The Effects of Probiotics on Intestinal Permeability in Gastrointestinal Cancer Patients in Chemotherapy

NCT03704727 | Completed

• 1 other identifier: H-18010425
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to test the hypothesis that adjuvant administration of probiotics in cancer patients undergoing chemotherapy can reduce a chemo-induced increased intestinal permeability. Furthermore, we hypothesize that the use of probiotics may reduce the occurrence of gastrointestinal side effects such as diarrhea, abdominal pains, bacterial translocation and infections following chemotherapy.

Conditions

Intestinal Permeability; Gastrointestinal Irritation; Mucositis

Outcome Measures

Primary Outcomes (1)

• Intestinal permeability

  Urinary lactulose-mannitol test

  4 hours

Secondary Outcomes (1)

• Gastrointestinal adverse events

  1 week

Study Arms (1)

probiotic treatment

EXPERIMENTAL

Probiotic: VSL#3 is a probiotic formula containing a mixture of 9x10\^10 CFU/g Lactobacilli strains (Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus casei, and Lactobacillus bulgaricus), 8x10\^10 CFU/g Bifidum strains (Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis) and 20x10\^10 CFU/g Streptococcus thermophilus. Administred orally

Dietary Supplement: Probiotic

Interventions

Probiotic DIETARY_SUPPLEMENT

Probiotics (beneficial microorganisms) VSL#3 is a probiotic formula containing a mixture of 9x10\^10 CFU/g Lactobacilli strains (Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus casei, and Lactobacillus bulgaricus), 8x10\^10 CFU/g Bifidum strains (Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis) and 20x10\^10 CFU/g Streptococcus thermophilus

probiotic treatment

Eligibility Criteria

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

You may qualify if:

• GI cancer (all types) patients undergoing chemotherapy in oncologic department at Rigshospitalet in Copenhagen
• Age \>18 years
• Patients with at least three planned chemo therapy sessions left

You may not qualify if:

• Pregnant
• Patients who don't speak, write or understand Danish
• Known inflammatory bowel diseases or malabsorption
• Chronic kidney disease (2 x upper limit plasma creatinine)
• Neutropenia (\< 1.5 x 109/L neutrophilic granulocytes in peripheral blood)
• Use of antibiotics
• Use of lactulose (laxative) and not able to discontinue three days prior to urin collection (lactulose/mannitol test)
• Use of probiotics

Sponsors & Collaborators

• University of Copenhagen: lead
• Actial Farmaceutica S.r.l.: collaborator
• Nutricia, Inc.: collaborator

Study Sites (1)

Departmen of Oncology, Rigshospital

Copenhagen, 2100 OE, Denmark

Location

MeSH Terms

Conditions

Mucositis

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Jens R Andersen, MD,MPA

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: October 15, 2018
• Study Start: July 1, 2018
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: April 18, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)