Colon CancerNCT03072641
Using Probiotics to Reactivate Tumor Suppressor Genes in Colon Cancer
A study testing ProBion Clinica in people with Colon Cancer, run by Vastra Gotaland Region.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- ProBion Clinica
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 3 Jun 2010to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least one malignant tumor in the colon
Who cannot join
- Study subjects with adenomas, or
- who received recent antibiotic therapy or
- consumed probiotics regularly were excluded.
About this study
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.
- Conditions
- Colon Cancer
- Being tested
- ProBion Clinica
- Keywords
- Probiotics, Epigenetics, Microbiota
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProBion ClinicaDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| ProBion Clinica | Experimental | 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. Receives: Dietary Supplement: ProBion Clinica |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in microbiota composition after probiotics use
The microbiota composition is analysed at baseline and after probiotics use in tissue and faeces samples
Measured: 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
Measured: 8-78 days depending on time elapsed from inclusion to surgical removal of tumor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study start3 Jun 2010
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- DuPont Nutrition and Health
- Responsible party
- Principal investigator, Yvonne Wettergren, Vastra Gotaland Region
- Investigators
- Yvonne A Wettergren, PhD, Principal investigator, Dept. of surgery, Sahlgrenska Univ. Hospital, Gothenburg, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03072641
- Sponsor's protocol ID
- ALFGBG-542821
- Status last verified
- Mar 2017
- First submitted
- 1 Mar 2017
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wettergren Y, Rolny P, Lindegren H, Odin E, Rotter Sopasakis V, Keane S, Ejeskar K. Increased MLH1, MGMT, and p16INK4a methylation levels in colon mucosa potentially useful as early risk marker of colon cancer. Mol Cell Oncol. 2025 May 10;12(1):2503069. doi: 10.1080/23723556.2025.2503069. eCollection 2025.
PubMed 40357388Keane 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 35499706Hibberd 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
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Probiotics to Reactivate Tumor Suppressor Genes in Colon Cancer
- ClinicalTrials.gov ID
- NCT03072641
- Acronym / sponsor ID
- ALFGBG-542821
- Conditions
- Colon Cancer
- Keywords
- Probiotics, Epigenetics, Microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- DuPont Nutrition and Health
- Study start
- 3 Jun 2010 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 7 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ProBion Clinica | Experimental | Dietary Supplement: ProBion ClinicaProbiotic 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. |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- At least one malignant tumor in the colon
Key exclusion criteria (3 listed)
- Study subjects with adenomas, or
- who received recent antibiotic therapy or
- consumed probiotics regularly were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProBion Clinica | Dietary supplement | ProBion Clinica |
Primary outcome
Changes in microbiota composition after probiotics use
Time frame: 8-78 days depending on time elapsed from inclusion to surgical removal of tumor
The microbiota composition is analysed at baseline and after probiotics use in tissue and faeces samples
1 secondary outcome
Epigenetic changes after probiotics use
Time frame: 8-78 days depending on time elapsed from inclusion to surgical removal of tumor
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
- Derived from this study: PubMed 40357388Wettergren Y, Rolny P, Lindegren H, Odin E, Rotter Sopasakis V, Keane S, Ejeskar K. Increased MLH1, MGMT, and p16INK4a methylation levels in colon mucosa potentially useful as early risk marker of colon cancer. Mol Cell Oncol. 2025 May 10;12(1):2503069. doi: 10.1080/23723556.2025.2503069. eCollection 2025.
- Derived from this study: PubMed 35499706Keane 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.
- Derived from this study: PubMed 28944067Hibberd 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yvonne A Wettergren, PhD principal investigator
Dept. of surgery, Sahlgrenska Univ. Hospital, Gothenburg, Sweden
Questions about this trial
What is this clinical trial studying?
A study testing ProBion Clinica in people with Colon Cancer, run by Vastra Gotaland Region.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in microbiota composition after probiotics use (time frame: 8-78 days depending on time elapsed from inclusion to surgical removal of tumor). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03072641, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2017.