An Evaluation of Cultured Milk Drink on Immune Status of Patients With Irritable Bowel Syndrome: Constipation Predominant

Irritable Bowel Syndrome With Constipation Clinical Trial

Official title:

An Evaluation of Cultured Milk Drink on Immune Status of Patients With Constipation Predominant Irritable Bowel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04647045
• Other study ID #: UKM PPI/111/8/JEP-2017-206
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Constipation
• Irritable Bowel Syndrome
• Irritable Bowel Syndrome With Constipation
• Syndrome

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