Ignite Creation Date:
2024-05-06 @ 3:28 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04647045
Status:
COMPLETED
Last Update Posted:
2020-12-01
First Post:
2020-11-20
Brief Title:
An Evaluation of Cultured Milk Drink on Immune Status of Patients With Irritable Bowel Syndrome Constipation Predominant
Sponsor:
National University of Malaysia
Organization:
National University of Malaysia
Study Overview
Official Title:
An Evaluation of Cultured Milk Drink on Immune Status of Patients With Constipation Predominant Irritable Bowel Syndrome
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 08 and Type I error was set at 005
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 andor 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 109 cfu Lactobacillus acidophilus LA-5 and Lactobacillus paracasei L CASEI-01 In each 100 ml unit it contains 406 g of fructose 414 g of glucose 029 g of sucrose less than 01 g of maltose and 135 g of lactose Cold chain was maintained below 10C 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
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 andor 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 109 cfu Lactobacillus acidophilus LA-5 and Lactobacillus paracasei L CASEI-01 In each 100 ml unit it contains 406 g of fructose 414 g of glucose 029 g of sucrose less than 01 g of maltose and 135 g of lactose Cold chain was maintained below 10C 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None