and as painkillers)

Arm && Interventions

Group	Intervention	Description
Loperamide/simeticone Caplets	Loperamide/simeticone 2 mg/125 mg caplets	Drug (including placebo)
Loperamide/simeticone Chewable Tablets	Loperamide/simeticone 2 mg/125 mg chewable tablets	Drug (including placebo)
Probiotic Capsules	Probiotic Saccharomyces boulardii 250 mg capsules	Drug (including placebo)

Primary Outcome Measures

Name	Time	Method
Number of unformed stools	0-24 hours

Secondary Outcome Measures

Name	Time	Method
Time to last unformed stool	Throughout duration of the study
Number of unformed stools	0-12, 12-24, 24-36, 36-48 hours
Time to complete relief of abdominal discomfort	Throughout duration of the study
Time to complete relief of diarrhea	Throughout duration of the study
Proportion of subjects with complete relief of diarrhea	4, 8, 12, 24 and 48 hours
Gas-related abdominal discomfort ratings - change from baseline at subsequent time points	Throughout duration of the study
Proportions of subjects with complete well-being	at 12, 24 and 48 hours.
Subject's evaluation of treatment effectiveness for overall illness relief, diarrhea relief and abdominal discomfort relief	Throughout duration of the study
Number of loperamide/simeticone 2 mg/125 mg caplets or chewable tablets or probiotic (Saccharomyces boulardii) 250 mg capsules used during the study	Throughout duration of the study
Frequency of complete well-being following diarrhea illness	at 7 days follow up
Stool frequency	at 7 days follow up
Frequency of diarrhea relapse	at 7 days follow up
Safety Assessments will consist of monitoring and recording all non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs), their frequency, severity, seriousness, and relationship to the investigational product.	throughout duration of the study (+ 30 days for spontaneously-reported SAEs)

Locations (6): Manipal Goa Hospital
🇮🇳
Goa, India
Dr. Maxwell´s Clinic
🇲🇽
San Miguel de Allende, Guanuajuato, Mexico
Servicios Medicos de la Bahia
🇲🇽
Puerto Vallarta, Jalisco, Mexico
Vrundavan Hospital & Research Centre
🇮🇳
Goa, India
Hospital Amerimed Puerto Vallarta
🇲🇽
Puerto Vallarta, Jalisco, Mexico
North West Medical
🇲🇽
San José del Cabo, Baja California Sur, Mexico