| CTRI Number |
CTRI/2018/11/016404 [Registered on: 22/11/2018] Trial Registered Prospectively |
| Last Modified On: |
20/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effectiveness of Bacillus Coagulans in improving appetite among patients admitted in hospital |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pearlsy Rajan |
| Designation |
Consultant- General Medicine |
| Affiliation |
Hindu Mission Hospital |
| Address |
Room No:45 , Rheumatology ,General Medicine Department. No:103,GST Road, West Tambaram,Chennai.
Chennai
TAMIL NADU
600045
India |
| Phone |
7299732733 |
| Fax |
|
| Email |
pearlsyrajan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Melvin George |
| Designation |
Consultant-Clinical Research Department |
| Affiliation |
Hindu Mission Hospital |
| Address |
Room No:101, Clinical Research, Hindu Mission Hospital, 103, GST Road, West Tambaram,Chennai.
No:103 GST Road, West Tambaram,Chennai-45.
Chennai
Chennai
TAMIL NADU
600045
India |
| Phone |
9894133697 |
| Fax |
|
| Email |
melvingeorge2003@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Melvin George |
| Designation |
Consultant-Clinical Research Department |
| Affiliation |
Hindu Mission Hospital |
| Address |
Room No:101, Clinical Research, Hindu Mission Hospital, 103, GST Road, West Tambaram,Chennai.
No:103 GST Road, West Tambaram,Chennai-45.
Chennai
Chennai
TAMIL NADU
600045
India |
| Phone |
9894133697 |
| Fax |
|
| Email |
melvingeorge2003@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hindu Mission Hospital, No:103 GST Road, West Tambaram,Chennai-45. |
|
|
Primary Sponsor
|
| Name |
Hindu Mission Hospital |
| Address |
103, GST road, West Tambaram. |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pearlsy Rajan |
Hindu Mission Hospital |
Room No:45 , Rheumatology ,General Medicine Department No:103,GST Road, West Tambaram,Chennai.
Chennai
TAMIL NADU |
7299732733
pearlsyrajan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ,Hindu Mission Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Indigestion |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Dry syrup 5 ml |
| Intervention |
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. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
1)A SNAQ score greater or equal to 2
2)BMI less than or equal to 19 kg/m2
3)Patient consent
|
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
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. |
10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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 standardized |
10 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
23/11/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Impaired appetite is a common feature of the illness. 10% to 40% of adult patients admitted to hospital exhibit some level of nutritional depletion, with much weight loss, occurring over the period of hospitalization. Nutritional supplements are used in most hospitals. Impaired appetite is a common feature of the illness. 10% to 40% of adult patients admitted to hospital exhibit some level of nutritional depletion, with much weight loss, occurring over the period of hospitalization. Nutritional supplements are used in most hospitals. The mechanism of poor nutritional intake in hospitalized patients is mostly attributed to gastric myoneural inhibition and gastrointestinal hypomotility with delayed gastric emptying. Peptide hormones released from the gut, such as ghrelin and peptide YY (PYY), which stimulate and inhibit the appetite, respectively. Ghrelin is produced by the stomach and its level is highest in the fasting state, rising sharply before, and falling within one hour of, a meal. Peptide YY is a naturally occurring peptide that is released into the circulation by intestinal L-cells following food ingestion. PYY3–36 is the major form of metabolically active PYY in both the gut mucosal endocrine cells and the circulation. Digestive Probiotic: Bacillus Coagulans GBI-30, 6086 is a gram-positive, spore-forming, lactic acid producing bacteria. Because of the spore-forming qualities of GanedenBC30, the bacteria remain dormant at low pH and bile salts of the gastric transit and a 3-year shelf life. Once it reaches the intestines where the environment is favorable with moisture, food source, and temperature conditions, it comes out of its dormant state and germinates. Spores of B. Coagulans are excreted slowly via the feces for approximately 7 days after discontinuation of administration and provides the long-term effect in maintaining the normal gut health. Combining a digestive probiotic with digestive enzymes will offer better relief from indigestion symptoms, both in short and long-term and improve the appetite.
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