Clinical trial NCT04647045: 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
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome With Constipation
Keywords: Irritable bowel syndrome
cultured milk drinks
interleukin-6
interleukin-8
tumor necrosis factor-alpha
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
Collaborators: name: COTRA ENTERPRISES SDN BHD, MALAYSIA
First posted: 2020-11-30
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Serum cytokine level
timeFrame: 30 days
Secondary outcomes:
measure: Intestinal transit time
timeFrame: 30 days
measure: Fecal pH
timeFrame: 30 days
measure: Constipation related symptoms
timeFrame: 30 days
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Norfilza M Mokhtar
state: Wilayah Persekutuan
Study officials:
References: