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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04647045
Other study ID # UKM PPI/111/8/JEP-2017-206
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2, 2017
Est. completion date August 1, 2018

Study information

Verified date November 2020
Source National University of Malaysia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 165
Est. completion date August 1, 2018
Est. primary completion date June 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Cultured milk drink
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.

Locations

Country Name City State
Malaysia Norfilza M Mokhtar Kuala Lumpur Wilayah Persekutuan

Sponsors (2)

Lead Sponsor Collaborator
National University of Malaysia COTRA ENTERPRISES SDN BHD, MALAYSIA

Country where clinical trial is conducted

Malaysia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Serum cytokine level Serum cytokine was determined using ELISA method at day 0 and day 30. 30 days
Secondary Intestinal transit time Intestinal transit time was determined using red carmine capsule prior to the consumption of probiotics. 30 days
Secondary Fecal pH Litmus pH paper was used to determine fecal pH at day 0 and day 30 30 days
Secondary 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. 30 days
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