Health Condition 1: K928- Other specified diseases of the digestive system
Conditions
Interventions
Intervention1: Bacillus clausii PBC429 (Sachet): For Paediatric 2 Sachets per day (Total 4 billion CFU per day)
and for adult 3 Sachets per day (Total 6 billion CFU per day) for 7 days
Control Inter
Sponsors
Pellucid Lifesciences Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: To be eligible for the study, Participants must meet the following criteria: 1. Male and females aged 2 and 65 years completed years (both inclusive) with symptoms of antibiotic treatment induced diarrhea manifesting within at least 48 hours or more, at the time of screening 2. Participants with diarrhea due to ongoing antibiotic therapy (Participants should be on the initial 3-4 days of antibiotic therapy). 3. Participants have experienced at least three incidences of unformed stool (Type 6 & Type 7 by Bristol Stool form scale) within last 24 hours at the time of screening.(Annexure I). 4. Participants treated with physician s prescribed broad-spectrum antibiotics for the last 5 days (e.g., Beta lactam, lincomycin, cephalosporin and macrolide class). 5. Willing to give written informed consent or assent form by study participants or parents wherever applicable and able to follow all study procedures.
Exclusion criteria
Exclusion criteria: Participants with any of the following conditions will be excluded from the study: 1. Severe dehydration needing hospitalization. 2. Participants with bloody or purulent stool, with pus or mucus. 3. An axillary temperature greater than (greater than) 38.2 C or an oral temperature greater than 38.6 C 4. Symptoms of septicemia (Fever, shivering, or feeling cold, fast heart rate, fast breathing and shortness of breath, sweaty or clammy skin, etc.) 5. Unable to take medication orally or tolerate oral rehydration. 6. Taken probiotics prior to study (2 weeks) or during study other than investigational products. 7. History of gastric ulcer, duodenal ulcer, combined gastric and duodenal ulcers, upper gastrointestinal bleeding, autoimmune gastritis and GERD. 8. Use of any laxative within 1 week before initiating study IP therapy. 9. Use of any muscarine receptor antagonist and gastrin receptor antagonist within 2 weeks before initiating study IP treatments. 10. History of intubations for co-morbidities (chronic lung disease (CLD), congenital heart defects (CHD) or neurologic disorders. 11. Use of any investigational drug currently or within 30 days prior to study entry. 12. Participant with immuno-compromised ailments such as HIV, Hepatitis B. 13. History of any psychiatric disease (including Alzheimer s disease, Parkinson s disease), or any other serious medical illness. 14. Women who are pregnant, breastfeeding, or planning pregnancy during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of participants in the treatment group who achieved a Bristol Stool Scale type 3-4 (formed to normal stools) within 48 hours of initiation of treatment.Timepoint: Visit-1 (Day 1), Visit-2 (Day 03 1), Visit-3(Day 05 1), Visit-4 (Day 08 1) & Visit-5 (Day 14) | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to Resolution of Diarrhea mean time, time taken for participants to achieve a BSS type 3-4 stool (normal to formed stool) from the start of treatment.Timepoint: Visit-1(Day 1), Visit-2(Day 03 1), Visit-3(Day 05 1), Visit-4(Day 08 1) & Visit-5(Day 14);Frequency of Diarrheal Episodes - The number of diarrheal episodes per day in the first 48 hours post-treatment initiation.Timepoint: Visit-1(Day 1), Visit-2(Day 03 1), Visit-3(Day 05 1), Visit-4 (Day 08 1) & Visit-5 (Day 14);Change in Abdominal Pain & other GI symptoms within 24 Hours after initiation of treatment: To assess the change in abdominal pain and other GI symptoms severity using the Gastrointestinal symptoms Questionnaire (GSQ)Timepoint: Visit-1(Day 1), Visit-2(Day 03 1), Visit-3(Day 05 1), Visit-4 (Day 08 1) & Visit-5 (Day 14);Tolerability of IP: To evaluate tolerability based on the frequency, severity, and relationship of adverse events (AEs) to the study product.Timepoint: Visit-2(Day 03 1), Visit-3(Day 05 1), Visit-4 (Day 08 1) & Visit-5 (Day 14);Incidence of clinical and laboratory adverse events throughout the study period. The following lab parameters would be evaluated at baseline and end of study treatment: Complete Blood Count (CBC) Hemoglobin, RBC, WBC, Platelets, Hematocrit, and MCV. Liver Function Tests (LFT) Albumin, ALT, AST, Bilirubin, and Total Protein. Kidney Function Tests (KFT) Blood Urea, BUN, Calcium, eGFR, Sodium, Potassium, Serum Creatinine, and Serum Uric Acid. Urine Analysis (Routine analysis) Colour, pH, Glucose, Protein, Blood & Bilirubin Random Blood Sugar (RBS). Timepoint: Visit-1(Day 1) & Visit-4(Day 08 1) | — |
Countries
India
Contacts
Public ContactDr Sohel Shaikh
Matis Multispeciality Hospital
Outcome results
None listed