An Evaluation of Probiotic in the Clinical Course of Patients With Colorectal Cancer

NCT03782428 | Completed DMC

• 2 other identifiers: FPR.4/244/TRGS/2/2014/UKM/02/3TRGS/2/2014/UKM/02/3
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief Summary

Colorectal cancer (CRC) is the most common cancer for men and the second most common for women. Several studies have shown that gut microbiome may play a role in triggering intestinal inflammation that leads to the development of CRC. Gut microbiome is the collection of microorganisms that inhabit the gut. Therefore, manipulation of the gut microbiome via administration of probiotics may potentially improve the health and nutritional status in patients with CRC. The aims of this study are to investigate the role of probiotic functional foods in reducing CRC-related inflammatory markers and symptom alleviation.Participants will be needed to complete an information details form which includes information on age, medical history, background details and diet. Participants are required to consume the investigational product twice daily for six months. Blood samples will be collected prior to surgery and at 6th months post product consumption. These blood samples will be processed and analysed.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Level of circulating inflammatory cytokines (TNF-α, IFN-γ, IL-6, IL-10, IL-12, IL-17A, IL17C &IL-22) pre and post intervention.

  the level of eight colorectal cancer related inflammatory cytokines (in pg/mL) were measured and compared between pre and post intervention in both probiotic and placebo group.

  Change from pre intervention baseline level at post six months intervention.

Secondary Outcomes (1)

• Number of patients with chemotherapy induced diarrhoea assessed by CTCAE v3.0

  During the six month intervention period.

Study Arms (2)

Probiotic group

ACTIVE COMPARATOR

27 participants received probiotics twice daily for six months

Dietary Supplement: Probiotic

Placebo group

PLACEBO COMPARATOR

25 participants received placebo twice daily for six months

Other: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

30 billions colony-forming unit (CFU) of a mixture of six viable strains including 107 mg of Lactobacillus acidophilus BCMC® 12130, Lactobacillus lactis BCMC® 12451, Lactobacillus casei subsp BCMC® 12313, Bifidobacterium longum BCMC® 02120, Bifidobacterium bifidum BCMC® 02290 and Bifidobacterium infantis BCMC® 02129

Also known as: HEXBIO

Probiotic group

Placebo OTHER

Placebo samples produced were identical to the probiotics in term of taste and texture without live microorganisms.

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and above.
• Diagnosed with colorectal cancer
• Planned for colorectal resection

You may not qualify if:

• Received antibiotics 2 weeks prior to recruitment
• Consumed pro/pre/symbiotic product 2 weeks prior to recruitment,
• Patients with recurrent colorectal cancer
• Advanced metastasis
• Nursing or pregnant women

Sponsors & Collaborators

• Dr. Liyana Zaharuddin: lead

Related Publications (1)

• Zaharuddin L, Mokhtar NM, Muhammad Nawawi KN, Raja Ali RA. A randomized double-blind placebo-controlled trial of probiotics in post-surgical colorectal cancer. BMC Gastroenterol. 2019 Jul 24;19(1):131. doi: 10.1186/s12876-019-1047-4.

  PMID: 31340751 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Associate Professor Dr. Raja Affendi Raja Ali

  Faculty Of Medicine, Universiti Kebangsaan Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: both probiotic and placebo product were labelled as either A or B and was given to the patients through simple randomization.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant Physiology Department, Faculty of Medicine

Model Details: A randomized double-blind placebo controlled trial was performed in patients who were diagnosed with colorectal cancer and planned for colorectal resection. Four weeks postoperative, patients were randomized to receive either placebo or 3g X 1010 probiotic containing six viable microorganism of Lactobacillus and Bifidobacterium strains for six months.

Study Record Dates

• First Submitted: December 16, 2018
• First Posted: December 20, 2018
• Study Start: August 26, 2016
• Primary Completion: November 16, 2018
• Study Completion: November 26, 2018
• Last Updated: December 20, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share