An Evaluation of Cultured Milk Drink on Immune Status of Patients With Irritable Bowel Syndrome: Constipation Predominant
Primary Purpose
Irritable Bowel Syndrome With Constipation
Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Cultured milk drink
Sponsored by
About this trial
This is an interventional basic science trial for Irritable Bowel Syndrome With Constipation focused on measuring Irritable bowel syndrome, cultured milk drinks, interleukin-6, interleukin-8, tumor necrosis factor-alpha
Eligibility Criteria
Inclusion Criteria:
- Do not fulfil the Rome III criteria for irritable bowel syndrome
Exclusion Criteria:
- constipation due to other medical illnesses such as diabetes mellitus, inflammatory bowel disease, hypothyroidism, colorectal cancer, neurological diseases, major depression, lactose intolerance, pregnancy, breastfeeding women and must not be on chronic opioids or anti- depressants. Participants must not consume any antibiotics, probiotic, prebiotic, symbiotic and/or laxatives less than two weeks before recruitment.
Sites / Locations
- Norfilza M Mokhtar
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
IBS-C group
Non-IBS group
Arm Description
77 constipation-predominant IBS were given three bottles of 125 ml cultured milk drink daily for 30 days
88 non-IBS subjects (healthy individuals) were given similar probiotics for 30 days.
Outcomes
Primary Outcome Measures
Serum cytokine level
Serum cytokine was determined using ELISA method at day 0 and day 30.
Secondary Outcome Measures
Intestinal transit time
Intestinal transit time was determined using red carmine capsule prior to the consumption of probiotics.
Fecal pH
Litmus pH paper was used to determine fecal pH at day 0 and day 30
Constipation related symptoms
Garrigues Questionnaire was used to assess the symptoms at day 0 and day 30. The questions are asked to each participant in the form of 'yes' or 'no'. The symptoms are straining during defecation, passing hard stool, number of bowel movements per week and incomplete emptying sensation after bowel movement. The results were reported as % of patients having the listed symptoms at pre- and post-intervention.
Full Information
NCT ID
NCT04647045
First Posted
November 20, 2020
Last Updated
November 27, 2020
Sponsor
National University of Malaysia
Collaborators
COTRA ENTERPRISES SDN BHD, MALAYSIA
1. Study Identification
Unique Protocol Identification Number
NCT04647045
Brief Title
An Evaluation of Cultured Milk Drink on Immune Status of Patients With Irritable Bowel Syndrome: Constipation Predominant
Official Title
An Evaluation of Cultured Milk Drink on Immune Status of Patients With Constipation Predominant Irritable Bowel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
May 2, 2017 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
August 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National University of Malaysia
Collaborators
COTRA ENTERPRISES SDN BHD, MALAYSIA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Our previous work on the use of probiotics improved the clinical symptoms in irritable bowel syndrome with constipation-predominant. This study would like to explore further use of probiotics in the immune system of the patients with irritable bowel syndrome.
Detailed Description
This is a case control study involving participants who fulfilled the Rome III criteria for constipation-predominant irritable bowel syndrome. The patients were recruited from the Gastroenterology clinic at Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur. A total of 165 participants were recruited based on probability (power) of 0.8 and Type I error was set at 0.05.
The investigators included healthy participants above 18 years old. Those less than 18 years old; constipation due to other medical illnesses such as diabetes mellitus, inflammatory bowel disease, hypothyroidism, colorectal cancer, neurological diseases, major depression, lactose intolerance, pregnancy, breastfeeding women and must not be on chronic opioids or anti- depressants were excluded. Participants must not consume any antibiotics, probiotic, prebiotic, symbiotic and/or laxatives less than two weeks before recruitment.
Participants were required to consume three bottles of 125 ml cultured milk drink daily for 30 days. Each bottle contains 10^9 cfu Lactobacillus acidophilus LA-5 and Lactobacillus paracasei L. CASEI-01. In each 100 ml unit, it contains 4.06 g of fructose, 4.14 g of glucose, 0.29 g of sucrose, less than 0.1 g of maltose and 1.35 g of lactose. Cold chain was maintained below 10°C during storage, transportation and distribution. Prior to consumption of the cultured milk drinks, fecal and blood samples from the participants were obtained to determine their baseline fecal pH and serum cytokines level respectively. Each of the participants answered a food frequency questionnaire to assess their dietary profile (data are not presented in this paper) and the Garrigues Questionnaire to evaluate their clinical symptoms and physical activity. The same parameters were taken following 30 days of cultured milk drinks' consumption.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome With Constipation
Keywords
Irritable bowel syndrome, cultured milk drinks, interleukin-6, interleukin-8, tumor necrosis factor-alpha
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized single-blind case controlled trial was performed in patients who were diagnosed with constipation-predominant irritable bowel syndrome. Each recruited participant was given three bottles of 125 ml cultured milk drink containing 109 cfu Lactobacillus acidophilus LA-5 and Lactobacillus paracasei L. CASEI-01 consumed daily for 30 days. At pre- and post-30-day consumption, fecal pH, ITT, clinical symptoms, IL-6, IL-8 and TNF-α levels were assessed.
Masking
Participant
Allocation
Randomized
Enrollment
165 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IBS-C group
Arm Type
Active Comparator
Arm Description
77 constipation-predominant IBS were given three bottles of 125 ml cultured milk drink daily for 30 days
Arm Title
Non-IBS group
Arm Type
Other
Arm Description
88 non-IBS subjects (healthy individuals) were given similar probiotics for 30 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Cultured milk drink
Other Intervention Name(s)
Vitagen
Intervention Description
Each bottle contains 109 cfu Lactobacillus acidophilus LA-5 and Lactobacillus paracasei L. CASEI-01. In each 100 ml unit, it contains 4.06 g of fructose, 4.14 g of glucose, 0.29 g of sucrose, less than 0.1 g of maltose and 1.35 g of lactose.
Primary Outcome Measure Information:
Title
Serum cytokine level
Description
Serum cytokine was determined using ELISA method at day 0 and day 30.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Intestinal transit time
Description
Intestinal transit time was determined using red carmine capsule prior to the consumption of probiotics.
Time Frame
30 days
Title
Fecal pH
Description
Litmus pH paper was used to determine fecal pH at day 0 and day 30
Time Frame
30 days
Title
Constipation related symptoms
Description
Garrigues Questionnaire was used to assess the symptoms at day 0 and day 30. The questions are asked to each participant in the form of 'yes' or 'no'. The symptoms are straining during defecation, passing hard stool, number of bowel movements per week and incomplete emptying sensation after bowel movement. The results were reported as % of patients having the listed symptoms at pre- and post-intervention.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Do not fulfil the Rome III criteria for irritable bowel syndrome
Exclusion Criteria:
constipation due to other medical illnesses such as diabetes mellitus, inflammatory bowel disease, hypothyroidism, colorectal cancer, neurological diseases, major depression, lactose intolerance, pregnancy, breastfeeding women and must not be on chronic opioids or anti- depressants. Participants must not consume any antibiotics, probiotic, prebiotic, symbiotic and/or laxatives less than two weeks before recruitment.
Facility Information:
Facility Name
Norfilza M Mokhtar
City
Kuala Lumpur
State/Province
Wilayah Persekutuan
ZIP/Postal Code
56000
Country
Malaysia
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The investigators are bound to the Institutional Review Board Universiti Kebangsaan Malaysia Medical Research Ethics Committee rules and regulations where recruited patients identity and data are kept confidential and will only be allowed to access by the research team.
Learn more about this trial
An Evaluation of Cultured Milk Drink on Immune Status of Patients With Irritable Bowel Syndrome: Constipation Predominant
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