Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000296437
Ethics application status
Approved
Date submitted
30/05/2007
Date registered
4/06/2007
Date last updated
4/06/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
"A Randomised Controlled Trial on the Effectiveness of Synbiotics on the Frequency and Duration of Loose Bowel Movement in Acute Adult Diarrheal Disease.
Scientific title
A Randomised Controlled Trial on the Effectiveness of Synbiotics, Lactobacillus acidophilus and Bifido bifidum in Soy Phytochemical Extract, on the Frequency and Duration of Loose Bowel Movement in Acute Adult Diarrheal Disease.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
loose bowel movement, acute adult diarrhea 1838 0
Condition category
Condition code
Oral and Gastrointestinal 1932 1932 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Synbiotics- is a combination of probiotics and prebiotics.this is composed of live microbial supplements and non digestible sugars that stimulate the growth of those bacteria. The soy phytochemical extract contains Lactobacillus acidophilus and Bifido bifidum given to the randomize test group 1 casule 3 times a day for 4 days per orem. One capsule of the soy phytochemical extract contains 3.5 billion viable probiotic colony forming bacteria. 1.5 billion Bifido bifidum and 1.65 billion Lactobacillus acidophilus and 100mg prebiotic soluble oligosaccharides and soy phytochemical exract. All patient were put on low fat, lactose free diet, in the entire hospital stay. All results will be collected at the end of the 6 months study period, unmask, tabulated and analyze by the authors.
Intervention code [1] 1788 0
Other interventions
Comparator / control treatment
Participants in the control group will be given placebo capsule 3 times a day for 4 days per orem.
Control group
Placebo

Outcomes
Primary outcome [1] 2746 0
Comparing stool consistency and frequency
Timepoint [1] 2746 0
After 6 month of study duration, all collected forms with randomically allocated numbers provided to the patients to answer will be collected by the authors unmasked, tabulated and and entered into a computer using SPSS for windows version 14 software. Wilcoxon Signed Rank test will be utilized for comparing stool consistency and frequency.
Primary outcome [2] 2747 0
Comparing the clinical improvement of symptoms
Timepoint [2] 2747 0
After 6 month of study duration, all collected forms with randomically allocated numbers provided to the patients to answer will be collected by the authors unmasked, tabulated and and entered into a computer using SPSS for windows version 14 software. Sign test is use for comparing the clinical improvement of symptoms. Level of significance is set at 0.05.
Secondary outcome [1] 4638 0
Secondary outcomes were not included in this study
Timepoint [1] 4638 0

Eligibility
Key inclusion criteria
Angeles University Foundation Medical Center (AUFMC) and Rafael Lazatin Memorial Medical Center (RLMMC) patients, admitted for acute diarrheal disease from September 2006 to March 2007.Acute Diarrhea is defined as loose, watery, bowel movement of more than 3x a day non-bloody; loose watery bowel movement of 2 episodes more than patient’s usual BM.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with co-morbidities, those who are diagnose with typhoid infections, amebiasis, no history or current antibiotics or antidiarrheal medication use, overflow diarrhea, antimotility intake, irritable bowel syndrome, history of diabetes mellitus, laxative abuse, malabsorption syndrome, thyroid pathology and those who are having diarrhea for more than a week.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
treatment allocation done by hospital pharmacy based on the generated randomized table by computer. intervention or controlled capsule issued by the pharmacy will be administered by the nurseon duty without knowing what type of medication is he/she administering.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomization using randomization table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
the subjects, investigators, clinician, and medication nurse are blinded.
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
38
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2076 0
Charities/Societies/Foundations
Name [1] 2076 0
Angeles University Foundation Medical Center Department of Internal Medicine
Country [1] 2076 0
Philippines
Primary sponsor type
Individual
Name
Francel Villarin
Address
Country
Secondary sponsor category [1] 1881 0
Commercial sector/Industry
Name [1] 1881 0
Precieze Pharma and Distribution, Philippines
Address [1] 1881 0
Country [1] 1881 0
Philippines

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3860 0
the ethics board of the department of internal medicine in Angeles University Foundation Medical Center a Philippine College of Physician
Ethics committee address [1] 3860 0
Ethics committee country [1] 3860 0
Philippines
Date submitted for ethics approval [1] 3860 0
Approval date [1] 3860 0
Ethics approval number [1] 3860 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27891 0
Address 27891 0
Country 27891 0
Phone 27891 0
Fax 27891 0
Email 27891 0
Contact person for public queries
Name 10977 0
Francel Villarin, M.D.
Address 10977 0
Angeles University Foundation Medical Center, Mac Arthur Hi-way Angeles City Pampanga, (2009)
Country 10977 0
Philippines
Phone 10977 0
+63 9209540878
Fax 10977 0
+63 45 8881688
Email 10977 0
[email protected]
Contact person for scientific queries
Name 1905 0
Francel Villarin, M.D.
Address 1905 0
Angeles University Foundation Medical Center
Mac artur Hi-way Angeles City Philippines (2009)
Mother of Perpetual Help Hospital
Sto. Entierro St.
Angeles City (2009)
Country 1905 0
Philippines
Phone 1905 0
+63 9209540878
Fax 1905 0
+63 45 8881688
Email 1905 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.