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

NCT04647045 | Completed DMC

• 1 other identifier: UKM PPI/111/8/JEP-2017-206
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome With Constipation

Keywords

Irritable bowel syndrome; cultured milk drinks; interleukin-6; interleukin-8; tumor necrosis factor-alpha

Outcome Measures

Primary Outcomes (1)

• Serum cytokine level

  Serum cytokine was determined using ELISA method at day 0 and day 30.

  30 days

Secondary Outcomes (3)

• Intestinal transit time

  30 days

• Fecal pH

  30 days

• Constipation related symptoms

  30 days

Study Arms (2)

IBS-C group

ACTIVE COMPARATOR

77 constipation-predominant IBS were given three bottles of 125 ml cultured milk drink daily for 30 days

Dietary Supplement: Cultured milk drink

Non-IBS group

OTHER

88 non-IBS subjects (healthy individuals) were given similar probiotics for 30 days.

Dietary Supplement: Cultured milk drink

Interventions

Cultured milk drink DIETARY_SUPPLEMENT

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.

Also known as: Vitagen

IBS-C group; Non-IBS group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Do not fulfil the Rome III criteria for irritable bowel syndrome

You may not qualify if:

• 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.

Sponsors & Collaborators

• National University of Malaysia: lead
• COTRA ENTERPRISES SDN BHD, MALAYSIA: collaborator

Study Sites (1)

Norfilza M Mokhtar

Kuala Lumpur, Kuala Lumpur, 56000, Malaysia

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: November 30, 2020
• Study Start: May 2, 2017
• Primary Completion: June 30, 2018
• Study Completion: August 1, 2018
• Last Updated: December 1, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)