Effectiveness of Bacillus Coagulans in improving appetite among patients admitted in hospital

A Randomized, Double Blind, Placebo Controlled Study Of Bacillus Coagulans Gbi 30, 6086 And Digestive Enzymes For The Treatment Of Loss Of Appetite In Hospitalized Individuals

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/11/016404

Enrollment

100

Registered

2018-11-22

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Tummy Soft: Tummy soft dry syrup 50 ml bottle: Each 5 ml of Dry syrup contains- Bacillus coagulans GBI 30 6086-500 mn CFU, Alpha Amylase-25 mg, Pepsin-10 mg, Lipase- 1.5 mg. Contro

Eligibility

Inclusion criteria

Inclusion criteria: 1)A SNAQ score greater or equal to 2 2)BMI less than or equal to 19 kg/m2 3)Patient consent

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
1.Self-evaluation of appetite by using the simplified nutrition assessment questionnaire (SNAQ) score. 2.Improvement in the SNAQ score at final follow up as compare to baseline.Timepoint: 10 days	—

Secondary

Measure	Time frame
1.Number and severity of adverse events (AE) and severe adverse events (SAE) 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. 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	—

Measure

Time frame

1.Number and severity of adverse events (AE) and severe adverse events (SAE) 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. 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

—

Countries

India

Contacts

Public ContactDr Melvin George

Hindu Mission Hospital

melvingeorge2003@gmail.com9894133697

Outcome results