CClinicalTrials.gg
Sign In
CompletedNCT03072641Updated Mar 7, 2017

Using Probiotics to Reactivate Tumor Suppressor Genes in Colon Cancer

An interventional study of ProBion Clinica in Colon Cancer, sponsored by Vastra Gotaland Region. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-07.

Sponsored by Vastra Gotaland Region · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 6 years 8 months after the study started (first participant enrolled Jun 2010, registered Mar 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of the study is to determine if probiotic bacteria have a beneficial effect on the colon cancer-associated microbiota and epigenetic alterations in colon cancer. Dietary supplementation consists of two ProBion Clinica tablets, yielding a daily dose of 1.4 x 10 ˄ 10 Bifidobacterium lactis Bl-04 (ATCC SD5219), 7x10 ˄ 9 Lactobacillus acidophilus NCFM (ATCC 700396), and 0.63 g inulin.

02

Conditions studied

  • Colon Cancer

Browse trials for

Keywords

  • Probiotics
  • Epigenetics
  • Microbiota
03

In context

Colonic Neoplasms

1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.

This study's enrollment of 20 is below the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.

Browse Colonic Neoplasms studies →

Lead sponsor

Vastra Gotaland Region is the lead sponsor of 267 studies on the registry; 107 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • At least one malignant tumor in the colon

Exclusion criteria

Exclusion Criteria:

  • Study subjects with adenomas, or
  • who received recent antibiotic therapy or
  • consumed probiotics regularly were excluded.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    ProBion Clinica

    Probiotic tablets yielding a daily dose of 1.4 x 10 ˄ 10 Bifidobacterium lactis Bl-04 (ATCC SD5219), 7x10 ˄ 9 Lactobacillus acidophilus NCFM (ATCC 700396), and 0.63 g inulin.

    Dietary Supplement: ProBion Clinica

  • No intervention
    Control

Interventions

  • Dietary supplementProBion Clinica
06

What researchers measure

Primary outcomes

  1. Changes in microbiota composition after probiotics use

    The microbiota composition is analysed at baseline and after probiotics use in tissue and faeces samples

    Time frame: 8-78 days depending on time elapsed from inclusion to surgical removal of tumor

Secondary outcomes

  1. Epigenetic changes after probiotics use

    DNA methylation levels are analysed at baseline and after probiotics use in tissue samples

    Time frame: 8-78 days depending on time elapsed from inclusion to surgical removal of tumor

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Keane S, Herring M, Rolny P, Wettergren Y, Ejeskar K. Inflammation suppresses DLG2 expression decreasing inflammasome formation. J Cancer Res Clin Oncol. 2022 Sep;148(9):2295-2311. doi: 10.1007/s00432-022-04029-7. Epub 2022 May 2. PubMed 35499706 ↗
  • Hibberd AA, Lyra A, Ouwehand AC, Rolny P, Lindegren H, Cedgard L, Wettergren Y. Intestinal microbiota is altered in patients with colon cancer and modified by probiotic intervention. BMJ Open Gastroenterol. 2017 Jul 3;4(1):e000145. doi: 10.1136/bmjgast-2017-000145. eCollection 2017. PubMed 28944067 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03072641
Lead sponsor
Vastra Gotaland Region
Collaborators
DuPont Nutrition and Health
Responsible party
Yvonne Wettergren (Associate professor, Vastra Gotaland Region) — Principal investigator
First posted
Mar 7, 2017
Start date
Jun 3, 2010
Primary completion
Mar 2016
Completion
Mar 2016
Last update
Mar 7, 2017

Study contacts

Yvonne A Wettergren, PhD
principal investigator · Dept. of surgery, Sahlgrenska Univ. Hospital, Gothenburg, Sweden

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Colonic Neoplasms→

Other studies from this sponsor

Vastra Gotaland Region

Start the discussion