Effectiveness of Bacillus Coagulans in improving appetite among patients admitted in hospital
- Registration Number
- CTRI/2018/11/016404
- Lead Sponsor
- Hindu Mission Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1)A SNAQ score greater or equal to 2
2)BMI less than or equal to 19 kg/m2
3)Patient consent
1.Clinically significant eating disorder
2.Overweight with BMI greater or equal to 25 kg/m2
3.Diabetes mellitus
4.Laboratory parameters outside the normal range that are associated with a clinically significant cardiovascular, pulmonologic, hematologic, hepatological, metabolic, or renal disease or that interfere with interpretation of the clinical study or that require medications that are not permitted in the study protocol
5.Elevation of the serum transaminase levels (ALT/AST) to more than 3-times of the upper normal value
6.Elevation of the bilirubin and gamma-glutamyl transferase levels (GGT) to beyond the maximum normal value.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Self-evaluation of appetite by using the simplified nutrition assessment questionnaire (SNAQ) score. <br/ ><br>2.Improvement in the SNAQ score at final follow up as compare to baseline.Timepoint: 10 days
- Secondary Outcome Measures
Name Time Method 1.Number and severity of adverse events (AE) and severe adverse events (SAE) <br/ ><br>2.Median daily oral food intake in [kcal] which will be determined retrospectively and anamnestically by composing a dietary protocol and by conducting a standardized interview. <br/ ><br>3.Median daily energy balance [kcal] (difference between actual food intake and target food intake)determined retrospectively and anamnestically by composing a dietary protocol and by conducting a standardizedTimepoint: 10 days