Health Condition 1: K529- Noninfective gastroenteritis and colitis, unspecified
Conditions
Interventions
Intervention1: Bacillus Clausii ALBCL-3: Each 5 ml oral suspension contains Bacillus clausii spores 2 Billion spores, Purified water q.s.
To treat acute diarrhoea, prevent antibiotic-associated diarr
Sponsors
Amspro Lifesciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Participants must meet all of the following criteria to be eligible for enrolment General Male or female participants presenting with acute diarrhea defined as the passage of 3 or more loose or watery stools per day with onset less than or equal to 72 hours prior to screening Mild to moderate dehydration as assessed clinically by the Investigator Willing and able to comply with study procedures including follow-up assessments and completion of participant caregiver diary Written informed consent obtained prior to any study-related procedure Adult participant consent Paediatrics parent legal guardian consent with age-appropriate assent where applicable Adults age more than 18 years at the time of consent. Diagnosis of acute diarrhea, including Antibiotic-associated diarrhea or Acute infectious diarrhea managed in outparticipant or inparticipant (non-critical) settings Pediatrics Age 6 months to 17 years inclusive Clinically diagnosed acute gastroenteritis or acute diarrhea suitable for oral therapy Females of Childbearing Potential Negative urine pregnancy test at screening Willingness to use acceptable contraception during the study period if applicable
Exclusion criteria
Exclusion criteria: Participants meeting any of the following criteria will be excluded from the study General Exclusion Criteria (All Participants) Severe dehydration requiring immediate intravenous resuscitation Signs of shock sepsis or lifethreatening illness at presentation Known or suspected immunocompromised state including but not limited to HIV with clinical immunodeficiency Ongoing chemotherapy Chronic systemic corticosteroid or immunosuppressive therapy Known short bowel syndrome inflammatory bowel disease or chronic diarrheal disorders Use of any probiotic or synbiotic product within 14 days prior to screening Known hypersensitivity or allergy to Bacillus clausii or any component of the investigational product Participation in another clinical trial within 30 days prior to screening Paediatrics Specific Exclusion Criteria Neonates (Less then 6 months of age) Suspected or confirmed necrotizing enterocolitis Severe malnutrition or critical illness requiring intensive care Any condition that in the Investigators judgment makes oral administration unsafe or inappropriate Adults-Specific Exclusion Criteria Presence of uncontrolled comorbid conditions (eg unstable cardiac hepatic renal or metabolic disease) that could interfere with study participation or outcome assessment Chronic diarrhea (more then 14 days duration) or suspected noninfectious chronic gastrointestinal pathology
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adults To evaluate the effect of Bacillus clausii (ALBCL 3) on the duration of acute diarrhea in adult participants including antibiotic associated and acute infectious diarrhea compared with placebo Pediatrics To evaluate the effect of Bacillus clausii (ALBCL 3) on the proportion of pediatric participants achieving resolution of acute diarrhea within 72 hours compared with placeboTimepoint: From Screening / Baseline (Day 1), Follow-Up 1 (Day 14 2), Follow-Up 2 (Day 30 2) | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate changes in stool frequency and stool consistency over time To assess time to resolution of diarrhea To evaluate recurrence of diarrhea within 30 days after resolution To assess hospitalization related to the index diarrheal episode To evaluate the safety and tolerability of Bacillus clausii (ALBCL 3)Timepoint: From Screening / Baseline (Day 1), Follow-Up 1 (Day 14 2), Follow-Up 2 (Day 30 2) | — |
Countries
India
Contacts
Public ContactAkash Sarkar
Indivirtus Global CRO PVT LTD
Outcome results
None listed