Alkem

Subject ID *

Subject Initials *

Investigator *

Centre *

Date of Assessment *

Subject Initials *

Age (in Years) *

Gender *

Male Female

Height (in cm) *

Weight (in Kg) *

Pediatric Patients with diarrhea presented to the OPD *

Yes No

Clinical Signs and Symptoms *

Clinical Diagnosis *

Duration of current illness *

Severity of diarrhea *

No. of diarrheal episode per day *

Stool consistency *

Previous medication for diarrhea used till now (if any)

Concomitant Disease	Duration of Disease	Medication	Dose	Frequency

PULSE (Bpm)

BP (mmhg)

RR (Bpm)

TEMPERATURE (ºF)

SPO2 (%)

Specify others (if available)

Tests	Results
Hb (gm/dL)
RBC (millions/cumm)
WBC (cumm)
Platelets (cumm)
CRP (mg/L)
Stool culture results, if available
Specify Others (if any)

Standard of care medications prescribed for T/t

Medication	Dose	Frequency	Duration

Bacillus clausii spores suspension prescribed *

Yes No

Dose (number of spores) *

Frequency *

Duration *

Brand name *

Date of Assessment *

Total Duration of Probiotic Therapy (days) *

PULSE (Bpm)

BP (mmhg)

RR (Bpm)

TEMPERATURE (ºF)

SPO2 (%)

Specify others (if available)

Tests	Results
Hb (gm/dL)
RBC (millions/cumm)
WBC (cumm)
Platelets (cumm)
CRP (mg/L)
Stool culture results, if available
Specify Others (if any)

Clinical Signs and Symptoms (if any)

Severity of diarrhea *

No. of diarrheal episode per day *

Stool consistency *

Cure Improvement Worsening Mortality

Adverse events noted due to study medication *

Yes No

ADVERSE EVENT(S)
AE. No	Adverse Event Term	Date of onset (DD/MM/YYYY)	Severity	Action Taken	Treatment given	Relationship with Study Drug	Outcome	Serious Adverse Event
1					Yes No			Yes No
2					Yes No			Yes No
3					Yes No			Yes No
4					Yes No			Yes No
Severity: 1- Mild; 2- Moderate; 3- Severe; +Action Taken: 1- No Change in IP, 2- IP Temporarily Interrupted, 3- IP Permanently Discontinued, 4- Other, specify *If ‘Treatment given ‘is ticked as ‘Yes’ then relevant information should be captured on Prior and concomitant Medication Form.Relationship: 1= Related, 2= Not Related ++Outcome: 1 = Resolved, 2= Recovered/ Resolved with Sequelae, 3= Recovering/ Resolving, 4=Not Recovered/ Not Resolved, 5= Fatal/ result in death, 6= Unknown

BC Protocol

ASSESSMENT 1 - BASELINE VISIT - DAY 0

DEMOGRAPHICS and ANTHROPOMETRY

MEDICAL AND SURGICAL HISTORY

CONCOMITANT DISEASE and MEDICATION

VITALS

LABORATORY PARAMETERS

TREATMENT OF CURRENT MEDICAL ILLNESS

ASSESSMENT 2

DATE OF ASSESSMENT

VITALS

LABORATORY PARAMETERS

CLINICAL DATA

ADVERSE EVENTS