An Evaluation of Cultured Milk Drink on Immune Status of Patients With Irritable Bowel Syndrome: Constipation Predominant
Condition: Irritable Bowel Syndrome With Constipation
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation
Study type: Interventional

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.
    

Intervention name(s): Cultured milk drink
Intervention type(s): Dietary Supplement
Intervention description(s): 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.
Other intervention name(s): Vitagen
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Irritable bowel syndrome; cultured milk drinks; interleukin-6; interleukin-8; tumor necrosis factor-alpha